Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-27 @ 11:12 PM
Study NCT ID:
NCT03862534
Status:
COMPLETED
Last Update Posted:
2025-03-27
First Post:
2019-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CAF With or Without CTG for the Treatment of Single Maxillary Gingival Recession With NCCL
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': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2019-02-27', 'studyFirstSubmitQcDate': '2019-03-02', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recession Reduction', 'timeFrame': 'At 12 months', 'description': 'Difference between gingival recession at 12 months and baseline, measured with a periodontal probe.'}, {'measure': 'Complete Root Coverage (CRC)', 'timeFrame': 'At 12 months', 'description': 'Absence or presence of gingival recession at 12 months follow-up.'}], 'secondaryOutcomes': [{'measure': 'Root coverage Esthetic Score (RES)', 'timeFrame': 'At 12 months', 'description': 'Overall esthetic score from 0 to 10 evaluated by the blinded examiner. Higher values represent a better outcome. (Pini-Prato et al. 2011)'}, {'measure': 'Gingival Thickness (GT)', 'timeFrame': 'Baseline - 12 months', 'description': 'Gingival thickness in mm, measured with an endodontic file and a digital caliper.'}, {'measure': 'Keratinized Tissue (KT)', 'timeFrame': 'Baseline - 6 and 12 months', 'description': 'Width of the keratinized gingiva measured in mm from the gingival margin to the muco-gingival-junction using a periodontal probe'}, {'measure': 'KTgain', 'timeFrame': 'At 12 months', 'description': 'Gain of Keratinized Tissue measured as the difference between KT at 12 months and KT baseline'}, {'measure': 'Gingival Recesión (REC)', 'timeFrame': 'Baseline - 6 and 12 months', 'description': 'The distance between the reconstructed cementum enamel junction and the gingival margin measured in mm with a periodontal probe'}, {'measure': 'Root sensitivity', 'timeFrame': 'Baseline - 6 and 12 months', 'description': 'Toot sensitivity reported by the patient present or absent'}, {'measure': 'SensVAS', 'timeFrame': 'Baseline - 6 and 12 months', 'description': 'Toot sensitivity reported by the patient on a 0 to 10 Visual Analogue Scale. Higher values represent worse outcome.'}, {'measure': 'SurTime', 'timeFrame': 'At surgery', 'description': 'Surgical Time in minutes from the end of anesthesia to the sutures'}, {'measure': 'Anti-infammTab', 'timeFrame': '1 week post-surgery', 'description': 'Number of tablets of anti-inflammatory drug taken in the first week post-operatively by the patients.'}, {'measure': 'DiscVAS', 'timeFrame': '1 week post-surgery', 'description': 'Post Operative Discomfort reported by the patients on a 0 to 10 Visual Analogue Scale. Higher values represent worse outcome.'}, {'measure': 'AesthVAS', 'timeFrame': 'At 12 months', 'description': 'Aesthetic overall satisfaction reported by the patients on a 0 to 10 Visual Analogue Scale. Higher values represent better outcomes.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gingival recession', 'Non-carious cervical lesion', 'Connective tissue graft'], 'conditions': ['Gingival Recession']}, 'referencesModule': {'references': [{'pmid': '28758301', 'type': 'BACKGROUND', 'citation': 'Cairo F. Periodontal plastic surgery of gingival recessions at single and multiple teeth. Periodontol 2000. 2017 Oct;75(1):296-316. doi: 10.1111/prd.12186.'}, {'pmid': '27454460', 'type': 'BACKGROUND', 'citation': 'Cairo F, Pagliaro U, Buti J, Baccini M, Graziani F, Tonelli P, Pagavino G, Tonetti MS. Root coverage procedures improve patient aesthetics. A systematic review and Bayesian network meta-analysis. J Clin Periodontol. 2016 Nov;43(11):965-975. doi: 10.1111/jcpe.12603. Epub 2016 Sep 16.'}, {'pmid': '20967303', 'type': 'BACKGROUND', 'citation': 'Cairo F, Pini-Prato GP. A technique to identify and reconstruct the cementoenamel junction level using combined periodontal and restorative treatment of gingival recession. A prospective clinical study. Int J Periodontics Restorative Dent. 2010 Dec;30(6):573-81.'}, {'pmid': '17032103', 'type': 'BACKGROUND', 'citation': 'Hwang D, Wang HL. Flap thickness as a predictor of root coverage: a systematic review. J Periodontol. 2006 Oct;77(10):1625-34. doi: 10.1902/jop.2006.060107.'