Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT06242769
Status:
COMPLETED
Last Update Posted:
2024-02-05
First Post:
2024-01-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Research Study to Evaluate the Stain Removal Efficacy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002487', 'term': 'Centers for Disease Control and Prevention, U.S.'}], 'ancestors': [{'id': 'D014492', 'term': 'United States Public Health Service'}, {'id': 'D014483', 'term': 'United States Dept. of Health and Human Services'}, {'id': 'D037041', 'term': 'United States Government Agencies'}, {'id': 'D035082', 'term': 'Federal Government'}, {'id': 'D006076', 'term': 'Government'}, {'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-28', 'studyFirstSubmitDate': '2024-01-28', 'studyFirstSubmitQcDate': '2024-01-28', 'lastUpdatePostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite Lobene Stain Index', 'timeFrame': 'measurement at baseline, 3 week & 6 week', 'description': 'subjects will be evaluated for tooth stain by the dental examiner'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Composite Lobene', 'extrinsic stain'], 'conditions': ['Tooth Stain Removal']}, 'descriptionModule': {'briefSummary': 'The objective of this clinical research study is to evaluate the stain removal efficacy of a toothpaste containing stannous fluoride as compared to negative control toothpaste in adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed Informed Consent Form\n* Good general health\n* Male and female subjects, aged 21-70, inclusive\n* Present 12 scoreable natural anterior teeth\n* A minimum mean Composite Lobene Index score of 1 or greater\n* Available for the duration of the study\n* Clinical evidence of a tendency to form extrinsic stain on anterior teeth\n\nExclusion Criteria:\n\n* Presence of orthodontic bands\n* Presence of partial removable dentures\n* Tumor(s) of the soft or hard tissues of the oral cavity\n* Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone)\n* Five or more carious lesions requiring immediate restorative treatment\n* Use of antibiotics or stain inducing medications any time during the one month prior to entry into the study\n* Participation in any other clinical study or test panel within the one month prior to entry into the study\n* Self-reported pregnancy and/or women who are breast feeding\n* Dental prophylaxis received in the past four weeks prior to baseline examinations\n* History of allergies to oral care/personal care consumer products or their ingredients, including allergies to hydrogen peroxide\n* On any prescription medicines that might interfere with the study outcome\n* History of alcohol and/or drug abuse\n* Exposed to a tooth whitening procedure during the last 3 months'}, 'identificationModule': {'nctId': 'NCT06242769', 'briefTitle': 'Clinical Research Study to Evaluate the Stain Removal Efficacy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Colgate Palmolive'}, 'officialTitle': 'Clinical Research Study to Evaluate the Stain Removal Efficacy of a Toothpaste Containing Stannous Fluoride as Compared to Negative Control Toothpaste.', 'orgStudyIdInfo': {'id': 'CRO-2020-04-STN-SNF-PR-BGS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I', 'description': 'Stannous Fluoride Toothpaste (SnF) Colgate Adult Extra Clean soft-bristle toothbrush brushing 2 X day for 2 min', 'interventionNames': ['Drug: Stannous Fluoride Toothpaste (SnF)', 'Drug: Colgate Fluoride Toothpaste (CDC)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group II', 'description': 'Fluoride Toothpaste (CDC) Colgate Adult Extra Clean soft-bristle toothbrush brushing 2 X day for 2 min', 'interventionNames': ['Drug: Stannous Fluoride Toothpaste (SnF)', 'Drug: Colgate Fluoride Toothpaste (CDC)']}], 'interventions': [{'name': 'Stannous Fluoride Toothpaste (SnF)', 'type': 'DRUG', 'description': 'test', 'armGroupLabels': ['Group I', 'Group II']}, {'name': 'Colgate Fluoride Toothpaste (CDC)', 'type': 'DRUG', 'description': 'negative control', 'armGroupLabels': ['Group I', 'Group II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00927', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Dental Research Associates, Inc.', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Augusto R Elias-Boneta, DMD, MSD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dental Research Associates, Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Colgate Palmolive', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}