Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-01-01 @ 7:30 AM
Study NCT ID:
NCT06010732
Status:
COMPLETED
Last Update Posted:
2025-06-15
First Post:
2023-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
In Situ Comparison of the Remineralization Potential of Optimized Fluoride Dentifrice With Control Fluoride Dentifrice
Sponsor:
Organization:
Raw JSON
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Zero', 'organization': 'Indiana University School of Dentistry'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '5 months', 'eventGroups': [{'id': 'EG000', 'title': '0 Ppm F (Placebo)', 'description': 'Each subject used this product during one of the three treatment periods in the crossover study design.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 23, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': '1100 Ppm F as Sodium Fluoride (Positive Control)', 'description': 'Each subject used this product during one of the three treatment periods in the crossover study design.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 16, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '1100 Ppm F as Sodium Fluoride Test Product', 'description': 'Each subject used this product during one of the three treatment periods in the crossover study design.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 19, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Flu', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Cold Sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Lack of balance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Common cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Erythema Mandibular Ridge', 'notes': 'Erythema due to partial denture friction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Prolonged Post Operative Lleus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Dry, cracked lower lip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Burning Sensation Oral Cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Transient Sour Sensation in Oral Cavity', 'notes': 'Transient Sour Sensation in Mandibular Posterior Area, while eating. bilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Sciatica Nerve Pain', 'notes': 'Sciatica, left side pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Kidney Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Fractured Metal Frame of the Mandibular Partial', 'notes': 'The metal framework of the subjects partial denture appliance broke.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Earache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Oral ulcer', 'notes': 'Oral ulcer due to partial denture friction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Herpetic Lesion Upper Lip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Dry and Chapped Lower Lip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Swollen Lower Lip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Tenderness Oral Cavity', 'notes': 'Tenderness Mandibular Left Side Edentulous pre-molar area from Partial Denture Friction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Sinus Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Basel cell carcinoma', 'notes': 'Basel cell carcinoma on the skin of left thigh treated with surgical excision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Bladder Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Worsening of the lower back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Erythema, Hard palate', 'notes': 'Erythema, Hard palate 3X8mm due to food burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Pain anterior gingiva', 'notes': 'Pain from wearing partial at night with C-PAP mask on anterior gingiva', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Erythema buccal mucosa due to cheek bite', 'notes': 'Erythema on left side of buccal mucosa posterior 3mmX3mm due to cheek bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Body ache from shingle vaccine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Worsening of COPD symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Worsening of Asthma symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Muscle Strain', 'notes': 'Muscle Strain - Left shoulder blade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Worsening of Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Stuffy nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}], 'seriousEvents': [{'term': 'Bowel Obstructiion', 'notes': 'Bowel obstruction due to adhesions. The subject had abdominal distress with nausea and vomiting which required hospital admission and surgery from which the subject fully recovered.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}, {'term': 'Migraine vestibulaire', 'notes': 'Subject had a history of migraines and experienced severe migraine that required hospitalization. The subject received treatment with Meclizine and all symptoms resolved in a few days.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Table'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Surface Microhardness Recovery (%SMH Recovery)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '0 Ppm F (Placebo)', 'description': 'Each subject used this product during one of the three treatment periods in the crossover study design.'