Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-26 @ 12:57 AM
Study NCT ID:
NCT06300866
Status:
COMPLETED
Last Update Posted:
2024-03-08
First Post:
2024-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gingivitis Reduction After Use of 0.45% Stannous Fluoride Toothpaste
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-03', 'studyFirstSubmitDate': '2024-03-03', 'studyFirstSubmitQcDate': '2024-03-03', 'lastUpdatePostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Whole-Mouth Gingivitis Measurement', 'timeFrame': 'baseline, 3 months and 6 months', 'description': 'difference of reduction in gingival index'}, {'measure': 'Whole-Mouth Dental Plaque Measurement', 'timeFrame': 'baseline, 3 months and 6 months', 'description': 'difference of reduction in plaque index'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Loe and Silness Gingival Index', 'Quigley and Hein Plaque Index'], 'conditions': ['Gingivitis', 'Plaque, Dental']}, 'descriptionModule': {'briefSummary': 'The 6-month clinical study was designed to investigate clinical efficacy on plaque and gingivitis for the stannous fluoride containing toothpaste (SNAP) compared to Colgate Cavity Protection Toothpaste after 3 and 6 months of product use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Potential subjects must meet all of the following criteria\n* Subjects, ages 18-70, inclusive\n* Availability for the six-month duration of the clinical research study\n* Good general health\n* Initial gingivitis index of at least 1.0 as determined by the use of the Loe-Silness Gingival Index\n* Initial plaque index of at least 1.5 as determined by the use of the Quigley-Hein Plaque Index\n* Signed Informed Consent Form\n\nExclusion Criteria:\n\n* Presence of orthodontic appliances\n* Presence of partial removable dentures\n* Tumor(s) of the soft or hard tissues of the oral cavity\n* Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study\n* Five or more carious lesions requiring immediate restorative treatment\n* Antibiotic use any time during the one-month period prior to entry into the study -Participation in any other clinical study or test panel within the one month prior to entry into the study\n* Dental prophylaxis during the past two weeks prior to baseline examinations\n* History of allergies to oral care/personal care consumer products or their ingredients -On any prescription medicines that might interfere with the study outcome\n* An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours\n* History of alcohol and/or drug abuse\n* Self-reported pregnancy and/or lactating subjects.'}, 'identificationModule': {'nctId': 'NCT06300866', 'briefTitle': 'Gingivitis Reduction After Use of 0.45% Stannous Fluoride Toothpaste', 'organization': {'class': 'INDUSTRY', 'fullName': 'Colgate Palmolive'}, 'officialTitle': 'The Clinical Investigation of Stannous Fluoride Containing Toothpaste Compared to Colgate Cavity Protection Toothpaste in Reducing Plaque and Gingivitis - a Six-month Study in California', 'orgStudyIdInfo': {'id': 'CRO-2020-04-PGN-LLU-YPZ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I', 'description': 'toothpaste brushing 2x daily morning \\& evening for 2 minutes', 'interventionNames': ['Drug: Test', 'Drug: Control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II', 'description': 'toothpaste brushing 2x daily morning \\& evening for 2 minutes', 'interventionNames': ['Drug: Test', 'Drug: Control']}], 'interventions': [{'name': 'Test', 'type': 'DRUG', 'description': 'test toothpaste containing 0.45% stannous fluoride', 'armGroupLabels': ['Group I', 'Group II']}, {'name': 'Control', 'type': 'DRUG', 'description': 'toothpaste containing 0.76% sodium monofluorophosphate', 'armGroupLabels': ['Group I', 'Group II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92350', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University School of Dentistry', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}], 'overallOfficials': [{'name': 'Yiming Li, DDS MSD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loma Linda University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Colgate Palmolive', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}