Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 12:25 AM
Study NCT ID:
NCT07223060
Status:
COMPLETED
Last Update Posted:
2025-12-11
First Post:
2025-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Toothpaste Containing 0.454% Stannous Fluoride as Compared to a Regular Fluoride Toothpaste Containing 0.76% Sodium Monofluorophosphate in Controlling Supragingival Calculus Formation Over a 12-week Period.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003728', 'term': 'Dental Calculus'}], 'ancestors': [{'id': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014002', 'term': 'Tin Fluorides'}, {'id': 'C012980', 'term': 'fluorophosphate'}], 'ancestors': [{'id': 'D005459', 'term': 'Fluorides'}, {'id': 'D006858', 'term': 'Hydrofluoric Acid'}, {'id': 'D017611', 'term': 'Fluorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017971', 'term': 'Tin Compounds'}, {'id': 'D002327', 'term': 'Cariostatic Agents'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2017-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2025-10-29', 'studyFirstSubmitQcDate': '2025-10-29', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Supragingival calculus formation via Volpe-Manhold Calculus Index', 'timeFrame': 'baseline and 12 week measurement', 'description': 'index for comparing the amount of dental calculus'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Calculus, Dental']}, 'descriptionModule': {'briefSummary': 'To evaluate the comparative clinical efficacy of a test toothpaste containing 0.454% stannous fluoride as compared to a regular fluoride toothpaste containing 0.76% sodium monofluorophosphate in controlling supragingival calculus formation over a 12-week period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects were required to sign an Informed Consent form\n* Subjects had to be in general good health\n* Male and female adults between the ages of 18-70 (inclusive)\n* Six (6) scoreable mandibular anterior teeth free of large restorations or dental prosthetic crowns\n* Subjects were required to possess a Volpe-Manhold Calculus Index of at least 7.0\n* Subjects had to be able to participate for the full duration (20 weeks) of the study\n\nExclusion Criteria:\n\n* Presence of orthodontic appliances or removable prosthesis at the lower jaw or more than one mandibular anterior tooth with a prosthetic crown or veneer\n* Tumor(s) or significant pathology of the soft or hard tissues of the oral cavity\n* Moderate or advanced periodontal disease\n* Five or more carious lesions requiring immediate care\n* Use of antibiotics or steroids any time during one month prior to entry into the study\n* Participation in any other clinical study or panel test\n* Pregnant or breast feeding women\n* History of allergies to dentifrice and personal care ingredients\n* Allergies to dentifrice products\n* Medical reasons that prohibit eating or drinking for 4 hours prior to clinical facility visit.'}, 'identificationModule': {'nctId': 'NCT07223060', 'briefTitle': 'Efficacy of Toothpaste Containing 0.454% Stannous Fluoride as Compared to a Regular Fluoride Toothpaste Containing 0.76% Sodium Monofluorophosphate in Controlling Supragingival Calculus Formation Over a 12-week Period.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Colgate Palmolive'}, 'officialTitle': 'A Randomized, Single-center, Two-cell, Double-blind and Parallel-group Design Clinical Study Conducted in the Bangkok, Thailand Area, to Investigate the Clinical Efficacy of a Test Toothpaste Containing 0.454% Stannous Fluoride as Compared to a Regular Fluoride Toothpaste Containing 0.76% Sodium Monofluorophosphate in Controlling Supragingival Calculus Formation Over a 12-week Period.', 'orgStudyIdInfo': {'id': 'CRO-2017-04-TAR-SNDZ-YPZ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test 1 toothpaste', 'interventionNames': ['Drug: 0.454% stannous fluoride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Test 2 toothpaste', 'interventionNames': ['Drug: 0.76% sodium monofluorophosphate']}], 'interventions': [{'name': '0.454% stannous fluoride', 'type': 'DRUG', 'description': 'brushed twice daily, morning and evening for 2 minutes eact time', 'armGroupLabels': ['Test 1 toothpaste']}, {'name': '0.76% sodium monofluorophosphate', 'type': 'DRUG', 'description': 'brushed twice daily, morning and evening for 2 minutes eact time', 'armGroupLabels': ['Test 2 toothpaste']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10250', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'M U International Oral Science Research, Ltd.', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Dutmanee Seriwatanachai', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Colgate Palmolive', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}