}, {'id': 'OG001', 'title': '1100 Ppm F as Sodium Fluoride (Positive Control)', 'description': 'Each subject used this product during one of the three treatment periods in the crossover study design.'}, {'id': 'OG002', 'title': '1100 Ppm F as Sodium Fluoride Test Product', 'description': 'Each subject used this product during one of the three treatment periods in the crossover study design.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.4', 'groupId': 'OG000', 'lowerLimit': '19.3', 'upperLimit': '29.5'}, {'value': '51.6', 'groupId': 'OG001', 'lowerLimit': '46.5', 'upperLimit': '56.7'}, {'value': '51.5', 'groupId': 'OG002', 'lowerLimit': '46.5', 'upperLimit': '56.6'}]}]}], 'analyses': [{'pValue': '0.986', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-5.5', 'ciUpperLimit': '5.4', 'pValueComment': 'No alpha-level adjustments for multiple comparisons adjustments were applied.', 'estimateComment': 'Difference calculated as Test-Positive Control', 'groupDescription': 'Based on previous studies we estimate the standard deviation of the differences between treatments in the crossover model to be 20 for % SMH recovery. With a sample size of 58 subjects completing the study, the study had 80% power to detect a difference between any two treatments of 7.5 for % SMH recovery, assuming two-sided tests each conducted at a 5% significance level.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.2', 'ciLowerLimit': '21.7', 'ciUpperLimit': '32.6', 'pValueComment': 'No alpha-level adjustments for multiple comparisons adjustments were applied.', 'estimateComment': 'Difference calculated as Test-Placebo', 'groupDescription': 'Based on previous studies we estimate the standard deviation of the differences between treatments in the crossover model to be 20 for % SMH recovery. With a sample size of 58 subjects completing the study, the study had 80% power to detect a difference between any two treatments of 7.5 for % SMH recovery, assuming two-sided tests each conducted at a 5% significance level.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.2', 'ciLowerLimit': '21.7', 'ciUpperLimit': '32.7', 'pValueComment': 'No alpha-level adjustments for multiple comparisons adjustments were applied.', 'estimateComment': 'Difference calculated as Positive Control-Placebo', 'groupDescription': 'Based on previous studies we estimate the standard deviation of the differences between treatments in the crossover model to be 20 for % SMH recovery. With a sample size of 58 subjects completing the study, the study had 80% power to detect a difference between any two treatments of 7.5 for % SMH recovery, assuming two-sided tests each conducted at a 5% significance level.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at the end of each two-week treatment per', 'description': 'The SMH test was used to assess changes in the mineral status of partially demineralized enamel specimens.\n\n%SMH Recovery = (D1-R)/(D1-B) ×100 B = indentation length (µm) of sound enamel specimen at baseline D1 = indentation length (µm) after in vitro demineralization R = indentation length (µm) after intra-oral exposure.', 'unitOfMeasure': 'Percent Surface Microhardness Recovery', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed using all available data.'}, {'type': 'SECONDARY', 'title': 'Enamel Fluoride Uptake (µg F/cm2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '0 Ppm F (Placebo, Negative Control)', 'description': 'Each subject used this product during one of the three treatment periods in the crossover study design.'}, {'id': 'OG001', 'title': '1100 Ppm F as Sodium Fluoride (Positive Control)', 'description': 'Each subject used this product during one of the three treatment periods in the crossover study design.'}, {'id': 'OG002', 'title': '1100 Ppm F as Sodium Fluoride Test Product', 'description': 'Each subject used this product during one of the three treatment periods in the crossover study design.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.99', 'groupId': 'OG000', 'lowerLimit': '1.72', 'upperLimit': '2.30'}, {'value': '10.32', 'groupId': 'OG001', 'lowerLimit': '8.93', 'upperLimit': '11.93'}, {'value': '11.45', 'groupId': 'OG002', 'lowerLimit': '9.92', 'upperLimit': '13.22'}]}]}], 'analyses': [{'pValue': '0.230', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.32', 'pValueComment': 'No alpha-level adjustments for multiple comparisons adjustments were applied.', 'estimateComment': 'Ratio calculated as Test/Positive Control', 'groupDescription': 'analyzed as log(EFU)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.77', 'ciLowerLimit': '4.86', 'ciUpperLimit': '6.85', 'pValueComment': 'No alpha-level adjustments for multiple comparisons adjustments were applied.', 'estimateComment': 'Ratio calculated as Test/Placebo', 'groupDescription': 'analyzed as log(EFU)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.20', 'ciLowerLimit': '4.37', 'ciUpperLimit': '6.18', 'pValueComment': 'No alpha-level adjustments for multiple comparisons adjustments were applied.', 'estimateComment': 'Ratio calculated as Positive Control/Placebo', 'groupDescription': 