Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2026-03-01 @ 6:11 AM
Study NCT ID:
NCT06594757
Status:
COMPLETED
Last Update Posted:
2025-01-28
First Post:
2024-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plaque Removal by Triple-Headed Manual Toothbrush
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014099', 'term': 'Toothbrushing'}], 'ancestors': [{'id': 'D009910', 'term': 'Oral Hygiene'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2024-09-09', 'studyFirstSubmitQcDate': '2024-09-11', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rustogi Modifiye Navy Plaque Index', 'timeFrame': '1 minute before brushing', 'description': 'The amount of plaque present on the teeth was assessed using a plaque staining agent and graded according to the plaque index system. Higher scores mean a worse outcome.'}, {'measure': 'Rustogi Modifiye Navy Plaque Index', 'timeFrame': '1 minute after brushing', 'description': 'The amount of plaque present on the teeth was assessed using a plaque staining agent and graded according to the plaque index system. Higher scores mean a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oral hygiene', 'Rustogi Modifiye Navy Plaque Index', 'Modified Bass Technique', 'toothbrush', 'dental plaque'], 'conditions': ['Plaque, Dental']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial aimed to determine the effectiveness of a plaque removal by triple-headed manual toothbrush by comparing changes in Rustogi Modifiye Navy Plaque Index.\n\nParticipants will be divided into two groups and will be made to brush with different designed toothbrushes.\n\nThe researchers will compare the plaque removal efficiency of the brushes by comparing the changes in the plaque index of the intervention and control groups before and after brushing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ranging from 18-60 years;\n* a minimum of 12 teeth;\n* participants were wanted to be right-handers when toothbrushing to standardization.\n\nExclusion Criteria:\n\n* Patients with systemic illnesses or conditions,\n* smokers and individuals taking any medication that may affect periodontal health were not included in the study.\n* Individuals who had previously been treated for periodontal disease in the past 6 months were also excluded.'}, 'identificationModule': {'nctId': 'NCT06594757', 'briefTitle': 'Plaque Removal by Triple-Headed Manual Toothbrush', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'Evaluation of Plaque Removal by Triple-Headed Manual Toothbrush: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'TSA-2023-13318'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standart Manual Toothbrush (SMB)', 'description': 'Conventional toothbrushing with standart manual toothbrush', 'interventionNames': ['Procedure: Toothbrushing with standard manual toothbrush']}, {'type': 'EXPERIMENTAL', 'label': 'Triple-Headed Manual Toothbrush (3HB)', 'description': 'Toothbrushing with triple-headed manual toothbrush', 'interventionNames': ['Procedure: Toothbrushing with triple-headed manual toothbrush']}], 'interventions': [{'name': 'Toothbrushing with triple-headed manual toothbrush', 'type': 'PROCEDURE', 'description': 'Toothbrushing with triple-headed manual toothbrush', 'armGroupLabels': ['Triple-Headed Manual Toothbrush (3HB)']}, {'name': 'Toothbrushing with standard manual toothbrush', 'type': 'PROCEDURE', 'description': 'Toothbrushing with tstandard manual toothbrush', 'armGroupLabels': ['Standart Manual Toothbrush (SMB)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25240_', 'city': 'Erzurum', 'country': 'Turkey (Türkiye)', 'facility': 'Atatürk University', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}], 'overallOfficials': [{'name': 'Didem Özkal Eminoğlu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ataturk University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Didem OZKAL EMINOGLU', 'investigatorAffiliation': 'Ataturk University'}}}}