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

Not Applicable

Completed

• Conditions: Gingival Recession
• Interventions: Other: CAF; Other: CAF+CTG

• 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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAF	CAF	After local anaesthesia, a split-full-split thickness flap was elevated. The papillae adjacent to the involved tooth were then de-epithelialized. A gentle root debridement was performed. The flap was coronally displaced 1-2 mm above the CEJ and sutured
CAF+CTG	CAF+CTG	After local anaesthesia, a split-full-split thickness flap was elevated. The papillae adjacent to the involved tooth were then de-epithelialized. A gentle root debridement was performed. A 1-2-mm-thick CTG was harvested using a single incision approach from the palate in the area between the second pre-molar and the second molar. The wound on the donor site of the palate was then sutured. The graft was positioned on the instrumented root surface immediately apical or at the level of the CEJ and then stabilized using a compressive crossing suture, anchored to the periosteum apical to the graft and closed with a palatal knot. The flap was coronally displaced 1-2 mm above the CEJ and sutured

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