Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-02-26 @ 12:43 AM
Study NCT ID:
NCT06430060
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Clinical Investigation of Colgate Dual Zinc Toothpaste as Compared to Colgate Cavity Protection Toothpaste in Controlling Established Plaque and Gingivitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003773', 'term': 'Dental Plaque'}, {'id': 'D005891', 'term': 'Gingivitis'}], 'ancestors': [{'id': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C432564', 'term': 'green tea bioflavonoid, zinc ascorbate-containing toothpaste'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-13', 'studyFirstSubmitDate': '2024-05-21', 'studyFirstSubmitQcDate': '2024-05-24', 'lastUpdatePostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Loe-Silness Gingival Index score', 'timeFrame': 'baseline, 2 week, 6 week, 3 month', '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. A whole mouth mean score for each subject will be determined by adding the values given by the examining dentist to each scoreable surface and dividing that number by the total number of surfaces scored.'}, {'measure': 'Quigley-Hein Plaque Index score', 'timeFrame': 'baseline, 2 week, 6 week, 3 month', '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. A whole mouth score for each subject will be determined by adding the values given by the dental examiner to each scoreable surface and dividing that number by the total number of surfaces scored.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Plaque, Dental', 'Gingivitis']}, 'descriptionModule': {'briefSummary': 'Qualified subjects will be enrolled and randomized to either one of the two study groups described above based on their initial Plaque and Gingivitis scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after three months of product use. All subjects will be followed for adverse events throughout the study.'}, '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 three-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 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 which prohibits eating or drinking for periods up to 4 hours.\n* History of alcohol or drug abuse.\n* Pregnant or lactating subjects'}, 'identificationModule': {'nctId': 'NCT06430060', 'briefTitle': 'The Clinical Investigation of Colgate Dual Zinc Toothpaste as Compared to Colgate Cavity Protection Toothpaste in Controlling Established Plaque and Gingivitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Colgate Palmolive'}, 'officialTitle': 'The Clinical Investigation of Colgate Dual Zinc Toothpaste as Compared to Colgate Cavity Protection Toothpaste in Controlling Established Plaque and Gingivitis (A Threemonth Clinical Study)', 'orgStudyIdInfo': {'id': 'CRO-2024-03-GIN-DZN-CN-YPZ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Colgate Dual Zinc Toothpaste', 'description': 'toothpaste', 'interventionNames': ['Drug: zinc containing toothpaste']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Colgate Cavity Protection Toothpaste', 'description': 'toothpaste', 'interventionNames': ['Drug: MFP Fluoride toothpaste']}], 'interventions': [{'name': 'zinc containing toothpaste', 'type': 'DRUG', 'description': 'Toothpaste', 'armGroupLabels': ['Colgate Dual Zinc Toothpaste']}, {'name': 'MFP Fluoride toothpaste', 'type': 'DRUG', 'description': 'toothpaste', 'armGroupLabels': ['Colgate Cavity Protection Toothpaste']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Dental Institute of Chengdu', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Deyu Hu, DDS, MS', 'role': 'CONTACT', 'email': 'hudeyu@vip.sina.com', 'phone': '86-1390-803-4990'}], 'overallOfficials': [{'name': 'Deyu Hu, DDS, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West China Dental Institute of Chengdu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Colgate Palmolive', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}