Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT06048627
Status:
COMPLETED
Last Update Posted:
2025-05-21
First Post:
2023-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anti-gingivitis Mouthrinse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005891', 'term': 'Gingivitis'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-16', 'studyFirstSubmitDate': '2023-09-16', 'studyFirstSubmitQcDate': '2023-09-16', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Whole-mouth Mean Modified Gingival Index (MGI)', 'timeFrame': 'Baseline, 3 weeks, 12 weeks, 24 weeks', 'description': 'Gingivitis, gingival severity and gingival, interproximal scores as measured by the Gingival Index as difference from baseline to 24 weeks between the study groups.'}], 'secondaryOutcomes': [{'measure': 'Turesky Modification of the Quigley Hein Plaque Index (PI)', 'timeFrame': 'Baseline, 3 weeks, 12 weeks, 24 weeks', 'description': 'Plaque, plaque severity and plaque interproximal scores as measured by the Plaque Index as difference from baseline to 24 weeks between the study groups and at each time-point.'}, {'measure': 'Intraoral scans', 'timeFrame': 'Baseline, 3 weeks, 12 weeks, 24 weeks', 'description': 'Quantitative changes \\& before/after imagery from intraoral scans'}, {'measure': 'Patient-reported experiences', 'timeFrame': 'Baseline, 3 weeks, 12 weeks, 24 weeks', 'description': 'Changes in participant-reported experience as determined through participant-questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingivitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to prove whether a fluoride/zinc lactate containing mouthrinse is able to reduce dental plaque and gingival inflammation in patients who have gingivitis when applied twice daily during brushing at home over a period of 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\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 1.5 as determined by the use of the Gingival Index (Löe 1967).\n* Initial plaque index of at least 1.5 as determined by the use of the Plaque Index (Turesky et al. 1970).\n* Signed Informed Consent Form.\n\nExclusion Criteria:\n\n* Presence of orthodontic bands.\n* Malign tumor(s) of the soft or hard tissues of the oral cavity.\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* Self-reported pregnant or lactating subjects.\n* Participants who have systemic diseases that require regular systemic medication intake that may affect the gingival condition (e.g. antibiotics, phenytoin, nifedipine, cyclosporine, steroids, antiphlogistics).\n* Participants who require antibiotic treatments for dental appointments.\n* Participants with current moderate or severe chronic or aggressive periodontitis (periodontitis screening index \\[PSI\\] \\>2 in more than 2 sextants or PSI \\>3).\n* Subjects with caries requiring treatment (e.g., caries with cavity) or other oral diseases (including gingival hyperplasia, diseases of the oral mucosa);\n* Smokers or/and users of tobacco products.\n* Persons, who are unable to give their consent (e.g., persons who have limited legal capacity)'}, 'identificationModule': {'nctId': 'NCT06048627', 'briefTitle': 'Anti-gingivitis Mouthrinse', 'organization': {'class': 'INDUSTRY', 'fullName': 'Colgate Palmolive'}, 'officialTitle': 'Clinical Investigation to Assess the Efficacy of an Antimicrobial Mouthrinse in the Reduction of Established Plaque and Gingivitis: a 6-month Clinical Study', 'orgStudyIdInfo': {'id': 'CRO-2022-10-MER-MW-JG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mouthwash Test', 'interventionNames': ['Drug: Amine/zinc lactate/fluoride system']}, {'type': 'EXPERIMENTAL', 'label': 'Mouthwash Experimental', 'interventionNames': ['Drug: negative control']}], 'interventions': [{'name': 'Amine/zinc lactate/fluoride system', 'type': 'DRUG', 'description': 'Amine/zinc lactate/fluoride system (250 ppm F), meridol®, Colgate-Palmolive', 'armGroupLabels': ['Mouthwash Test']}, {'name': 'negative control', 'type': 'DRUG', 'description': 'Sodium fluoride mouthwash 250 ppm', 'armGroupLabels': ['Mouthwash Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Technische Universität Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Colgate Palmolive', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}