'analyzed as log(EFU)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'at the end of each two-week treatment period', 'description': 'The microdrill enamel biopsy technique will be used to analyze the fluoride content of the partially demineralized enamel specimens. Each enamel specimen will be mounted perpendicular to the long axis of a drill bit attached to a specially designed microdrill and drilled to a depth of \\~100 µm through the entire lesion (four cores per specimen). The diameter of the drill hole will be determined using a calibrated microscope interfaced with an image analysis system. The amount of fluoride-uptake by enamel will be calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as µg F/cm2', 'unitOfMeasure': 'µg F/cm2', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed using all available data.'}, {'type': 'SECONDARY', 'title': 'Percent Net Acid Resistance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '0 Ppm F (Placebo, Negative Control)', 'description': 'Each subject used this product during one of the three treatment periods in the crossover study design.'}, {'id': 'OG001', 'title': '1100 Ppm F as Sodium Fluoride (Positive Control)', 'description': 'Each subject used this product during one of the three treatment periods in the crossover study design.'}, {'id': 'OG002', 'title': '1100 Ppm F as Sodium Fluoride Test Product', 'description': 'Each subject used this product during one of the three treatment periods in the crossover study design.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '-2.3', 'upperLimit': '7.4'}, {'value': '34.3', 'groupId': 'OG001', 'lowerLimit': '29.5', 'upperLimit': '39.1'}, {'value': '37.4', 'groupId': 'OG002', 'lowerLimit': '32.6', 'upperLimit': '42.1'}]}]}], 'analyses': [{'pValue': '0.272', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.1', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '8.6', 'pValueComment': 'No alpha-level adjustments for multiple comparisons adjustments were applied.', 'estimateComment': 'Difference calculated as Test-Positive Control', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '34.8', 'ciLowerLimit': '29.3', 'ciUpperLimit': '40.3', 'pValueComment': 'No alpha-level adjustments for multiple comparisons adjustments were applied.', 'estimateComment': 'Difference calculated as Test-Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31.7', 'ciLowerLimit': '26.2', 'ciUpperLimit': '37.3', 'pValueComment': 'No alpha-level adjustments for multiple comparisons adjustments were applied.', 'estimateComment': 'Difference calculated as Positive Control-Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at the end of each two-week treatment period', 'description': '% Net Acid Resistance = \\[(D1-D2) / (D1-B)\\] \\* 100 B= Indentation length (µm) of sound enamel at baseline D1= Indentation length (µm) after first in vitro demineralization D2= Indentation length (µm) after second in vitro demineralization', 'unitOfMeasure': 'Percent Net Acid Resistance', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed using all available data.'}, {'type': 'SECONDARY', 'title': 'Percentage Comparative Acid Resistance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '0 Ppm F (Placebo, Negative Control)', 'description': 'Each subject used this product during one of the three treatment periods in the crossover study design.'}, {'id': 'OG001', 'title': '1100 Ppm F as Sodium Fluoride (Positive Control)', 'description': 'Each subject used this product during one of the three treatment periods in the crossover study design.'}, {'id': 'OG002', 'title': '1100 Ppm F as Sodium Fluoride Test Product', 'description': 'Each subject used this product during one of the three treatment periods in the crossover study design.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.27', 'groupId': 'OG000', 'lowerLimit': '16.26', 'upperLimit': '24.43'}, {'value': '16.40', 'groupId': 'OG001', 'lowerLimit': '12.55', 'upperLimit': '20.39'}, {'value': '13.51', 'groupId': 'OG002', 'lowerLimit': '9.78', 'upperLimit': '17.36'}]}]}], 'analyses': [{'pValue': '0.191', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.32', 'pValueComment': 'No alpha-level adjustments for multiple comparisons adjustments were applied.', 'estimateComment': 'Ratio calculated as Test/Positive Control', 'groupDescription': 'analyzed as log(%CAR+100)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.91', 'ciUpperLimit': '0.98', 'pValueComment': 'No alpha-level adjustments for multiple comparisons adjustments were applied.', 'estimateComment': 'Ratio calculated as Test/Placebo', 'groupDescription': 'analyzed as log(%CAR+100)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.'}, {'pValue': '0.092', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.01', 'pValueComment': 'No alpha-level adjustments for multiple comparisons adjustments were applied.', 'estimateComment': 'Ratio calculated as Positive Control/Placebo', 'groupDescription': 'analyzed as log(%CAR+100)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'at the end of each two-week treatment period', 'description': '% Comparative Acid Resistance = \\[(D2-R) / (D1-B)\\] \\* 100 B= Indentation length (µm) of sound enamel at baseline R= Indentation length (µm) of enamel after in situ remineralization D1= Indentation length (µm) after first in vitro demineralization D2= Indentation length (µm) after second in vitro demineralization', 'unitOfMeasure': 'Percentage Comparative Acid Resistance', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed using all available data.'