Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2026-03-04 @ 8:18 PM
Study NCT ID:
NCT02534220
Status:
COMPLETED
Last Update Posted:
2015-08-27
First Post:
2015-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Manual Versus Oscillating-rotating Toothbrushes After Root Coverage Procedure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005889', 'term': 'Gingival Recession'}], 'ancestors': [{'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-26', 'studyFirstSubmitDate': '2015-08-21', 'studyFirstSubmitQcDate': '2015-08-26', 'lastUpdatePostDateStruct': {'date': '2015-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Complete Root Coverage Rate', 'timeFrame': 'Change in Complete Root Coverage Rate at 1 month', 'description': 'Abscence of exposed root surface measured ad percentage'}, {'measure': 'Change in Complete Root Coverage Rate', 'timeFrame': 'Change in Complete Root Coverage Rate at 3 months', 'description': 'Abscence of exposed root surface measured ad percentage'}, {'measure': 'Change in Complete Root Coverage Rate', 'timeFrame': 'Change in Complete Root Coverage Rate at 6 months', 'description': 'Abscence of exposed root surface measured ad percentage'}], 'secondaryOutcomes': [{'measure': 'Change in Recession Depth', 'timeFrame': 'Baseline, 1 month, 3 months, 6 months', 'description': 'Distance from the gingival margin to the cementum-enamel junction, measured in millimeters'}, {'measure': 'Change in Clinical Attachment Level', 'timeFrame': 'Baseline, 1 month, 3 months, 6 months', 'description': 'Distance from the cementum-enamel junction to the bottom of the periodontal Pocket, measured in millimeters'}, {'measure': 'Change in Probing Pocket Depth', 'timeFrame': 'Baseline, 1 month, 3 months, 6 months', 'description': 'Distance from the gingival margin to the bottom of the periodontal pocket, measured in millimeters'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Toothbrushing', 'Oral hygiene', 'Dental hygiene'], 'conditions': ['Gingival Recession']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the gingival margin stability with the use of oscillating-rotating toothbrushes compared to manual toothbrushes.', 'detailedDescription': "BACKGROUND Oscillating-rotating power toothbrushes have been proven clinically efficacious. To the investigators' knowledge, a clinical evaluation of the safety of these toothbrushes after surgical root coverage procedure have not been published. The aim of this study is to evaluate the gingival margin stability with the use of oscillating-rotating toothbrushes compared to manual toothbrushes.\n\nMETHODS Sixty healthy patients with at least a single Miller Class I or II gingival recession underwent surgical root coverage procedure. Soft-bristle manual and powered toothbrushes were given to participants randomly assigned to control and test group, respectively. Full-mouth plaque score, Full-mouth Bleeding Score, Probing Pocket Depth and Recession Depth were recorded 1, 3 and 6 months after completion of surgical procedure. Longitudinal analyses were performed using linear random-intercept models to take into account within-subject correlations over time. Temporal trend differences across treatments by including treatment-time interaction terms were then tested using a global Wald test."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Full-Mouth Plaque Score (FMPS) ≤25%\n* Full-Mouth Bleeding Score (FMBS) ≤25%\n* Miller Class I and II buccal recession ≥2 mm\n\nExclusion Criteria:\n\n* Relevant systemic condition or disease\n* Smokers\n* Teeth with prosthetic crowns or restorations in the cervical area\n* Presence of pulling frenum in the keratinized tissue\n* Previous mucogingival or periodontal surgery in the experimental site'}, 'identificationModule': {'nctId': 'NCT02534220', 'briefTitle': 'Manual Versus Oscillating-rotating Toothbrushes After Root Coverage Procedure', 'organization': {'class': 'OTHER', 'fullName': 'University of Milan'}, 'officialTitle': 'Gingival Margin Stability After Mucogingival Plastic Surgery. The Effect of Manual Versus Powered Toothbrushing: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Oral-B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Manual Toothbrush', 'description': 'Patients were instructed in the Roll Brushing Technique, twice daily for 2 min.', 'interventionNames': ['Device: Manual Toothbrush']}, {'type': 'EXPERIMENTAL', 'label': 'Oscillating-rotating toothbrush', 'description': "Patients received manufacturer's instructions for use, including brushing twice daily for 2 min.", 'interventionNames': ['Device: Oscillating-rotating toothbrush']}], 'interventions': [{'name': 'Manual Toothbrush', 'type': 'DEVICE', 'description': 'Gum Delicate Post-Surgical Toothbrush, Oral-B, Procter \\& Gamble, Cincinnati, OH', 'armGroupLabels': ['Manual Toothbrush']}, {'name': 'Oscillating-rotating toothbrush', 'type': 'DEVICE', 'description': 'Triumph 5000, Oral-B, Procter \\& Gamble, Cincinnati, OH', 'armGroupLabels': ['Oscillating-rotating toothbrush']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Clinica Odontoiatrica IRCCS Ospedale Maggiore Policlinico', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Giulio Rasperini', 'role': 'STUDY_DIRECTOR', 'affiliation': "Unit of Periodontology, Department of Biomedical, Surgical and Dental Sciences, University of Milan, Foundation IRCCS Ca' Granda Policlinic"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Giulio Rasperini', 'investigatorAffiliation': 'University of Milan'}}}}