Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2026-01-01 @ 4:12 AM
Study NCT ID:
NCT02459704
Status:
COMPLETED
Last Update Posted:
2015-10-08
First Post:
2015-05-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Semilunar Coronally Positioned Flap With or Without Enamel Matrix Derivative for the Treatment of Gingival Recessions
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-06', 'studyFirstSubmitDate': '2015-05-25', 'studyFirstSubmitQcDate': '2015-06-01', 'lastUpdatePostDateStruct': {'date': '2015-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Recession Reduction as measured by difference between gingival recession depth', 'timeFrame': 'Baseline, 12 months', 'description': 'Measured as a difference between gingival recession depth at baseline and gingival recession at 6 months follow-up.'}], 'secondaryOutcomes': [{'measure': 'Complete root coverage', 'timeFrame': '12 months', 'description': 'Assessed as percentage of sites with complete root coverage'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Gingival Recession', 'Semilunar flap', 'Enamel matrix derivative', 'Periodontal regeneration'], 'conditions': ['Gingival Recession']}, 'referencesModule': {'references': [{'pmid': '29948276', 'type': 'DERIVED', 'citation': 'Franca-Grohmann IL, Sangiorgio JPM, Bueno MR, Casarin RCV, Silverio KG, Nociti FH Jr, Casati MZ, Sallum EA. Does enamel matrix derivative application improve clinical outcomes after semilunar flap surgery? A randomized clinical trial. Clin Oral Investig. 2019 Feb;23(2):879-887. doi: 10.1007/s00784-018-2506-y. Epub 2018 Jun 12.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study will be evaluate clinically the use of the Semilunar Coronally Positioned Flap (SCPF) for the treatment of gingival recessions, with or without Enamel Matrix Derivative (EMD). Thirty patients will be assigned in two groups. Half of patients will receive EMD associated to SCPF, while the other half, will receive SCPF alone.', 'detailedDescription': 'The aim of this study will be evaluate clinically the use of the Semilunar Coronally Positioned Flap (SCPF) for the treatment of gingival recessions, with or without Enamel Matrix Derivative (EMD). Thirty patients will be selected, randomized and allocated in two groups: test group (SCPF + EMD) and control group (SCPF). The subjects will should present buccal Miller class I gingival recessions with height greater than or equal to 2.0 mm and less than to 4.0 mm in maxillary canines or premolars. Clinical parameters will be evaluated: gingival recession height (GRH), gingival recession width(GRW), clinical attachment level (CAL), probing depth (PD), height (HKT) and thickness (TKT) of keratinized tissue and papillas height (HP) and width(LP), as well as plaque and gingival index. These data will be collected at baseline and 180 days after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Presence of at least one Miller Class I gingival recession ≥ 2 mm or ≤ 4mm in maxillary canines or premolars with identifiable cementum-enamel junction (CEJ);\n* Height of keratinized tissue ≥ 2 mm;\n* Aesthetic complaint and/or presence of dentin hypersensitivity to air stimulus;\n* Full-mouth visible plaque index ≤ 20% (Ainamo \\& Bay 1975);\n* Full-mouth sulcus bleeding index ≤ 20% (Mühlemann \\& Son 1971).\n\nExclusion Criteria:\n\n* Smoking;\n* Pregnancy;\n* Presence of systemic disorders (diabetes, hypertension, heart disease or any other condition that could contraindicate periodontal surgery);\n* Use of medications (immunosuppressants, phenytoin or anything else that might affect mucosal healing and repair);\n* Previous periodontal surgery in the area.'}, 'identificationModule': {'nctId': 'NCT02459704', 'briefTitle': 'Semilunar Coronally Positioned Flap With or Without Enamel Matrix Derivative for the Treatment of Gingival Recessions', 'organization': {'class': 'OTHER', 'fullName': 'University of Campinas, Brazil'}, 'officialTitle': 'Semilunar Coronally Positioned Flap With or Without Enamel Matrix Derivative for the Treatment of Miller Class I Gingival Recessions: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '038/2012'}, 'secondaryIdInfos': [{'id': '2013/13098-9', 'type': 'OTHER_GRANT', 'domain': 'FAPESP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SCPF + EMD (TEST)', 'description': 'Semilunar coronally positioned flap with Enamel matrix derivative (Emdogain)', 'interventionNames': ['Procedure: Semilunar coronally positioned flap', 'Device: Enamel matrix derivative (Emdogain)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SCPF (CONTROL)', 'description': 'Semilunar coronally positioned flap alone', 'interventionNames': ['Procedure: Semilunar coronally positioned flap']}], 'interventions': [{'name': 'Semilunar coronally positioned flap', 'type': 'PROCEDURE', 'description': 'Semilunar coronally positioned flap with enamel matrix derivative (Emdogain) or alone.', 'armGroupLabels': ['SCPF (CONTROL)', 'SCPF + EMD (TEST)']}, {'name': 'Enamel matrix derivative (Emdogain)', 'type': 'DEVICE', 'description': 'Enamel matrix derivative associated to semilunar coronally positioned flap (SCPF + EMD - test group)', 'armGroupLabels': ['SCPF + EMD (TEST)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13414-903', 'city': 'Piracicaba', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Piracicaba Dental School, State University of Campinas', 'geoPoint': {'lat': -22.72528, 'lon': -47.64917}}], 'overallOfficials': [{'name': 'Enilson A Sallum, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Campinas, Brazil'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campinas, Brazil', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, department of Periodontics, Piracicaba Dental School, State University of Campinas (UNICAMP), Piracicaba, São Paulo, Brazil', 'investigatorFullName': 'Enilson Antonio Sallum', 'investigatorAffiliation': 'University of Campinas, Brazil'}}}}