Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2026-02-23 @ 11:34 AM
Study NCT ID:
NCT01814592
Status:
UNKNOWN
Last Update Posted:
2013-03-26
First Post:
2013-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Two Coronally Positioned Flap With Connective Tissue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005889', 'term': 'Gingival Recession'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}], 'ancestors': [{'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-03-23', 'studyFirstSubmitDate': '2013-03-11', 'studyFirstSubmitQcDate': '2013-03-15', 'lastUpdatePostDateStruct': {'date': '2013-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assess the frequency of adverse events', 'timeFrame': '0 hours (intrasurgical), 1-24 hours (immediate postoperative), 25 hours to 6 days (mediate postoperative) and 7 or more days (late postoperative)'}], 'primaryOutcomes': [{'measure': 'Assess percentage of total root coverage between two subepithelial conective tissue graft technique for covering Class I and II Miller recessions patients attending at dental clinics of "Universidad El Bosque"', 'timeFrame': 'one month (plus or minus 2 days), three months (plus or minus 3 days) and six months (plus or minus 5 days)'}], 'secondaryOutcomes': [{'measure': 'Assess the proportion of root coverage', 'timeFrame': 'one month (plus or minus 2 days), Three months (plus or minus 3 days) and six month (plus or minus 5 days)'}, {'measure': 'Clinical attachment level, width of keratinized tissue and the position of the mucogingival junction following root coverage procedures', 'timeFrame': 'one month (plus or minus 2 days), three months (plus or minus 3 days) and six months (plus or minus 5 days)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['coronally positioned flap', 'connective tissue', 'gingival margin', 'gingival recession/ treatment', 'gingival recession/ surgery', 'subepithelial connective tissue graft', 'randomized controlled clinical trial', 'surgical flaps', 'Treatment outcome'], 'conditions': ['Gingival Recession', 'Periodontal Atrophy']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effectiveness of total root coverage between two coronally positioned flap technique in Miller recession Class I and II, in patients attending at "Universidad El Bosque" dental school clinics.', 'detailedDescription': 'This is a blind, randomized controlled clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Class I and II Miller recessions showing a recession depth ≥ 2 mm.\n* Recessions isolated and / or maximum continuous two teeth.\n* Recessions in incisors, canines and premolars\n* Patients 20 to 60 years old.\n\nExclusion Criteria:\n\n* Systemic compromise, that contraindicates any periodontal surgical procedure.\n\n * Warfarin medication.\n * Uncontrolled diabetes mellitus with glycosylated hemoglobin ≥ 8\n * Chronic steroid therapy (dose of 7.5 mg/ day for more than 14 days)\n * HIV-AIDS infection with CD4 counts \\<200.\n * Immunosuppression.\n* Recessions molars not be taken into account in the study.\n* Patients who have used antibiotics one month prior to the surgical procedure.\n* Pregnancy.\n* Active smoker.\n* Patients with a history of periodontal surgery at the recession area that has taken place in the last three months.\n* Severe dental malposition, teeth rotation, versions teeth root coverage that contraindicates surgery.\n* Non carious cervical lesions or caries where is not visible the cemento- enamel junction (CEJ).\n* Active inflammation that contraindicates surgical procedure of the recession.\n* Active Orthodontics'}, 'identificationModule': {'nctId': 'NCT01814592', 'briefTitle': 'Comparison Between Two Coronally Positioned Flap With Connective Tissue', 'organization': {'class': 'OTHER', 'fullName': 'Universidad El Bosque, Bogotá'}, 'officialTitle': 'Comparison of Two Bilaminar Techniques for Root Covering of Miller´s Recessions Class I and II: A Blind, Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'PCI-2012-359'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'coronally mucosal thickness flap', 'description': 'coronally mucosal thickness flap plus connective tissue graft for root coverage (subepithelial connective tissue graft)', 'interventionNames': ['Procedure: coronally mucosal thickness flap']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'coronally partial thickness flap', 'description': 'coronally partial thickness flap plus connective tissue for root coverage (subepithelial connective tissue graft)', 'interventionNames': ['Procedure: coronally partial thickness flap plus connective tissue']}], 'interventions': [{'name': 'coronally partial thickness flap plus connective tissue', 'type': 'PROCEDURE', 'otherNames': ['subepithelial connective tissue graft', 'coronally positioned flap'], 'description': 'The design of the flap will be performed according to the technique described by de Sanctis and Zucchelli 2007.', 'armGroupLabels': ['coronally partial thickness flap']}, {'name': 'coronally mucosal thickness flap', 'type': 'PROCEDURE', 'otherNames': ['superficial-layer split-tihickness flap'], 'description': 'The design of the flap will be performed according to the technique described by Greenwell H, Vance G, Munninger B and Johnston H.', 'armGroupLabels': ['coronally mucosal thickness flap']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110121', 'city': 'Bogotá, D. C.', 'state': 'Bogotá, D. C.', 'country': 'Colombia', 'facility': 'Universidad El Bosque', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}], 'overallOfficials': [{'name': 'Sergio I Losada Amaya, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad El bosque- UNIECLO'}, {'name': 'Jaime A Marquez Cristo, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Universidad El Bosque- UNIECLO'}, {'name': 'Miguel F Vargas del Campo, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Universidad El Bosque- UNIECLO'}, {'name': 'Silie S Arboleda Salaiman, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Universidad El Bosque- UNIECLO'}, {'name': 'Maria I Pardo Silva, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad El Bosque- UNIECLO'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad El Bosque, Bogotá', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, DDS, specialist in periodontics and oral medicine', 'investigatorFullName': 'Sergio Iván Losada Amaya', 'investigatorAffiliation': 'Universidad El Bosque, Bogotá'}}}}