Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2026-02-01 @ 3:00 PM
Study NCT ID:
NCT02774967
Status:
COMPLETED
Last Update Posted:
2016-05-20
First Post:
2016-05-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparation Between Two Surgical Techniques With Acellular Dermal Matrix in Treatment of Gingival Recessions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005889', 'term': 'Gingival Recession'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-19', 'studyFirstSubmitDate': '2016-05-13', 'studyFirstSubmitQcDate': '2016-05-13', 'lastUpdatePostDateStruct': {'date': '2016-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparing changes for Root coverage measure (in millimeter) from baseline at 6 months', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['root coverage', 'gingival recession', 'periodontal surgery'], 'conditions': ['Gingival Recession', 'Gingival Diseases', 'Mouth Diseases', 'Periodontal Atrophy', 'Periodontal Diseases', 'Stomatognathic Diseases']}, 'descriptionModule': {'briefSummary': 'The gold standard for the treatment of gingival recession, is the coronal repositioning of the flap associated with the subepithelial connective tissue graft. The acellular dermal matrix (ADM) has been used as a substitute a subepithelial connective tissue graft in periodontal plastic surgery and mucogengivais, and has achieved similar results. The use of ADM has the advantage of avoiding possible pre and postoperative complications, as well as overcome the limitations presented by autograft. The different surgical techniques used for root coverage seek predictability and success. For this, besides the type of incision placements flap and graft are of utmost importance because the healing benefit and outcome.\n\nThe aim of this study is to compare two surgical techniques for root coverage and evaluate which one provides better cosmetic results and less morbidity . 20 adults , nonsmoking patients , showing multiple bilateral gingival recessions , class I or II Miller located in canine, first and second premolars are selected. Both techniques use the ADM as a graft. However , in one Quadrant partial flap will be held together with relaxing incisions through an incision intrasucular , ADM will be positioned 1 mm apical to the cementoenamel junction (CEJ) and the flap will be positioned 1 mm coronal CEJ. In the opposite quadrant a minimally invasive technique periosteal envelope above does not use relaxing incisions , preserves the buds will be held , as well as avoiding any scars, the graft will be used to ADM. The clinical parameters (probing depth, clinical attachment level, bleeding on probing index, height and width of the gingival retraction and height and thickness of keratinized gingiva) will be evaluated 2 weeks after the basic periodontal therapy and after 6 and 12 months to surgical procedures. In addition, measurements of photographic gingival recession with the aid of software will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nages 18 to 50 years old bilateral multiple gingival recession type Miller class I or II with at least one tooth with 3 mm in height and less than 3mm of keratinized tissue in canine and pre-molar teeth\n\nExclusion Criteria:\n\ndiabetics pregnant women chronic use of medication periodontitis smokings'}, 'identificationModule': {'nctId': 'NCT02774967', 'briefTitle': 'Comparation Between Two Surgical Techniques With Acellular Dermal Matrix in Treatment of Gingival Recessions', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Comparation Between Two Surgical Techniques With Acellular Dermal Matrix in Treatment of Gingival Recessions', 'orgStudyIdInfo': {'id': '35907314.8.0000.5419'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'extended flap technique', 'description': 'root coverage comparing two techniques The aim of this study was to compare and show the benefits of the extended flap technique compared to Tunnel technique both techniques using the acellular dermal matrix for root coverage.\n\nOther Names:\n\nacellular dermal matrix extended flap technique', 'interventionNames': ['Procedure: root coverage']}, {'type': 'EXPERIMENTAL', 'label': 'tunnel technique', 'description': 'root coverage comparing two techniques The aim of this study was to compare and show the benefits of the extended flap technique compared to Tunnel technique both techniques using the acellular dermal matrix for root coverage.\n\nOther Names:\n\nacellular dermal matrix extended flap technique', 'interventionNames': ['Procedure: root coverage']}], 'interventions': [{'name': 'root coverage', 'type': 'PROCEDURE', 'description': 'Root coverage with acellular dermal matrix using two techniques: advanced positional flap ou tunneling,', 'armGroupLabels': ['extended flap technique', 'tunnel technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14098561', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Gabriel F Bastos', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}], 'overallOfficials': [{'name': 'arthur b novaes jr, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FORP-USP'}, {'name': 'gabriel f bastos, MSD Student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FORP-USP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor of periodontics department', 'investigatorFullName': 'Arthur Belem Novaes Jr', 'investigatorAffiliation': 'University of Sao Paulo'}}}}