Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT05783258
Status:
COMPLETED
Last Update Posted:
2023-11-21
First Post:
2023-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Connective Tissue Graft From Tuberosity Area and L-PRF Associated With Coronally Advanced Flap for Root Coverage
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': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-10-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-17', 'studyFirstSubmitDate': '2023-03-13', 'studyFirstSubmitQcDate': '2023-03-13', 'lastUpdatePostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gingival thickness', 'timeFrame': '12 months', 'description': 'Gingival tissue thickness 2 mm apical to the recession'}], 'secondaryOutcomes': [{'measure': 'Keratinized tissue height', 'timeFrame': '12 months', 'description': 'Distance between gingival margin and Mucogingival Junction'}, {'measure': 'Gingival recession', 'timeFrame': '12 months', 'description': 'Distance from cementoenamel junction and gingival margin'}, {'measure': 'Complete root coverage', 'timeFrame': '12 months', 'description': 'Percentage of experimental sites that achieved complete root surface coverage.'}, {'measure': 'Clinical attachment level', 'timeFrame': '12 months', 'description': 'Distance between cementoenamel junction(CEJ) and depth of the pocket'}, {'measure': 'Pocket depth', 'timeFrame': '12 months', 'description': 'Distance between gingival margin and bottom of the pocket'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Root coverage', 'Periodontal plastic surgery'], 'conditions': ['Gingival Recession']}, 'descriptionModule': {'briefSummary': 'The aim of the present randomized controlled clinical study is to compare the efficacy of subepithelial connective tissue graft harvested from the maxillary retromolar tubeosity area and L-PRF membranes in the treatment of RT1 recessions by coronally advanced flap.\n\nA total of 30 patients will be recruited and randomly assigned to the test group treated with CAF+tSCTG or the control group treated with (CAF+L-PRF). For each experimental site the parameters of gingival recession (GR), pocket depth (PD), clinical attachment level (CAL), keratinized gingiva width (KT) and gingival thickness (GT) will be analyzed at baseline (T0) and at 12 months after the surgical procedure (T1). In addition, was also evaluated the different morbidity of the two surgical techniques, using the VAS scale values recorded in the first 2 weeks following surgery. It was checked the Patient Related Esthetic Score and Dentine hypersensivite reduction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of a class RT1 recession;\n* age \\> 18 years;\n* systemic health conditions that do not affect the periodontium;\n* Non smoker;\n* FMPS and FMBS values \\< 20% before the surgical procedure;\n* absence of implants or subgingival restorations in the sites to be treated;\n* presence of adequate tissue distal to the last maxillary molar.'}, 'identificationModule': {'nctId': 'NCT05783258', 'briefTitle': 'Connective Tissue Graft From Tuberosity Area and L-PRF Associated With Coronally Advanced Flap for Root Coverage', 'organization': {'class': 'OTHER', 'fullName': "G. d'Annunzio University"}, 'officialTitle': 'Comparative Evaluation of the Coronally Advanced Flap (CAF) Using a Connective Tissue Graft From the Tuberosity (tCTG) or L-PRF Membranes: a Randomized Controlled Clinical Trial.', 'orgStudyIdInfo': {'id': '13032023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAF+tSCTG', 'description': '15 sites will be treated.The extent of the depth of the recession will be reported on the anatomical papillae and, after adding 1 mm, 2 horizontal incisions of approximately 3 mm will be made at the base of the surgical papillae laterally to the recession.Two divergent releasing incisions will be made extending approximately 2-3 mm into the alveolar mucosa.The surgical papillae will be detached in partial thickness. A full thickness dissection will be performed from the bottom of the recession to expose approximately 3mm of the crest bone.A partial thickness dissection will be performed in the most apical portion of the flap until complete passivation of the flap is obtained.The harvesting of the epithelial-connective graft will be performed at the level of the maxillary tuberosity. The de-epithelialised graft will be sutured at the level of the de-epithelialised anatomical papillae.The flap will be repositioned coronally suturing the anatomical papillae on the surgical ones.', 'interventionNames': ['Procedure: Periodontal surgery with CAF+tSCTG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CAF+L-PRF', 'description': '15 sites will be treated.The extent of the depth of the recession will be reported on the anatomical papillae and, after adding 1 mm,2 horizontal incisions of approximately 3 mm will be made at the base of the surgical papillae laterally to the recession. Two divergent releasing incisions will be made extending approximately 2-3 mm into the alveolar mucosa. The surgical papillae will be detached in partial thickness. A full thickness dissection will be performed from the bottom of the recession to expose approximately 3mm of bone.A partial thickness dissection will be performed in the apical portion of the flap to obtain complete passivation.The L-PRF membranes will be realized centrifuged venous blood collected in two 10-ml sterile tubes at 3000 rpm for 10 minutes and squeezing the fibrin clot. L-PRF membranes will be superimposed to crete a double layer of about 2 mm thickness.The flap will be repositioned coronally suturing the anatomical papillae on the surgical ones.', 'interventionNames': ['Procedure: Periodontal surgery with CAF+L-PRF']}], 'interventions': [{'name': 'Periodontal surgery with CAF+tSCTG', 'type': 'PROCEDURE', 'description': 'Coronally advanced flap and subepithelial connective tissue graft harvested from the maxillary tuberosity area.', 'armGroupLabels': ['CAF+tSCTG']}, {'name': 'Periodontal surgery with CAF+L-PRF', 'type': 'PROCEDURE', 'description': 'Coronally advanced flap and L-PRF membranes', 'armGroupLabels': ['CAF+L-PRF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65121', 'city': 'Pescara', 'country': 'Italy', 'facility': 'Michele Paolantonio', 'geoPoint': {'lat': 42.4584, 'lon': 14.20283}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "G. d'Annunzio University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full time professor', 'investigatorFullName': 'Michele Paolantonio', 'investigatorAffiliation': "G. d'Annunzio University"}}}}