Treatment of Single Maxillary Gingival Recession With Loss of Inter-dental Attachment. A Randomized Controlled Clinical Trial

Not Applicable

Completed

• Conditions: Gingival Recession

• Registration Number: NCT05460182
• Lead Sponsor: University of Florence

Brief Summary

Background: The aim of this randomized clinical trial (RCT) was to evaluate the adjunctive benefit of Connective Tissue Graft (CTG) to Coronally Advanced Flap (CAF) for the treatment of gingival recession associated with inter-dental clinical attachment loss equal or smaller to the buccal attachment loss (RT2). Material and Methods:The patients were randomly assigned to CAF+CTG (test group) or to CAF alone (Control group). Measurements were performed by a blind and calibrated examiner. Outcome measures included complete root coverage (CRC), recession reduction (RecRed), Root coverage Esthetic Score (RES), intra-operative and post-operative morbidity, and root sensitivity.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-01
• Primary Completion: 2021-11-01
• Study Completion: 2022-03-01
• Study First Submitted: 2022-07-06
• Study First Submitted QC: 2022-07-11
• Study First Posted: 2022-07-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Smoking < 20 cigarettes/day.
• Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) < 15% (measured at four sites per tooth).
• Presence of at least one RT2 (Cairo et al. 2011) buccal gingival recession > 2 mm of depth
• Only gingival recessions localized at upper central and lateral incisors, canine, and first and second pre-molars associated with aesthetic problems and/ordental hypersensitivity were considered.
• Presence of an identifiable CEJ

Exclusion Criteria

• Systemic diseases or pregnancy.
• Systemic antibiotic therapy in the last 6 months.
• Active periodontal disease with sites showing probing depth >4 mm.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Complete Root Coverage (CRC)	After the intervention (10 years)	Complete Root Coverage: absence of gingival recession (Yes/No)

Secondary Outcome Measures

Name	Time	Method
Recession Reduction (RecRed)	After the intervention (10 years)	Change of the gingival recession, in mm
Root Coverage Aesthetic Score (RES)	After the intervention (10 years)	A scoring system ranging from 0 to 10

Trial Locations

Locations (1)

University of Florence; 🇮🇹 Florence, Tuscany, Italy