}, {'type': 'SECONDARY', 'title': 'Integrated Mineral Loss (∆Z)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '0 Ppm F (Placebo, Negative Control)', 'description': 'Each subject used this product during one of the three treatment periods in the crossover study design.'}, {'id': 'OG001', 'title': '1100 Ppm F as Sodium Fluoride (Positive Control)', 'description': 'Each subject used this product during one of the three treatment periods in the crossover study design.'}, {'id': 'OG002', 'title': '1100 Ppm F as Sodium Fluoride Test Product', 'description': 'Each subject used this product during one of the three treatment periods in the crossover study design.'}], 'classes': [{'categories': [{'measurements': [{'value': '998', 'groupId': 'OG000', 'lowerLimit': '917', 'upperLimit': '1087'}, {'value': '703', 'groupId': 'OG001', 'lowerLimit': '646', 'upperLimit': '765'}, {'value': '708', 'groupId': 'OG002', 'lowerLimit': '651', 'upperLimit': '770'}]}]}], 'analyses': [{'pValue': '0.905', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.13', 'pValueComment': 'No alpha-level adjustments for multiple comparisons adjustments were applied.', 'estimateComment': 'Ratio calculated as Test/Positive Control', 'groupDescription': 'analyzed as log(∆Z)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.63', 'ciUpperLimit': '0.80', 'pValueComment': 'No alpha-level adjustments for multiple comparisons adjustments were applied.', 'estimateComment': 'Ratio calculated as Test/Placebo', 'groupDescription': 'analyzed as log(∆Z)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.63', 'ciUpperLimit': '0.79', 'pValueComment': 'No alpha-level adjustments for multiple comparisons adjustments were applied.', 'estimateComment': 'Ratio calculated as Positive Control/Placebo', 'groupDescription': 'analyzed as log(∆Z)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'at the end of each two-week treatment period', 'description': '∆Z= \\[(lesion depth x 87) - area under the curve\\*\\] calculated using Transverse Microradiography software program', 'unitOfMeasure': 'Integrated Mineral Loss (∆Z)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed using all available data.'}, {'type': 'SECONDARY', 'title': 'Lesion Depth (µm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '0 Ppm F (Placebo, Negative Control)', 'description': 'Each subject used this product during one of the three treatment periods in the crossover study design.'}, {'id': 'OG001', 'title': '1100 Ppm F as Sodium Fluoride (Positive Control)', 'description': 'Each subject used this product during one of the three treatment periods in the crossover study design.'}, {'id': 'OG002', 'title': '1100 Ppm F as Sodium Fluoride Test Product', 'description': 'Each subject used this product during one of the three treatment periods in the crossover study design.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.5', 'groupId': 'OG000', 'lowerLimit': '37.2', 'upperLimit': '44.1'}, {'value': '31.2', 'groupId': 'OG001', 'lowerLimit': '28.7', 'upperLimit': '33.9'}, {'value': '30.6', 'groupId': 'OG002', 'lowerLimit': '28.1', 'upperLimit': '33.2'}]}]}], 'analyses': [{'pValue': '0.721', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.09', 'pValueComment': 'No alpha-level adjustments for multiple comparisons adjustments were applied.', 'estimateComment': 'Ratio calculated as Test/Positive Control', 'groupDescription': 'analyzed as log(lesion depth)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.68', 'ciUpperLimit': '0.84', 'pValueComment': 'No alpha-level adjustments for multiple comparisons adjustments were applied.', 'estimateComment': 'Ratio calculated as Test/Placebo', 'groupDescription': 'analyzed as log(lesion depth)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.69', 'ciUpperLimit': '0.86', 'pValueComment': 'No alpha-level adjustments for multiple comparisons adjustments were applied.', 'estimateComment': 'Ratio calculated as Positive Control/Placebo', 'groupDescription': 'analyzed as log(lesion depth)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'at the end of each two-week treatment period', 'description': 'Lesion Depth - L (83% mineral i.e. 95% of the mineral content of sound enamel) determined using Transverse Microradiography software program', 'unitOfMeasure': 'µm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed using all available data.'}, {'type': 'SECONDARY', 'title': 'Maximum Mineral Density at the Surface-zone (SZmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '0 Ppm F (Placebo)', 'description': 'Each subject used this product during one of the three treatment periods in the crossover study design.'}, {'id': 'OG001', 'title': '1100 Ppm F as Sodium Fluoride (Positive Control)', 'description': 'Each subject used this product during one of the three treatment periods in the crossover study design.'