Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2026-01-01 @ 2:28 AM
Study NCT ID:
NCT05821712
Status:
COMPLETED
Last Update Posted:
2023-04-20
First Post:
2023-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A New Mouthwash on Reducing Dental Plaque and Helping Prevent Gum Problems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058225', 'term': 'Plaque, Amyloid'}, {'id': 'D005882', 'term': 'Gingival Diseases'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-07', 'studyFirstSubmitDate': '2023-03-27', 'studyFirstSubmitQcDate': '2023-04-07', 'lastUpdatePostDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gingival inflammation', 'timeFrame': 'baseline', 'description': 'Loe-Silness Gingival Index'}, {'measure': 'Gingival inflammation', 'timeFrame': '3 months', 'description': 'Loe-Silness Gingival Index'}, {'measure': 'Gingival inflammation', 'timeFrame': '6 months', 'description': 'Loe-Silness Gingival Index'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Plaque', 'Gum Disease']}, 'referencesModule': {'references': [{'pmid': '38217757', 'type': 'DERIVED', 'citation': 'Montesani L, Montesani L, Mateo L, Daep C, Huber N, Isapour G, Zhang YP. Antibacterial and clinical effectiveness of a mouthwash with a novel active system of amine + zinc lactate + fluoride: a randomized controlled trial. Clin Oral Investig. 2024 Jan 13;28(1):90. doi: 10.1007/s00784-023-05487-0.'}]}, 'descriptionModule': {'briefSummary': 'This 6-month clinical study was designed to investigate clinical efficacy on plaque and gingivitis for the Meridol Base Mouthwash containing 0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride as compared to a Negative Control Mouthwash containing 0.057% sodium fluoride after 3 and 6 months of product use.'}, '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* Initial gingivitis index of at least 1.0 as determined by the use of the Loe-Silness Gingival Index.\n* Initial plaque index of at least 1.5 as determined by the use of the Quigley-Hein Plaque Index.\n* Signed Informed Consent Form\n\nExclusion Criteria:\n\n* Presence of orthodontic bands.\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* Self-reported pregnant or lactating subjects'}, 'identificationModule': {'nctId': 'NCT05821712', 'briefTitle': 'A New Mouthwash on Reducing Dental Plaque and Helping Prevent Gum Problems', 'organization': {'class': 'INDUSTRY', 'fullName': 'Colgate Palmolive'}, 'officialTitle': 'Investigation of Clinical Efficacy of a New Mouthwash on Reducing Dental Plaque and Helping Prevent Gum Problems as Compared to a Control Mouthwash - a Six-month Study in Italy', 'orgStudyIdInfo': {'id': 'CRO-2020-12-PGN-MMW-ITA-YPZ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash', 'description': 'mouthwash', 'interventionNames': ['Drug: 0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash']}, {'type': 'ACTIVE_COMPARATOR', 'label': '0.057% sodium fluoride Mouthwash', 'description': 'mouthwash', 'interventionNames': ['Drug: 0.057% sodium fluoride Mouthwash']}], 'interventions': [{'name': '0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash', 'type': 'DRUG', 'description': 'mouthwash', 'armGroupLabels': ['0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash']}, {'name': '0.057% sodium fluoride Mouthwash', 'type': 'DRUG', 'description': 'mouthwash', 'armGroupLabels': ['0.057% sodium fluoride Mouthwash']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00187', 'city': 'Roma', 'state': 'Rome', 'country': 'Italy', 'facility': 'Clinica Odontoiatrica Montesani', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'overallOfficials': [{'name': 'Luigi Montesani, MD, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinica Odontoiatrica Montesani'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Colgate Palmolive', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}