Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2026-01-04 @ 5:38 AM
Study NCT ID:
NCT06366568
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2024-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of a Eugenol-based Product to Improve the Quality of Toothbrushing and Relieving Gum Discomfort Areas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003773', 'term': 'Dental Plaque'}], 'ancestors': [{'id': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-15', 'studyFirstSubmitDate': '2024-04-03', 'studyFirstSubmitQcDate': '2024-04-15', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Turesky Modification of the Quigley & Hein Plaque Index', 'timeFrame': 'baseline and six months', 'description': 'Reduction in plaque measurement is served as primary efficacy variable are served. The scoring scheme for the Turesky Modification of the Quigley-Hein dental plaque index is as follows: 0 = no plaque. 1 = separate flecks of plaque at the cervical margin of the tooth. 2 = a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth.'}], 'secondaryOutcomes': [{'measure': 'questionnaire', 'timeFrame': 'six months', 'description': 'self-reported questionnaires are served as secondary efficacy variable.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['plaque gingivitis'], 'conditions': ['Plaque, Dental']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the efficacy of a eugenol-based product in improving the quality of toothbrushing and relieving areas of gingival discomfort. This is a randomized, controlled, parallel, examiner-blind clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* You must provide consent to participate by signing this informed consent form.\n* Available for the two(2) week study duration.\n* You must be at least eighteen(18) years old and not older than seventy(70) years of age.\n* You must not smoke.\n* You must be in good general health for participation in the study, based on the opinion of the study investigator.\n* You must have at least 20 natural permanent teeth.\n* Your teeth must meet the scoring entry criteria for dental plaque and gingivitis(gum inflammation) at the discretion of the study examiner.\n* You must meet the scoring criteria for gum discomfort, determined using your responses to the survey questionnaire.\n* You must have no known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the study examiner.\n\nExclusion Criteria:\n\n* Medical condition which requires premedication prior to dental visits/procedures.\n* Presence of fix/ removable prosthodontics dentures that may interfere with this study clinical examinations.\n* Advanced periodontal disease (gum disease) and/or treatment for periodontal disease (including surgery) within the past twelve months.\n* Five (5) or more decayed, untreated dental sites (cavities) and/or any dental condition requiring urgent dental care.\n\nAbnormalities/diseases of the soft or hard oral tissues.\n\n* Orthodontic appliances/bands/lingual bars that interfere with any clinical assessment (plaque scoring)\n* Current smokers and/or tobacco users and/or a history of alcohol or drug abuse.\n* Use of drugs that can affect salivary flow.\n* Use of antibiotics one (1) month prior to study entry and/or during participation in this study.\n* Use of any over the counter medications other than analgesics that could interfere with the study at PI discretion.\n* Self-reported pregnancy and/or breastfeeding.\n* Current Participation in another clinical study or during the month prior to this clinical study entry.\n* Known allergies and/or reactions to common dentifrice ingredients.\n* Medical condition which prohibits not eating/drinking or chewing gum for four (4) hours prior to your scheduled visits.\n* Immunocompromised conditions (AIDS, immunosuppressive drug therapy).\n* Infectious disease and/or other blood borne diseases (Hepatitis series, HIV, tuberculosis).'}, 'identificationModule': {'nctId': 'NCT06366568', 'briefTitle': 'Efficacy of a Eugenol-based Product to Improve the Quality of Toothbrushing and Relieving Gum Discomfort Areas', 'organization': {'class': 'INDUSTRY', 'fullName': 'Colgate Palmolive'}, 'officialTitle': 'Clinical Investigation to Assess the Efficacy of a Eugenol-based Product in Improving the Quality of Toothbrushing Measured by Plaque Assessment and Patient Perception Questionnaire and Relieving Gum Discomfort Areas', 'orgStudyIdInfo': {'id': 'CRO-2022-10-PG-MER-MW-JG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'toothpaste and gum product, brushing 2x a day for 2 minutes followed by gum product application', 'interventionNames': ['Drug: fluoride toothpaste containing 1450 ppm of MFP in a PCC base and eugenol gum product']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 2', 'description': 'toothpaste , brushing 2x a day for 2 minutes', 'interventionNames': ['Drug: fluoride toothpaste containing 1450 ppm of MFP in a PCC base']}], 'interventions': [{'name': 'fluoride toothpaste containing 1450 ppm of MFP in a PCC base and eugenol gum product', 'type': 'DRUG', 'description': 'PARTICIPANTS WILL USE A EUGENOL BASED product PRIOR TO TOOTHBRUSHING', 'armGroupLabels': ['Group 1']}, {'name': 'fluoride toothpaste containing 1450 ppm of MFP in a PCC base', 'type': 'DRUG', 'description': 'toothbrushing 2x a day for 2 minutes each time', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitätsklinikum Carl Gustav Carus Technische Universität Dresden Department of Periodontology Fetscherstras', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Colgate Palmolive', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}