}, {'id': 'OG002', 'title': '1100 Ppm F as Sodium Fluoride Test Product', 'description': 'Each subject used this product during one of the three treatment periods in the crossover study design.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.26', 'groupId': 'OG000', 'lowerLimit': '57.40', 'upperLimit': '61.12'}, {'value': '66.17', 'groupId': 'OG001', 'lowerLimit': '64.32', 'upperLimit': '68.01'}, {'value': '65.61', 'groupId': 'OG002', 'lowerLimit': '63.79', 'upperLimit': '67.44'}]}]}], 'analyses': [{'pValue': '0.647', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.56', 'ciLowerLimit': '-2.95', 'ciUpperLimit': '1.84', 'pValueComment': 'No alpha-level adjustments for multiple comparisons adjustments were applied.', 'estimateComment': 'Difference calculated as Test-Positive Control', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.35', 'ciLowerLimit': '3.95', 'ciUpperLimit': '8.75', 'pValueComment': 'No alpha-level adjustments for multiple comparisons adjustments were applied.', 'estimateComment': 'Difference calculated as Test-Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.90', 'ciLowerLimit': '4.49', 'ciUpperLimit': '9.31', 'pValueComment': 'No alpha-level adjustments for multiple comparisons adjustments were applied.', 'estimateComment': 'Difference calculated as Positive Control-Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at the end of each two-week treatment period', 'description': 'SZmax was determined using Transverse Microradiography software program', 'unitOfMeasure': 'Maximum mineral density at the surface-z', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed using all available data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test-Positive-Placebo', 'description': 'Crossover design - Cleaning, 2-3 day non-Fluoride (F) dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 1100 ppm F as sodium fluoride Test Product,1100 ppm F as sodium fluoride (positive control) , 0 ppm F (placebo, negative control)'}, {'id': 'FG001', 'title': 'Test-Placebo-Positive', 'description': 'Crossover design - Cleaning, 2-3 day non-F dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 1100 ppm F as sodium fluoride Test Product, 0 ppm F (placebo, negative control),1100 ppm F as sodium fluoride (positive control)'}, {'id': 'FG002', 'title': 'Positive-Test-Placebo', 'description': 'Crossover design - Cleaning, 2-3 day non-F dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 1100 ppm F as sodium fluoride (positive control), 1100 ppm F as sodium fluoride Test Product, 0 ppm F (placebo, negative control)'}, {'id': 'FG003', 'title': 'Positive-Placebo-Test', 'description': 'Crossover design - Cleaning, 2-3 day non-F dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 1100 ppm F as sodium fluoride (positive control), 0 ppm F (placebo, negative control), 1100 ppm F as sodium fluoride Test Product'}, {'id': 'FG004', 'title': 'Placebo-Test-Positive', 'description': 'Crossover design - Cleaning, 2-3 day non-F dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 0 ppm F (placebo, negative control), 1100 ppm F as sodium fluoride Test Product,1100 ppm F as sodium fluoride (positive control)'}, {'id': 'FG005', 'title': 'Placebo-Positive-Test', 'description': 'Crossover design - Cleaning, 2-3 day non-F dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 0 ppm F (placebo, negative control),1100 ppm F as sodium fluoride (positive control), 1100 ppm F as sodium fluoride Test Product'}], 'periods': [{'title': 'Crossover Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Washout Between Periods 1 and 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Crossover Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'broken denture', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Washout Between Periods 2 and 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Crossover Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'This was a three-way crossover design:\n\n0 ppm F (placebo, negative control;1100 ppm F as sodium fluoride (positive control); 1100 ppm F as sodium fluoride Test Product'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000', 'lowerLimit': '49', 'upperLimit': '85'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '51', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-19', 'size': 382620, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-19T13:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double blind'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-29', 'studyFirstSubmitDate': '2023-08-17', 'resultsFirstSubmitDate': '2025-02-27', 'studyFirstSubmitQcDate': '2023-08-22', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-29', 'studyFirstPostDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Surface Microhardness Recovery (%SMH Recovery)', 'timeFrame': 'at the end of each two-week treatment per', 'description': 'The SMH test was used to assess changes in the mineral status of partially demineralized enamel specimens.\n\n%SMH Recovery = (D1-R)/(D1-B) ×100 B = indentation length (µm) of sound enamel specimen at baseline D1 = indentation length (µm) after in vitro demineralization R = indentation length (µm) after intra-oral exposure.'