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

Coronally Advanced Flap With and Without Connective Tissue Graft for the Treatment of Single Maxillary Gingival Recession With Loss of Inter-dental Attachment. A Randomized Controlled Clinical Trial - 10 Years Results

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.

Study Overview

• Status: Completed
• Conditions: Gingival Recession
• Intervention / Treatment: Other: CAF+CTG; Other: CAF

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Tuscany
    • Florence, Tuscany, Italy, 50100
      • University of Florence

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: CAF+CTG; Coronally Advanced Flap + Connective Tissue Graft
Active Comparator: 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	Other: CAF; Coronally Advanced Flap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Root Coverage (CRC)	Complete Root Coverage: absence of gingival recession (Yes/No)	After the intervention (10 years)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Florence

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 15, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2022
• Last Update Submitted That Met QC Criteria: October 3, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: RT2-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No