Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-01-07 @ 7:41 PM
Study NCT ID:
NCT05472233
Status:
COMPLETED
Last Update Posted:
2025-07-24
First Post:
2022-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Suturing Protocols on Coronally Advanced Flap for Root Coverage Outcomes
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Retrospective cohort study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-20', 'studyFirstSubmitDate': '2022-07-21', 'studyFirstSubmitQcDate': '2022-07-21', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Root Coverage', 'timeFrame': '6 months', 'description': 'Achievement of 100% root coverage, measured as yes / no'}, {'measure': 'Mean Root Coverage', 'timeFrame': '6 months', 'description': 'Percentage of the root recession that has been successfully covered after the surgical procedure'}], 'secondaryOutcomes': [{'measure': 'Patient discomfort', 'timeFrame': 'at suture removal', 'description': 'Discomfort reported by the patient (present/absent)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gingival recession', 'Sutures', 'Root coverage', 'Healing'], 'conditions': ['Gingival Recession']}, 'referencesModule': {'references': [{'pmid': '26447751', 'type': 'BACKGROUND', 'citation': 'Tatakis DN, Chambrone L. The Effect of Suturing Protocols on Coronally Advanced Flap Root-Coverage Outcomes: A Meta-Analysis. J Periodontol. 2016 Feb;87(2):148-55. doi: 10.1902/jop.2015.150394. Epub 2015 Oct 8.'}, {'pmid': '30151706', 'type': 'BACKGROUND', 'citation': 'Tavelli L, Barootchi S, Ravida A, Suarez-Lopez Del Amo F, Rasperini G, Wang HL. Influence of suturing technique on marginal flap stability following coronally advanced flap: a cadaver study. Clin Oral Investig. 2019 Apr;23(4):1641-1651. doi: 10.1007/s00784-018-2597-5. Epub 2018 Aug 27.'}, {'pmid': '17726994', 'type': 'BACKGROUND', 'citation': 'Huang LH, Wang HL. Sling and tag suturing technique for coronally advanced flap. Int J Periodontics Restorative Dent. 2007 Aug;27(4):379-85.'}, {'pmid': '16253095', 'type': 'BACKGROUND', 'citation': 'Huang LH, Neiva RE, Wang HL. Factors affecting the outcomes of coronally advanced flap root coverage procedure. J Periodontol. 2005 Oct;76(10):1729-34. doi: 10.1902/jop.2005.76.10.1729.'}, {'pmid': '25315018', 'type': 'BACKGROUND', 'citation': 'Tatakis DN, Chambrone L, Allen EP, Langer B, McGuire MK, Richardson CR, Zabalegui I, Zadeh HH. Periodontal soft tissue root coverage procedures: a consensus report from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S52-5. doi: 10.1902/jop.2015.140376. Epub 2014 Oct 15.'}, {'pmid': '21859324', 'type': 'BACKGROUND', 'citation': 'Chambrone L, Pannuti CM, Tu YK, Chambrone LA. Evidence-based periodontal plastic surgery. II. An individual data meta-analysis for evaluating factors in achieving complete root coverage. J Periodontol. 2012 Apr;83(4):477-90. doi: 10.1902/jop.2011.110382. Epub 2011 Aug 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this retrospective study is to investigate whether suturing protocols (suture removal timing) influence root coverage outcomes in recession defects treated with a coronally advanced flap (CAF) procedure.', 'detailedDescription': "The aim of this study is to assess whether the timing of suture removal may influence the number of sites exhibiting complete coverage (CRC) or the mean root coverage (MRC) obtained in single-tooth recession-type defects treated by coronally advanced flap (CAF).\n\nRecords from patients that underwent a coronally advanced flap (CAF) procedure for root coverage will be analyzed. This surgical procedure is aimed at the treatment of root recessions that may arise following periodontal disease or mechanical trauma. The procedure, after obtaining deep local anesthesia, involves a sulcular incision on the buccal side and extending the incision mesially and distally to the base of the adjacent papillae. Two vertical incisions are then made at the corner of the adjacent tooth line and extended into the alveolar mucosa. A mixed thickness flap is then elevated and coronally advanced by releasing incisions through the periosteum to allow for flap placement to cover the recession without tension. The papillae are de-epithelized to provide the bed of connective tissue for the adaptation of the flap which is then sutured with single stitches.\n\nThe records, complete with photographic documentation, of all patients who have undergone this procedure will be identified and will be divided into two groups: those in which the sutures were removed at 2 weeks and those in which the sutures were removed at 3 or more weeks.\n\nCRC as present or absent (yes/no) and MRC (percentage of roof surface that has been successfully covered) six months after surgery will be assessed in these patients.\n\nThe presence of patient discomfort on the day of suture removal will be recorded as present / absent to assess whether the permanence of the sutures for longer or shorter influences the patient's perception of the surgery.\n\nThe results will be compared between the two groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients not affected by active periodontitis\n* Single recessions on non-restored non-molar teeth\n* CAF protocols using vertical releasing incisions\n* records of patients clearly reporting timing of suture removals and root coverage outcomes at 6 months\n\nExclusion Criteria:\n\n* Adjacent recessions\n* Recessions on molar teeth\n* Coronally advanced flaps without releasing incisions\n* Patients with active periodontitis'}, 'identificationModule': {'nctId': 'NCT05472233', 'briefTitle': 'Effect of Suturing Protocols on Coronally Advanced Flap for Root Coverage Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University of Cagliari'}, 'officialTitle': 'The Effect of Sutures Removal Protocols on Coronally Advanced Flap for Root Coverage Outcomes: a Retrospective Study', 'orgStudyIdInfo': {'id': 'Perio1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '2weeks', 'description': 'Suture removal at 2 weeks post intervention', 'interventionNames': ['Procedure: Suture removal after Coronally Positioned Flap']}, {'type': 'EXPERIMENTAL', 'label': '3+weeks', 'description': 'Suture removal at 3 weeks minimum post intervention', 'interventionNames': ['Procedure: Suture removal after Coronally Positioned Flap']}], 'interventions': [{'name': 'Suture removal after Coronally Positioned Flap', 'type': 'PROCEDURE', 'description': 'Sutures are removed after different healing period post coronally positioned flap surgery, this latter is a procedure that aims at surgically advancing the gingiva in order to cover dehiscences of the soft tissues uncovering dental roots.', 'armGroupLabels': ['2weeks', '3+weeks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09042', 'city': 'Monserrato', 'state': 'CA', 'country': 'Italy', 'facility': 'Policlinico Duilio Casula, AOU Cagliari', 'geoPoint': {'lat': 39.25642, 'lon': 9.1444}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data will be submitted for publication right after the analysis of the outcomes', 'ipdSharing': 'YES', 'description': 'Individual participant data will be shared in a publication after the end of the study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cagliari', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Nicola Alberto Valente, DDS, MS, PhD', 'investigatorAffiliation': 'University of Cagliari'}}}}