}], 'secondaryOutcomes': [{'measure': 'Enamel Fluoride Uptake (µg F/cm2)', 'timeFrame': 'at the end of each two-week treatment period', 'description': 'The microdrill enamel biopsy technique will be used to analyze the fluoride content of the partially demineralized enamel specimens. Each enamel specimen will be mounted perpendicular to the long axis of a drill bit attached to a specially designed microdrill and drilled to a depth of \\~100 µm through the entire lesion (four cores per specimen). The diameter of the drill hole will be determined using a calibrated microscope interfaced with an image analysis system. The amount of fluoride-uptake by enamel will be calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as µg F/cm2'}, {'measure': 'Percent Net Acid Resistance', 'timeFrame': 'at the end of each two-week treatment period', 'description': '% Net Acid Resistance = \\[(D1-D2) / (D1-B)\\] \\* 100 B= Indentation length (µm) of sound enamel at baseline D1= Indentation length (µm) after first in vitro demineralization D2= Indentation length (µm) after second in vitro demineralization'}, {'measure': 'Percentage Comparative Acid Resistance', 'timeFrame': 'at the end of each two-week treatment period', 'description': '% Comparative Acid Resistance = \\[(D2-R) / (D1-B)\\] \\* 100 B= Indentation length (µm) of sound enamel at baseline R= Indentation length (µm) of enamel after in situ remineralization D1= Indentation length (µm) after first in vitro demineralization D2= Indentation length (µm) after second in vitro demineralization'}, {'measure': 'Integrated Mineral Loss (∆Z)', 'timeFrame': 'at the end of each two-week treatment period', 'description': '∆Z= \\[(lesion depth x 87) - area under the curve\\*\\] calculated using Transverse Microradiography software program'}, {'measure': 'Lesion Depth (µm)', 'timeFrame': 'at the end of each two-week treatment period', 'description': 'Lesion Depth - L (83% mineral i.e. 95% of the mineral content of sound enamel) determined using Transverse Microradiography software program'}, {'measure': 'Maximum Mineral Density at the Surface-zone (SZmax)', 'timeFrame': 'at the end of each two-week treatment period', 'description': 'SZmax was determined using Transverse Microradiography software program'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Caries', 'Remineralization', 'Fluoride', 'Dentifrice'], 'conditions': ['Caries']}, 'referencesModule': {'references': [{'pmid': '8615941', 'type': 'BACKGROUND', 'citation': 'Clinical Aspects of De/Remineralization of Teeth. Proceedings of Models Conference 1994. Rochester, New York, June 11-14, 1994. Adv Dent Res. 1995 Nov;9(3):169-340. No abstract available.'}, {'pmid': '3463611', 'type': 'BACKGROUND', 'citation': 'Corpron RE, Clark JW, Tsai A, More FG, Merrill DF, Kowalski CJ, Tice TR, Rowe CE. Intraoral effects of a fluoride-releasing device on acid-softened enamel. J Am Dent Assoc. 1986 Sep;113(3):383-8. doi: 10.14219/jada.archive.1986.0202.'}, {'pmid': '6937246', 'type': 'BACKGROUND', 'citation': 'Featherstone JD, Mellberg JR. Relative rates of progress of artificial carious lesions in bovine, ovine and human enamel. Caries Res. 1981;15(1):109-14. doi: 10.1159/000260508. No abstract available.'}, {'pmid': '18285', 'type': 'BACKGROUND', 'citation': 'Cate JM, Arends J. Remineralization of artificial enamel lesions in vitro. Caries Res. 1977;11(5):277-86. doi: 10.1159/000260279. No abstract available.'}, {'pmid': '4219029', 'type': 'BACKGROUND', 'citation': 'Koulourides T, Phantumvanit P, Munksgaard EC, Housch T. An intraoral model used for studies of fluoride incorporation in enamel. J Oral Pathol. 1974;3(4):185-96. doi: 10.1111/j.1600-0714.1974.tb01710.x. No abstract available.'}, {'pmid': '23108261', 'type': 'BACKGROUND', 'citation': 'Lippert F, Butler A, Lynch RJ. Characteristics of methylcellulose acid gel lesions created in human and bovine enamel. Caries Res. 2013;47(1):50-5. doi: 10.1159/000343164. Epub 2012 Oct 25.'}, {'pmid': '23082383', 'type': 'BACKGROUND', 'citation': 'Lippert F, Hara AT. Fluoride dose-response of human and bovine enamel caries lesions under remineralizing conditions. Am J Dent. 2012 Aug;25(4):205-9.'}, {'pmid': '24798979', 'type': 'BACKGROUND', 'citation': 'Lippert F, Lynch RJ. Comparison of Knoop and Vickers surface microhardness and transverse microradiography for the study of early caries lesion formation in human and bovine enamel. Arch Oral Biol. 2014 Jul;59(7):704-10. doi: 10.1016/j.archoralbio.2014.04.005. Epub 2014 Apr 21.'}, {'pmid': '12535435', 'type': 'BACKGROUND', 'citation': 'Marinho VC, Higgins JP, Sheiham A, Logan S. Fluoride toothpastes for preventing dental caries in children and adolescents. Cochrane Database Syst Rev. 2003;2003(1):CD002278. doi: 10.1002/14651858.CD002278.'}, {'pmid': '1592986', 'type': 'BACKGROUND', 'citation': 'Mellberg JR. Hard-tissue substrates for evaluation of cariogenic and anti-cariogenic activity in situ. J Dent Res. 1992 Apr;71 Spec No:913-9. doi: 10.1177/002203459207100S25.'}, {'pmid': '1592992', 'type': 'BACKGROUND', 'citation': 'Proskin HM, Chilton NW, Kingman A. Interim report of the ad hoc committee for the consideration of statistical concerns related to the use of intra-oral models in submissions for product claims approval to the American Dental Association. J Dent Res. 1992 Apr;71 Spec No:949-52. doi: 10.1177/002203459207100S31.'