Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2026-04-21 @ 5:02 PM
Study NCT ID:
NCT02412358
Status:
COMPLETED
Last Update Posted:
2020-01-07
First Post:
2015-04-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Comparision of Three Types of Toothbrushes Pulsar, Crossaction and Butler on Gingivitis and Plaque Removal
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-05', 'studyFirstSubmitDate': '2015-04-06', 'studyFirstSubmitQcDate': '2015-04-08', 'lastUpdatePostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plaque Index', 'timeFrame': '2 weeks', 'description': 'it is an index used for scoring plaque accumulation'}, {'measure': 'Gingival index', 'timeFrame': '2 weeks', 'description': 'it is an index used for scoring gingival inflammation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['toothbrushing', 'plaque control', 'gingivitis'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': "* Objective: To compare clinical results of three types of manual tooth brushes on gingivitis and plaque removal efficacy.\n* Material and Methods: This study is a single blind randomized trial with crossover design which involved 30 periodontally healthy individuals. At baseline professional plaque removal and oral hygiene instruction are performed for all the students, then they are asked to avoid brushing for 1-2 days. Thereafter plaque and gingivitis scores are measured using plaque and gingival indices (PI and GI). Then subjects are instructed to use Pulsar tooth brush for a two-week period and then, GI and PI indices are assessed again. After passing one-week period for wash out, subjects don't brush for 1-2 days and indices are recorded again. The same procedure are done for Cross action, and Butler 411 tooth brushes respectively.", 'detailedDescription': "This study is a single blind randomized trial with crossover design which involved 30 periodontally healthy individuals. At baseline professional plaque removal and oral hygiene instruction are performed for all the students, then they are asked to avoid brushing for 1-2 days. Thereafter plaque and gingivitis scores are measured using plaque and gingival indices (PI and GI). Then subjects are instructed to use Pulsar tooth brush for a two-week period and then, GI and PI indices are assessed again. After passing one-week period for wash out, subjects don't brush for 1-2 days and indices are recorded again. The same procedure are done for Cross action, and Butler 411 tooth brushes respectively."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '24 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* having at least five teeth in each quadrant;\n* no partial denture;\n* no orthodontic banding or retention wires;\n* no oral lesions or sites with probing pockets depth ≥ 5 mm;\n* routine use of a manual toothbrush.\n\nExclusion Criteria:\n\n* having any systematic disease which would influence the course of periodontal diseases or the response to the treatment\n* smoking'}, 'identificationModule': {'nctId': 'NCT02412358', 'briefTitle': 'Clinical Comparision of Three Types of Toothbrushes Pulsar, Crossaction and Butler on Gingivitis and Plaque Removal', 'organization': {'class': 'OTHER', 'fullName': 'Mashhad University of Medical Sciences'}, 'officialTitle': 'Clinical Comparison of Three Types of Toothbrushes Pulsar, Crossaction and Butler on Gingivitis and Plaque Removal', 'orgStudyIdInfo': {'id': '86394'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pulsar', 'description': 'Patients use Pulsar toothbrush for plaque removal', 'interventionNames': ['Device: toothbrush']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Crossaction', 'description': 'Patients use Crossaction toothbrush for plaque removal', 'interventionNames': ['Device: toothbrush']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Butler', 'description': 'Patients use Butler toothbrush for plaque removal', 'interventionNames': ['Device: toothbrush']}], 'interventions': [{'name': 'toothbrush', 'type': 'DEVICE', 'otherNames': ['Pulsar, Crossaction, Butler toothbrush'], 'armGroupLabels': ['Butler', 'Crossaction', 'Pulsar']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91735-984', 'city': 'Mashhad', 'state': 'Khorasan Razavi', 'country': 'Iran', 'facility': 'Amir Moeintaghavi', 'geoPoint': {'lat': 36.29807, 'lon': 59.60567}}], 'overallOfficials': [{'name': 'Amir Moeintaghavi, DDs., Msc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mashhad University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mashhad University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Periodontics', 'investigatorFullName': 'Amir Moeintaghavi', 'investigatorAffiliation': 'Mashhad University of Medical Sciences'}}}}