Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT05594004
Status:
COMPLETED
Last Update Posted:
2022-10-26
First Post:
2022-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Meta-analysis Comparing Toothbrushes on Plaque Removal and Gingival Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005891', 'term': 'Gingivitis'}, {'id': 'D003773', 'term': 'Dental Plaque'}], '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': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2929}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-21', 'studyFirstSubmitDate': '2022-10-21', 'studyFirstSubmitQcDate': '2022-10-21', 'lastUpdatePostDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Bleeding Sites', 'timeFrame': 'Up to 6 months (26 weeks)', 'description': 'Change from baseline as measured on number of bleeding sites ( via gingival bleeding index, Loe Silness index, Gingival Bleeding Index (GBI), Papillary bleeding index or Mazza gingival index).'}, {'measure': 'Dental Plaque Scores', 'timeFrame': 'Up to 6 months (26 weeks)', 'description': "Change from baseline as measured by mean plaque score reduction from baseline (via Turesky's Modification of Quigley-Hein index, or Rustogi Modified Navy Plaque Index)."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingivitis', 'Dental Plaque']}, 'descriptionModule': {'briefSummary': 'The aim of this analysis was to compare gingivitis- and plaque-reduction efficacy from randomized controlled trials (RCTs) up to six months long evaluating oscillating-rotating, sonic, and manual toothbrushes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This meta-analysis includes healthy adult male and females.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Subjects were excluded from this study for the following reasons;\n\n* pregnancy,\n* rampant caries,\n* severe periodontitis,\n* at discretionary of the Principal Investigator.'}, 'identificationModule': {'nctId': 'NCT05594004', 'briefTitle': 'A Meta-analysis Comparing Toothbrushes on Plaque Removal and Gingival Health', 'organization': {'class': 'INDUSTRY', 'fullName': 'Procter and Gamble'}, 'officialTitle': 'A Meta-analysis Comparing Electric and Manual Toothbrushes on Plaque Removal and Gingival Health', 'orgStudyIdInfo': {'id': '2022BrushMetaAnalysis'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Oscillating-Rotating electric toothbrush', 'description': 'Twice daily brushing', 'interventionNames': ['Device: Oscillating-rotating electric toothbrush']}, {'label': 'Sonic electric toothbrush', 'description': 'Twice daily brushing', 'interventionNames': ['Device: Sonic electric toothbrush']}, {'label': 'Manual toothbrush', 'description': 'Twice daily brushing', 'interventionNames': ['Device: Manual toothbrush']}], 'interventions': [{'name': 'Oscillating-rotating electric toothbrush', 'type': 'DEVICE', 'description': 'Oscillating-rotating electric toothbrush used twice daily', 'armGroupLabels': ['Oscillating-Rotating electric toothbrush']}, {'name': 'Sonic electric toothbrush', 'type': 'DEVICE', 'description': 'Sonic electric toothbrush used twice daily', 'armGroupLabels': ['Sonic electric toothbrush']}, {'name': 'Manual toothbrush', 'type': 'DEVICE', 'description': 'Manual toothbrush used twice daily', 'armGroupLabels': ['Manual toothbrush']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45040', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Multiple Study Locations', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Procter and Gamble', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}