}, {'pmid': '6592201', 'type': 'BACKGROUND', 'citation': 'Sakkab NY, Cilley WA, Haberman JP. Fluoride in deciduous teeth from an anti-caries clinical study. J Dent Res. 1984 Oct;63(10):1201-5. doi: 10.1177/00220345840630100601.'}, {'pmid': '14960006', 'type': 'BACKGROUND', 'citation': 'Twetman S, Axelsson S, Dahlgren H, Holm AK, Kallestal C, Lagerlof F, Lingstrom P, Mejare I, Nordenram G, Norlund A, Petersson LG, Soder B. Caries-preventive effect of fluoride toothpaste: a systematic review. Acta Odontol Scand. 2003 Dec;61(6):347-55. doi: 10.1080/00016350310007590.'}, {'pmid': '20091655', 'type': 'BACKGROUND', 'citation': 'Walsh T, Worthington HV, Glenny AM, Appelbe P, Marinho VC, Shi X. Fluoride toothpastes of different concentrations for preventing dental caries in children and adolescents. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD007868. doi: 10.1002/14651858.CD007868.pub2.'}, {'pmid': '3471346', 'type': 'BACKGROUND', 'citation': 'White DJ. Use of synthetic polymer gels for artificial carious lesion preparation. Caries Res. 1987;21(3):228-42. doi: 10.1159/000261026. No abstract available.'}, {'pmid': '8615944', 'type': 'BACKGROUND', 'citation': 'Zero DT. In situ caries models. Adv Dent Res. 1995 Nov;9(3):214-30; discussion 231-4. doi: 10.1177/08959374950090030501.'}, {'pmid': '2364403', 'type': 'BACKGROUND', 'citation': 'Zero DT, Rahbek I, Fu J, Proskin HM, Featherstone JD. Comparison of the iodide permeability test, the surface microhardness test, and mineral dissolution of bovine enamel following acid challenge. Caries Res. 1990;24(3):181-8. doi: 10.1159/000261263.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the remineralization potential of an optimized fluoride dentifrice to a control fluoride dentifrice in an in situ caries model.', 'detailedDescription': 'This will be a double blind, single center, 3-way crossover design study. Two to three days before the start of each treatment period the subjects will have their teeth cleaned to remove all accessible plaque and calculus and will be provided with a non-fluoride dentifrice to use until their next visit. At the beginning of each testing period, two gauze-covered 4 mm round partially demineralized bovine enamel specimens will be placed in the buccal surface of two posterior denture teeth (the specimen site may extend into the buccal flange area, if needed) of the same side of the partial denture. Once specimens are placed, subjects will wear their partial dentures twenty-four hours a day and use their assigned toothpaste twice daily, as instructed, until their next visit. Specimens will be removed after two weeks, and the subjects will undergo at least a four- to five-day washout period followed by another cleaning and two to three day lead in period. This process will be repeated until all subjects have used all three test products. Changes in the mineral content of the enamel specimens will be assessed using surface microhardness (SMH) and transverse microradiography (TMR). Enamel fluoride uptake (EFU) will be determined using the microdrill enamel biopsy technique. In addition, the net acid resistance (NAR) and the comparative acid resistance (CAR) of the demineralized enamel specimens will be determined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. provide voluntary, written informed consent;\n2. be between 18 and 85 years old;\n3. understand and be willing, able and likely to comply with all study procedures and restrictions;\n4. be wearing a removable mandibular partial denture with sufficient room to accommodate two 4 mm round specimens in the buccal surface of two posterior denture teeth on the same side;\n5. be willing and capable of wearing their removable partial denture 24 hours a day for three (3), two-week treatment periods;\n6. be willing to allow study personnel to drill specimen sites in two denture teeth in the posterior section of one side of their lower partial denture, which may extend into the buccal flange area below the teeth;\n7. be in good medical and dental health with no active caries or periodontal disease; NOTE: subjects presenting at screening with caries may continue in the study if their carious lesions are restored prior to beginning treatment 1; and\n8. have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 mL/min; gum base stimulated whole saliva flow rate ≥ 0.8 mL/min).\n\nExclusion Criteria:\n\n1. currently be pregnant, intending to become pregnant during the study period or breast feeding;\n2. currently have any medical condition that could be expected to interfere with the subject's safety during the study period;\n3. currently be taking antibiotics or have taken antibiotics in the two weeks prior to the beginning treatment 1;\n4. known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients;\n5. have participated in another clinical study or receipt of an investigational drug within 30 days of beginning treatment 1; or\n6. be taking fluoride supplements, required to use a fluoride mouthrinse or have received a professional fluoride treatment in the two weeks preceding specimen placement."