Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-01-07 @ 12:53 PM
Study NCT ID:
NCT04221334
Status:
COMPLETED
Last Update Posted:
2020-01-09
First Post:
2019-09-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Investigation Examining Plaque and Gingivitis Connected Toothbrush Compared to Non-Connected Toothbrush
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005891', 'term': 'Gingivitis'}, {'id': 'D003773', 'term': 'Dental Plaque'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Product Code: XX Brush twice daily (morning and evening) for at least 2 minutes each time Cover the entire length of bristles with toothpaste'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-07', 'studyFirstSubmitDate': '2019-09-30', 'studyFirstSubmitQcDate': '2020-01-07', 'lastUpdatePostDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in mean dental plaque', 'timeFrame': '3 and 6 weeks of product use', 'description': 'Reduction in plaque measurement is served as primary efficacy variable toothbrush for 6 weeks for each subject.'}, {'measure': 'change in mean gingivitis', 'timeFrame': '3 and 6 weeks of product use', 'description': 'gingivitis measurement is served as secondary efficacy variable'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Gingivitis', 'Plaque, Dental']}, 'descriptionModule': {'briefSummary': 'The objective of this clinical research study is to assess plaque and gingivitis reductions of Connected Toothbrush compared to Non-Connected Toothbrush over a six-week clinical study.', 'detailedDescription': 'A phase II randomized, single-center, two-cell, examiner-blind and parallel-group clinical study conducted in the Loma Linda, California area, to investigate the clinical efficacy of a connected power toothbrush as compared to a non-connected power toothbrush in reducing dental plaque and gingivitis as measured by the Rustogi Modification of the Navy Plaque Index and Löe and Silness Gingival Index over a 6-week period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. • Male and female subjects had to be between the ages of 18 and 70 (inclusive),\n2. • Subjects needed to be available for the duration (6 weeks) of the study,\n3. • Subjects had to possess minimum of 20 uncrowned permanent natural teeth (excluding third molars),\n4. • Subjects were required to present and an initial mean gingivitis score of at least 1.0 as determined by the use of the Löe-Silness Gingival Index,\n5. • Subjects were required to present an initial mean plaque index of at least 0.6 as determined by the use of the Rustogi Modification of the Navy Plaque Index,\n6. • Subjects had to sign an Informed Consent form,\n7. • Subjects had to be in general good health and\n8. • Subjects with no known history of allergies to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the dental/medical professional monitoring of the study.\n\nExclusion:\n\n1. • Medical condition which require pre-medication prior to dental visits/procedures,\n2. • The presence of partial removable dentures,\n3. • Subjects who had advanced periodontal disease (gum disease),\n4. • Five (5) or more decayed or untreated dental sites at screening (cavities),\n5. • Subjects with diseases of the soft or hard oral tissues,\n6. • Subjects with orthodontic appliances/bands/lingual bars that interfere with any clinical assessment (plaque scoring),\n7. • Dry mouth as a result of a medication or medical condition,\n8. • Use of drugs that can currently affect salivary flow,\n9. • Use of antibiotics one (1) month prior to or during this study,\n10. • Use of any over the counter medications other than analgesics that could interfere with the study at PI discretion,\n11. • Chronic (\\>3 3 times/week) use of medications that are known to affect gingival tissues including steroids or non-steroidal anti-inflammatory medications or the listed medications (phenytoin, calcium antagonists, Coumadin, cyclosporine),\n12. • Any diseases that might affect the assessment of the study treatment or gingival tissues (rheumatoid arthritis, Crohn's disease, diabetes), ongoing chemotherapy for cancer, radiation therapy for head and neck cancer,\n13. • Pregnant or breast-feeding women were excluded from the study,\n14. • Subjects who participated in any other clinical study in the month preceding this study,\n15. • Allergic to common dentifrice ingredients,\n16. • Medical condition which prohibits not eating/drinking or chewing gum for 4 hours prior to their scheduled visit,\n17. • Immune compromised individuals (AIDS, immune suppressive drug therapy) and\n18. • History of infectious disease or other blood borne diseases (Hepatitis series, HIV)."}, 'identificationModule': {'nctId': 'NCT04221334', 'acronym': 'Connected', 'briefTitle': 'Clinical Investigation Examining Plaque and Gingivitis Connected Toothbrush Compared to Non-Connected Toothbrush', 'organization': {'class': 'INDUSTRY', 'fullName': 'Colgate Palmolive'}, 'officialTitle': 'Clinical Investigation Examining Plaque and Gingivitis Reductions of Connected Toothbrush Compared to Non-Connected Toothbrush: a Six-week Clinical Study in California', 'orgStudyIdInfo': {'id': 'CRO-2018-12-CTB-PLA-LLU-YPZ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Experimental Toothbrush 1', 'description': '1\\. A connected power toothbrush; brushed twice daily (morning and evening) for two (2) minutes, with Colgate Cavity Protection Toothpaste; Oral.', 'interventionNames': ['Device: Electric Toothbrush', 'Other: oral health care application']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Experimental Toothbrush 2', 'description': '2\\. A non-connected power toothbrush; brushed twice daily (morning and evening) for two (2) minutes, with Colgate Cavity Protection Toothpaste; Oral.', 'interventionNames': ['Device: Electric Toothbrush']}], 'interventions': [{'name': 'Electric Toothbrush', 'type': 'DEVICE', 'description': 'Electric Toothbrush used to remove dental plaque and resolve gingivitis', 'armGroupLabels': ['Experimental Toothbrush 1', 'Experimental Toothbrush 2']}, {'name': 'oral health care application', 'type': 'OTHER', 'description': 'phone application that shows the user brushing efficiency real time', 'armGroupLabels': ['Experimental Toothbrush 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92350', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}], 'overallOfficials': [{'name': 'Yiming Yi, DDS/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loma Linda University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Colgate Palmolive', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Loma Linda University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}