Ignite Creation Date:
2025-12-25 @ 4:34 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT06563518
Status:
COMPLETED
Last Update Posted:
2024-08-21
First Post:
2024-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study of Toothpaste Containing Zinc Lactate as Compared to Colgate Cavity Protection Toothpaste.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005891', 'term': 'Gingivitis'}, {'id': 'D058225', 'term': 'Plaque, Amyloid'}], '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': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C059813', 'term': 'Meridol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2024-08-19', 'studyFirstSubmitQcDate': '2024-08-19', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gingivitis Assessment', 'timeFrame': 'baseline, 3 months and 6 months', 'description': 'A Loe-Silness Gingival Index score from 0 to 3 will be assigned by the examining dentist to all scoreable surfaces of the maxillary and mandibular teeth using a dental light and dental mirror.'}, {'measure': 'Plaque Assessment', 'timeFrame': 'baseline, 3 months and 6 months', 'description': 'A Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed surfaces of the maxillary and mandibular teeth using a dental light and dental mirror'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingivitis', 'Plaque']}, 'referencesModule': {'references': [{'pmid': '39910536', 'type': 'DERIVED', 'citation': 'Seriwatanachai D, Triratana T, Kraivaphan P, Huber N, Poth T, Mateo LR, Stellitano M, Zhang YP. Effectiveness of a novel amine + zinc + fluoride toothpaste in reducing plaque and gingivitis: results of a six-month randomized controlled trial. BMC Oral Health. 2025 Feb 5;25(1):188. doi: 10.1186/s12903-025-05551-z.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this six-month clinical research study is to evaluate the clinical efficacy of two dentifrices - Toothpaste containing zinc lactate and Colgate Cavity Protection Toothpaste in reducing gingivitis and dental plaque in adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects, ages 18-70, inclusive.\n* Availability for the six-month duration of the clinical research study.\n* Good general health.\n* Minimum of 20 uncrowned permanent natural teeth (excluding third molars).\n* Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.\n* Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).\n* Signed Informed Consent Form\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* Antibiotic use any time during the one-month period 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* 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.\n* On any prescription medicines that might interfere with the study outcome.\n* An existing medical condition that prohibits eating or drinking for periods up to 4 hours.\n* History of alcohol or drug abuse.\n* Pregnant or lactating subjects.'}, 'identificationModule': {'nctId': 'NCT06563518', 'briefTitle': 'Clinical Study of Toothpaste Containing Zinc Lactate as Compared to Colgate Cavity Protection Toothpaste.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Colgate Palmolive'}, 'officialTitle': 'The Clinical Investigation of Toothpaste Containing Zinc Lactate as Compared to Colgate Cavity Protection Toothpaste in Reducing Plaque and Gingivitis - a Six-month Study in Thailand', 'orgStudyIdInfo': {'id': 'CRO-2021-10-PGN-MRO-YPZ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Toothpaste', 'interventionNames': ['Drug: Meridol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II', 'description': 'Toothpaste', 'interventionNames': ['Drug: Colgate Cavity Protection']}], 'interventions': [{'name': 'Meridol', 'type': 'DRUG', 'description': 'toothpaste', 'armGroupLabels': ['Group 1']}, {'name': 'Colgate Cavity Protection', 'type': 'DRUG', 'description': 'toothpaste', 'armGroupLabels': ['Group II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Ratchathewi', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Mahidol University', 'geoPoint': {'lat': 13.759, 'lon': 100.53358}}], 'overallOfficials': [{'name': 'Terdphong Triratana', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Managing Director of Dental Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Colgate Palmolive', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}