}, {'pmid': '19046326', 'type': 'BACKGROUND', 'citation': 'Cortellini P, Tonetti M, Baldi C, Francetti L, Rasperini G, Rotundo R, Nieri M, Franceschi D, Labriola A, Prato GP. Does placement of a connective tissue graft improve the outcomes of coronally advanced flap for coverage of single gingival recessions in upper anterior teeth? A multi-centre, randomized, double-blind, clinical trial. J Clin Periodontol. 2009 Jan;36(1):68-79. doi: 10.1111/j.1600-051X.2008.01346.x. Epub 2008 Nov 20.'}, {'pmid': '19419445', 'type': 'BACKGROUND', 'citation': 'Santamaria MP, da Silva Feitosa D, Nociti FH Jr, Casati MZ, Sallum AW, Sallum EA. Cervical restoration and the amount of soft tissue coverage achieved by coronally advanced flap: a 2-year follow-up randomized-controlled clinical trial. J Clin Periodontol. 2009 May;36(5):434-41. doi: 10.1111/j.1600-051X.2009.01389.x.'}, {'pmid': '21542735', 'type': 'BACKGROUND', 'citation': 'Zucchelli G, Gori G, Mele M, Stefanini M, Mazzotti C, Marzadori M, Montebugnoli L, De Sanctis M. Non-carious cervical lesions associated with gingival recessions: a decision-making process. J Periodontol. 2011 Dec;82(12):1713-24. doi: 10.1902/jop.2011.110080. Epub 2011 May 4.'}]}, 'descriptionModule': {'briefSummary': 'This studies evaluate the efficacy of the coronally advanced flap (CAF) with or without connective tissue graft (CTG) for the treatment of single maxillary recession associated to non carious cervical lesion (NCCL).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* No systemic diseases or pregnancy.\n* Self-reported smoking ≤ 10 cigarettes/day.\n* Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤ 10% (measured at four sites per tooth).\n* Presence of single RT1 buccal gingival recessions ≥ 2 mm of depth located in the anterior area of the upper jaw (central and lateral incisors, canine, first and second pre-molars, first molar) and associated with aesthetic complains and or dental sensitivity.\n* Presence of NCCL associated with recession\n* No history of mucogingival or periodontal surgery at experimental sites.\n\nExclusion Criteria:\n\n* Prosthetic crown at experimental teeth.\n* Gingival recessions presenting minimal amount (\\< 1mm) of apico-coronal keratinized tissue (KT) extension apical to recession area.'}, 'identificationModule': {'nctId': 'NCT03862534', 'briefTitle': 'CAF With or Without CTG for the Treatment of Single Maxillary Gingival Recession With NCCL', 'organization': {'class': 'OTHER', 'fullName': 'University of Florence'}, 'officialTitle': 'Coronally Advanced Flap (CAF) and Composite Restoration of the Enamel With or Without Connective Tissue Graft (CTG) for the Treatment of Single Maxillary Gingival Recession With Non-carious Cervical Lesion (NCCL). A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'RCT restored CEJ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAF', 'description': 'After the restoration of the enamel patients were treated with a CAF', 'interventionNames': ['Procedure: CAF']}, {'type': 'EXPERIMENTAL', 'label': 'CAF + CTG', 'description': 'After the restoration of the enamel patients were treated with a CAF + CTG', 'interventionNames': ['Procedure: CAF + CTG']}], 'interventions': [{'name': 'CAF', 'type': 'PROCEDURE', 'description': 'After the cementum enamel junction (CEJ) was restorated, a split thickness flap was raised, coronally advanced and sutured to cover the recession', 'armGroupLabels': ['CAF']}, {'name': 'CAF + CTG', 'type': 'PROCEDURE', 'description': 'After the cementum enamel junction (CEJ) was restorated, a split thickness flap was raised. Then a connective tissue graft was harvested from the palate and sutured over the exposed root. Finally the flap was coronally advanced and sutured to cover the recession', 'armGroupLabels': ['CAF + CTG']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Francesco Cairo, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florence'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florence', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Roma La Sapienza', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head, Research Unit in Periodontology and Periodontal Medicine', 'investigatorFullName': 'Dr. Francesco Cairo', 'investigatorAffiliation': 'University of Florence'}}}}