Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT05436002
Status:
UNKNOWN
Last Update Posted:
2022-06-28
First Post:
2022-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Buccal Ginvigal Recessions With the Tunnel Technique in Conjunction With Cross-linked Hyaluronic Acid and Subepithelial Connective Tissue Graft. A Randomized Clinical Trial
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2024-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-22', 'studyFirstSubmitDate': '2022-06-22', 'studyFirstSubmitQcDate': '2022-06-22', 'lastUpdatePostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gingival margin', 'timeFrame': '6 month after surgery', 'description': 'Score 0: failure of root coverage (gingival margin apical or equal to the baseline recession); Score 3: partial root coverage; Score 6: complete root coverage with no detectable CEJ.'}, {'measure': 'Marginal tissue contour', 'timeFrame': '6 month after surgery', 'description': 'Score 0: irregular gingival margin (it does not follow CEJ); Score 1: proper marginal contour/scalloped gingival margin (following CEJ).'}, {'measure': 'Soft tissue texture', 'timeFrame': '6 month after surgery', 'description': 'Score 0: presence of scar formation and/or keloid-like appearance; Score 1: absence of scar or keloid formation.'}, {'measure': 'Mucogingival junction', 'timeFrame': '6 month after surgery', 'description': 'Score 0: MGJ not aligned with MGJ on adjacent teeth; Score 1: MGJ aligned with MGJ on adjacent teeth.'}, {'measure': 'Gingival color', 'timeFrame': '6 month after surgery', 'description': 'Score 0: color of tissue differs from gingival color on adjacent teeth; Score 1: normal color and integration with the adjacent soft tissues.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cross-linked hyaluronic acid', 'tunnel technique', 'gingival recession'], 'conditions': ['Cross-linked Hyaluronic Acid']}, 'descriptionModule': {'briefSummary': 'To evaluate the outcomes of buccal gengival recession type 1 (RT1) treated with the tunnel technique in conjunction with a cross-linked hyaluronic acid and subepithelial palatal connective tissue grafts.', 'detailedDescription': 'To evaluate the outcomes of buccal gengival recession type 1 (RT1) treated with the tunnel technique in conjunction with a cross-linked hyaluronic acid and subepithelial palatal connective tissue grafts.\n\nTo evaluate the esthetic outcome as perceived by periodontists, using the root coverage esthetic score (RES).\n\nTest Group - Tunnel technique in conjunction with a cross-linked hyaluronic acid and subepithelial palatal connective tissue grafts.\n\nControl Group - Tunnel technique and subepithelial palatal connective tissue grafts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* None of the patients were smokers and all were systemically healthy without any signs of periodontal disease.\n* Each patient had to display at least one ginvigal recession (RT1) of a depth of ≥ 2 mm.\n* Patients exhibited an adequate level of oral hygiene evidenced by a full- mouth plaque score (FMPS) \\< 25%39 and full-mouth bleeding score (FMBS) \\< 25%.\n\nExclusion Criteria:\n\n* Smokers\n* Gingival recesstion RT 2 or RT 3 (Cairo 2011).'}, 'identificationModule': {'nctId': 'NCT05436002', 'briefTitle': 'Treatment of Buccal Ginvigal Recessions With the Tunnel Technique in Conjunction With Cross-linked Hyaluronic Acid and Subepithelial Connective Tissue Graft. A Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Lisbon'}, 'officialTitle': 'Treatment of Buccal Ginvigal Recessions With the Tunnel Technique in Conjunction With Cross-linked Hyaluronic Acid and Subepithelial Connective Tissue Graft. A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Cross-linked hyaluronic acid'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'With Cross-linked Hyaluronic Acid', 'description': 'Tunnel Technique in Conjunction With Cross-linked Hyaluronic Acid and Subepithelial Connective Tissue Graft.', 'interventionNames': ['Device: With Cross-linked Hyaluronic Acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Whitout Cross-linked Hyaluronic Acid', 'description': 'Tunnel Technique in Conjunction With Subepithelial Connective Tissue Graft.', 'interventionNames': ['Device: With Cross-linked Hyaluronic Acid']}], 'interventions': [{'name': 'With Cross-linked Hyaluronic Acid', 'type': 'DEVICE', 'description': 'Without Cross-linked Hyaluronic Acid', 'armGroupLabels': ['Whitout Cross-linked Hyaluronic Acid', 'With Cross-linked Hyaluronic Acid']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Vanessa Rodrigues, Dr', 'role': 'CONTACT', 'email': 'Vanessa_15_rodrigues@hotmail.com', 'phone': '919950890', 'phoneExt': '+351'}], 'overallOfficials': [{'name': 'Vanessa Rodrigues, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Lisbon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lisbon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dra', 'investigatorFullName': 'Vanessa Rocha Rodrigues', 'investigatorAffiliation': 'University of Lisbon'}}}}