Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-26 @ 6:18 AM
Study NCT ID:
NCT05330793
Status:
COMPLETED
Last Update Posted:
2023-04-21
First Post:
2022-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of an Oral Probiotic Intervention With or Without a Novel ADP-1 Toothpaste
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of an oral probiotic intervention with or without a novel toothpaste and compared with placebo toothpaste and placebo lozenges.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-19', 'studyFirstSubmitDate': '2022-02-08', 'studyFirstSubmitQcDate': '2022-04-14', 'lastUpdatePostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gingival Index', 'timeFrame': '8 weeks', 'description': '• Gingival Index measures gingival condition of the marginal and interproximal tissues (mesial, lingual, distal, facial) separately on the basis of 0 to 3 with 0=Normal gingiva; 1= Mild inflammation - slight change in color and slight edema but no bleeding on probing; 2= Moderate inflammation - redness, edema and glazing, bleeding on probing; 3= Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding.'}, {'measure': 'Plaque Index', 'timeFrame': '8 weeks', 'description': '• Plaque index is used as a method of recording the presence of plaque on individual tooth surfaces. These surfaces are mesial, distal, buccal and lingual.'}], 'secondaryOutcomes': [{'measure': 'Halitosis', 'timeFrame': '8 weeks', 'description': '• Halitosis will be measured using a digital bad breath checker. The instrument is a small device with a sensor that sits near your mouth. This instrument senses volatile sulfur compounds or VSCs and produces a parts-per-billion (ppb) measurement of the foul-smelling compounds.'}, {'measure': 'Intraoral Imaging', 'timeFrame': '8 weeks', 'description': '• Intraoral imaging of tooth decay can be measured in at least one of the following methods: (1) Using traditional intraoral imaging camera in the dental clinics to visualize tooth decay on the tooth surface, and (2) Using a laser fluorescence pen to detect tooth decay.'}, {'measure': 'SAQ', 'timeFrame': '8 weeks', 'description': 'Self-Assessment Questionnaire will consist of no more than 100 questions examining quality of life across one or several of these domains: (1) social well-being, (2) mental well-being, (3) physical well-being, (4) oral health and (5) dental hygiene and halitosis.dental hygiene and halitosis.'}, {'measure': 'Microbial Community Analysis', 'timeFrame': '8 weeks', 'description': 'Oral swabs from the gum line will be collected using DNA Genotek OMNIgene-ORAL swab kits and stored in the accompanying swab storage tube for microbial community analysis. qPCR testing will be performed in house in USANA.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oral Health']}, 'descriptionModule': {'briefSummary': '* Randomized double-blind, placebo-controlled trial on the effects of an oral probiotic intervention with or without a novel ADP-1 toothpaste Objective\n* Determine the safety and effectiveness of oral probiotic intervention with or without a novel toothpaste and compare with placebo', 'detailedDescription': 'Hypotheses:\n\n1. Subjects using oral probiotics will have better oral health than subjects using placebo toothpaste and placebo lozenges.\n2. Subjects using oral probiotics and ADP-1 toothpaste will have better oral health than subjects using oral probiotics and regular toothpaste, and subjects using regular toothpaste and placebo lozenges.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18 to 65 years old\n* Fluent in English\n* Have mild to moderate gingivitis (i.e., probing depth between 3mm and 5mm)\n* Bleeding on probing on 30%+ areas\n* Able to perform oral hygiene adequately after formal instructions\n* Able to understand and comply with study procedure\n* Able to provide written informed consent\n* Able to come to Roseman Dental Clinics in South Jordan for a 90-minute pre-screening to determine eligibility\n* Able to complete five (90-minute) clinic visits in 2-week intervals\n\nExclusion Criteria:\n\n* • Probing depths less than 3mm\n\n * Breastfeeding, pregnant or trying to become pregnant\n * Currently taking or have taken any of the following within 30 days of enrollment:\n\n * Oral probiotics\n * Antibiotic medications\n * Antifungal medications (e.g., nystatin, clotrimazole, ketoconazole, griseofulvin)\n * Antiseptic medications\n * Immunosuppressant and/or chemotherapeutic medications\n * Medications that could affect gum response measurement (e.g., calcium channel blockers, cyclosporin, anti-seizures like phenytoin and related drugs, anti-inflammatory agents)\n * Frequent alcohol consumption (\\> 2 drinks per day, or \\> 8 per week for women, or \\> 15 per week for men)\n * Use of marijuana (which can cause dry mouth or other conditions) or recreational drugs\n * Use of tobacco products including chewing tobacco and all types of cigarettes (e-cigarettes)\n * Known allergy to any product ingredient (ingredient list provided by USANA)'}, 'identificationModule': {'nctId': 'NCT05330793', 'briefTitle': 'The Effects of an Oral Probiotic Intervention With or Without a Novel ADP-1 Toothpaste', 'organization': {'class': 'INDUSTRY', 'fullName': 'USANA Health Sciences'}, 'officialTitle': 'Randomized Double-blind, Placebo-controlled Trial on the Effects of an Oral Probiotic Intervention With or Without a Novel ADP-1 Toothpaste', 'orgStudyIdInfo': {'id': '202001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': ': Oral probiotic lozenges + placebo toothpaste (toothpaste without ADP-1)', 'description': '1 active oral probiotic with placebo toothpaste', 'interventionNames': ['Dietary Supplement: Oral probiotic', 'Dietary Supplement: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral probiotic lozenges + toothpaste with ADP-1', 'description': 'Oral probiotic and ADP1 toothpaste', 'interventionNames': ['Dietary Supplement: Oral probiotic']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo lozenges (lozenges without oral probiotics) + placebo toothpaste (toothpaste without ADP-1)', 'description': 'Placebo without oral probiotics or ADP1 toothpaste', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Oral probiotic', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['ADP1 toothpaste'], 'description': 'an oral probiotic intervention with or without a novel ADP1 toothpaste', 'armGroupLabels': [': Oral probiotic lozenges + placebo toothpaste (toothpaste without ADP-1)', 'Oral probiotic lozenges + toothpaste with ADP-1']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'placebo without Oral probiotic or toothpaste', 'armGroupLabels': [': Oral probiotic lozenges + placebo toothpaste (toothpaste without ADP-1)', 'Placebo lozenges (lozenges without oral probiotics) + placebo toothpaste (toothpaste without ADP-1)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84095', 'city': 'South Jordan', 'state': 'Utah', 'country': 'United States', 'facility': 'Roseman University of Health Sciences College of Dental Medicine', 'geoPoint': {'lat': 40.56217, 'lon': -111.92966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'USANA Health Sciences', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Roseman University of Health Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}