}, 'identificationModule': {'nctId': 'NCT06010732', 'briefTitle': 'In Situ Comparison of the Remineralization Potential of Optimized Fluoride Dentifrice With Control Fluoride Dentifrice', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Comparison of the Remineralization Potential of an Optimized Fluoride Dentifrice With a Control Fluoride Dentifrice Using an in Situ Caries Model', 'orgStudyIdInfo': {'id': '23-I-121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Test-Positive-Placebo', 'description': 'Crossover design - Cleaning, 2-3 day non-Fluoride (F) dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 1100 ppm F as sodium fluoride Test Product,1100 ppm F as sodium fluoride (positive control) , 0 ppm F (placebo, negative control)', 'interventionNames': ['Drug: 0 ppm F (placebo, negative control)', 'Drug: 1100 ppm F as sodium fluoride (positive control)', 'Drug: 1100 ppm F as sodium fluoride Test Product']}, {'type': 'OTHER', 'label': 'Test-Placebo-Positive', 'description': 'Crossover design - Cleaning, 2-3 day non-F dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 1100 ppm F as sodium fluoride Test Product, 0 ppm F (placebo, negative control),1100 ppm F as sodium fluoride (positive control)', 'interventionNames': ['Drug: 0 ppm F (placebo, negative control)', 'Drug: 1100 ppm F as sodium fluoride (positive control)', 'Drug: 1100 ppm F as sodium fluoride Test Product']}, {'type': 'OTHER', 'label': 'Positive-Test-Placebo', 'description': 'Crossover design - Cleaning, 2-3 day non-F dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 1100 ppm F as sodium fluoride (positive control), 1100 ppm F as sodium fluoride Test Product, 0 ppm F (placebo, negative control)', 'interventionNames': ['Drug: 0 ppm F (placebo, negative control)', 'Drug: 1100 ppm F as sodium fluoride (positive control)', 'Drug: 1100 ppm F as sodium fluoride Test Product']}, {'type': 'OTHER', 'label': 'Positive-Placebo-Test', 'description': 'Crossover design - Cleaning, 2-3 day non-F dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 1100 ppm F as sodium fluoride (positive control), 0 ppm F (placebo, negative control), 1100 ppm F as sodium fluoride Test Product', 'interventionNames': ['Drug: 0 ppm F (placebo, negative control)', 'Drug: 1100 ppm F as sodium fluoride (positive control)', 'Drug: 1100 ppm F as sodium fluoride Test Product']}, {'type': 'OTHER', 'label': 'Placebo-Test-Positive', 'description': 'Crossover design - Cleaning, 2-3 day non-F dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 0 ppm F (placebo, negative control), 1100 ppm F as sodium fluoride Test Product,1100 ppm F as sodium fluoride (positive control)', 'interventionNames': ['Drug: 0 ppm F (placebo, negative control)', 'Drug: 1100 ppm F as sodium fluoride (positive control)', 'Drug: 1100 ppm F as sodium fluoride Test Product']}, {'type': 'OTHER', 'label': 'Placebo-Positive-Test', 'description': 'Crossover design - Cleaning, 2-3 day non-F dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 0 ppm F (placebo, negative control),1100 ppm F as sodium fluoride (positive control), 1100 ppm F as sodium fluoride Test Product', 'interventionNames': ['Drug: 0 ppm F (placebo, negative control)', 'Drug: 1100 ppm F as sodium fluoride (positive control)', 'Drug: 1100 ppm F as sodium fluoride Test Product']}], 'interventions': [{'name': '0 ppm F (placebo, negative control)', 'type': 'DRUG', 'otherNames': ["Tom's of Maine Silly Strawberry"], 'description': '• Each subject will use this product during one of the three treatment periods in the crossover study design.', 'armGroupLabels': ['Placebo-Positive-Test', 'Placebo-Test-Positive', 'Positive-Placebo-Test', 'Positive-Test-Placebo', 'Test-Placebo-Positive', 'Test-Positive-Placebo']}, {'name': '1100 ppm F as sodium fluoride (positive control)', 'type': 'DRUG', 'otherNames': ['Crest Cavity Protection Toothpaste'], 'description': '• Each subject will use this product during one of the three treatment periods in the crossover study design.', 'armGroupLabels': ['Placebo-Positive-Test', 'Placebo-Test-Positive', 'Positive-Placebo-Test', 'Positive-Test-Placebo', 'Test-Placebo-Positive', 'Test-Positive-Placebo']}, {'name': '1100 ppm F as sodium fluoride Test Product', 'type': 'DRUG', 'otherNames': ['Pronamel Daily Protection'], 'description': '• Each subject will use this product during one of the three treatment periods in the crossover study design.', 'armGroupLabels': ['Placebo-Positive-Test', 'Placebo-Test-Positive', 'Positive-Placebo-Test', 'Positive-Test-Placebo', 'Test-Placebo-Positive', 'Test-Positive-Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University School of dentistry, Oral Health Research institute 415 Lansing Street', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Domenick Zero, DDS, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}, {'name': 'Anderson Hara, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}, {'name': 'Frank Lippert, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'HALEON', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Domenick Zero', 'investigatorAffiliation': 'Indiana University'}}}}