Connective Tissue Graft From Tuberosity Area and L-PRF Associated With Coronally Advanced Flap for Root Coverage

Not Applicable

Completed

• Conditions: Gingival Recession

• Registration Number: NCT05783258
• Lead Sponsor: G. d'Annunzio University

Brief Summary

The aim of the present randomized controlled clinical study is to compare the efficacy of subepithelial connective tissue graft harvested from the maxillary retromolar tubeosity area and L-PRF membranes in the treatment of RT1 recessions by coronally advanced flap.

A total of 30 patients will be recruited and randomly assigned to the test group treated with CAF+tSCTG or the control group treated with (CAF+L-PRF). For each experimental site the parameters of gingival recession (GR), pocket depth (PD), clinical attachment level (CAL), keratinized gingiva width (KT) and gingival thickness (GT) will be analyzed at baseline (T0) and at 12 months after the surgical procedure (T1). In addition, was also evaluated the different morbidity of the two surgical techniques, using the VAS scale values recorded in the first 2 weeks following surgery. It was checked the Patient Related Esthetic Score and Dentine hypersensivite reduction.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-13
• Study First Submitted: 2023-03-13
• Study First Submitted QC: 2023-03-13
• Study First Posted: 2023-03-24
• Primary Completion: 2023-10-29
• Study Completion: 2023-10-29
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-17
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Presence of a class RT1 recession;
• age > 18 years;
• systemic health conditions that do not affect the periodontium;
• Non smoker;
• FMPS and FMBS values < 20% before the surgical procedure;
• absence of implants or subgingival restorations in the sites to be treated;
• presence of adequate tissue distal to the last maxillary molar.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Gingival thickness	12 months	Gingival tissue thickness 2 mm apical to the recession

Secondary Outcome Measures

Name	Time	Method
Pocket depth	12 months	Distance between gingival margin and bottom of the pocket
Clinical attachment level	12 months	Distance between cementoenamel junction(CEJ) and depth of the pocket
Keratinized tissue height	12 months	Distance between gingival margin and Mucogingival Junction
Gingival recession	12 months	Distance from cementoenamel junction and gingival margin
Complete root coverage	12 months	Percentage of experimental sites that achieved complete root surface coverage.

Trial Locations

Locations (1)

Michele Paolantonio; 🇮🇹 Pescara, Italy