Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-01-01 @ 5:33 AM
Study NCT ID:
NCT03936569
Status:
COMPLETED
Last Update Posted:
2023-06-08
First Post:
2019-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study to Assess the Plaque and Gingivitis Effects of a Stannous Fluoride Dentifrice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005891', 'term': 'Gingivitis'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-07', 'studyFirstSubmitDate': '2019-05-01', 'studyFirstSubmitQcDate': '2019-05-01', 'lastUpdatePostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Löe-Silness Gingivitis Evaluation', 'timeFrame': 'Baseline', 'description': 'Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).'}, {'measure': 'Löe-Silness Gingivitis Evaluation', 'timeFrame': '1 Month', 'description': 'Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).'}, {'measure': 'Löe-Silness Gingivitis Evaluation', 'timeFrame': '3 Months', 'description': 'Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).'}], 'secondaryOutcomes': [{'measure': 'Turesky Modified Quigley-Hein Index', 'timeFrame': 'Baseline', 'description': 'The Turesky Modified Quigley-Hein Index is a validated assessment of dental plaque based on a scale of 0 (no plaque/debris) to 5 (plaque covering two-thirds or more of the side of the crown or tooth).'}, {'measure': 'Turesky Modified Quigley-Hein Index', 'timeFrame': '1 Month', 'description': 'The Turesky Modified Quigley-Hein Index is a validated assessment of dental plaque based on a scale of 0 (no plaque/debris) to 5 (plaque covering two-thirds or more of the side of the crown or tooth).'}, {'measure': 'Turesky Modified Quigley-Hein Index', 'timeFrame': '3 Months', 'description': 'The Turesky Modified Quigley-Hein Index is a validated assessment of dental plaque based on a scale of 0 (no plaque/debris) to 5 (plaque covering two-thirds or more of the side of the crown or tooth).'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingivitis']}, 'descriptionModule': {'briefSummary': 'The objective of this clinical study is to assess the effects of a 0.454% stannous fluoride dentifrice on gingivitis and plaque after 3 months when compared to a negative control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be at least 18 years of age;\n* Provide written informed consent prior to participation and be given a signed copy of the informed consent form;\n* Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;\n* Have at least 16 gradable teeth;\n* Agree to return for scheduled visits and follow the study procedures;\n* Agree to refrain from use of any non-study oral hygiene products for the duration of the study;\n* Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study.\n\nExclusion Criteria:\n\n* Having taken antibiotic, anti-inflammatory, or anti-coagulant medications within 4 weeks of the Baseline Visit;\n* Have any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease;\n* Removable oral appliances;\n* Fixed facial or lingual orthodontic appliances;\n* Self-reported pregnancy or lactation;\n* Any diseases or condition that might interfere with the safe participation in the study; and\n* Inability to undergo study procedures.'}, 'identificationModule': {'nctId': 'NCT03936569', 'briefTitle': 'A Clinical Study to Assess the Plaque and Gingivitis Effects of a Stannous Fluoride Dentifrice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Procter and Gamble'}, 'officialTitle': 'A 3-Month Clinical Study to Assess the Plaque and Gingivitis Effects of a Stannous Fluoride Dentifrice', 'orgStudyIdInfo': {'id': '2018122'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Marketed Stannous Fluoride Toothpaste', 'description': 'Brush twice daily', 'interventionNames': ['Drug: Marketed Toothpaste']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Marketed Cavity Protection Toothpaste', 'description': 'Brush twice daily', 'interventionNames': ['Drug: Marketed Cavity Protection Toothpaste']}], 'interventions': [{'name': 'Marketed Toothpaste', 'type': 'DRUG', 'description': 'Marketed stannous fluoride (0.454%) toothpaste', 'armGroupLabels': ['Marketed Stannous Fluoride Toothpaste']}, {'name': 'Marketed Cavity Protection Toothpaste', 'type': 'DRUG', 'description': 'Marketed sodium monofluorophosphate (0.76 %) toothpaste', 'armGroupLabels': ['Marketed Cavity Protection Toothpaste']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89146', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Silverstone Research Group', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Procter and Gamble', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}