Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2025-12-25 @ 4:52 PM
Study NCT ID:
NCT06244303
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-06
First Post:
2024-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Research Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis.
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-04-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-29', 'studyFirstSubmitDate': '2024-01-29', 'studyFirstSubmitQcDate': '2024-01-29', 'lastUpdatePostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quigley and Hein Plaque Index', 'timeFrame': 'Baseline, 1-, 3-, 6-, and 12-week', 'description': 'reductions in dental plaque'}, {'measure': 'Loe and Silness Gingival Index', 'timeFrame': 'Baseline, 1-, 3-, 6-, and 12-week', 'description': 'reductions in gingivitis'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Loe and Silness Gingival Index', 'Quigley and Hein Plaque Index'], 'conditions': ['Gingivitis', 'Plaque']}, 'descriptionModule': {'briefSummary': 'Qualified subjects will be enrolled and randomized to one of the two study groups 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 1-, 3-, 6-, and 12-weeks of unsupervised product use at home. 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* Signed Informed Consent Form.\n* Male and female subjects aged 18-70 years, inclusive.\n* Availability for the twelve-week duration of the clinical research study.\n* Good general health based on the opinion of the study investigator\n* Minimum of 20 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\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.\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 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': 'NCT06244303', 'briefTitle': 'Clinical Research Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Colgate Palmolive'}, 'officialTitle': 'Clinical Research Study to Assess the Efficacy of Two Brushing Regimens: 1) a Toothpaste Containing Stannous Fluoride With a Mouthwash Containing Cetylpyridinium Chloride and a Manual Toothbrush as Compared to 2) a Regular Fluoride Toothpaste and Standard Manual Toothbrush in the Reduction of Established Dental Plaque and Gingivitis.', 'orgStudyIdInfo': {'id': 'CRO-2023-11-PG-DWN-CA-BGS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I', 'description': 'manual Tooth Brush + Colgate Total TP (0.454% SnF, 1100 ppm F) Brush 2 x day / 2 mins Colgate Total Mouthwash (CPC+Zn) Swish 20 mL / 30 secs', 'interventionNames': ['Drug: manual Tooth Brush + Colgate Total TP (0.454% SnF, 1100 ppm F)', 'Drug: manual toothbrush + Colgate dental cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group II', 'description': 'Manual Toothbrush +Colgate Great Regular Flavor Toothpaste Brush w/ full ribbon, 2x day / 2mins', 'interventionNames': ['Drug: manual Tooth Brush + Colgate Total TP (0.454% SnF, 1100 ppm F)', 'Drug: manual toothbrush + Colgate dental cream']}], 'interventions': [{'name': 'manual Tooth Brush + Colgate Total TP (0.454% SnF, 1100 ppm F)', 'type': 'DRUG', 'description': 'Toothpaste, toothbrush \\& mouthwash regime', 'armGroupLabels': ['Group I', 'Group II']}, {'name': 'manual toothbrush + Colgate dental cream', 'type': 'DRUG', 'description': 'toothpaste + toothbrush', 'armGroupLabels': ['Group I', 'Group II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92627', 'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Mesa Dental Centre', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}], 'overallOfficials': [{'name': 'Farid Ayad, B.D.S., D.D.S., MSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FAR Oral and Systemic Health Consulting, Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Colgate Palmolive', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}