V-CAF Technique for Miller Class III Gingival Recession

N/AActive Not RecruitingNCT07788443

University of Medicine and Pharmacy at Ho Chi Minh City25 enrolled

Overview

The purpose of this clinical trial is to evaluate the effectiveness of a modified surgical technique called the vertically coronally advanced flap (V-CAF) combined with a connective tissue graft and tissue regeneration for treating gingival recession. For more severe cases (Miller Class III), the study investigates the relationship between the pre-operative Coronally Advanced Flap Difficulty Score (CAFDS) and post-operative outcomes, such as the root coverage rate and interdental papilla height. Participants will undergo the assigned surgical treatment and will be followed up at 3, 6, and 12 months to assess healing and tissue stability.

Gingival recession is a condition that causes root exposure, which can lead to dentin hypersensitivity and aesthetic concerns. Initially, the study describes the clinical characteristics and factors associated with gingival recession utilizing clinical examinations, 3D intraoral scans, and Cone Beam Computed Tomography (CBCT). The interventional surgical phase is the single-arm clinical trial involving Twenty-five Miller Class III gingival recession sites. This phase evaluates the correlation between the pre-operative Coronally Advanced Flap Difficulty Score (CAFDS) and clinical outcomes, specifically evaluating the root coverage percentage and interdental papilla height using the V-CAF technique. Standardized clinical parameters, including Recession Depth (RD), Keratinized Tissue (KT) height, Gingival Thickness (GT), Vestibular Depth (RVD), and the Root Coverage Esthetic Score (RES) will be recorded. Data will be collected at baseline (T0), 3 months (T3), 6 months (T6), and 12 months (T12) post-surgery to conduct comparative analyses.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged 18 years or older * Systemically healthy (no systemic diseases) and not pregnant * Non-smokers * Presence of at least one tooth presenting with Miller Class III gingival recession with a recession depth of ≥ 2 mm * Medium or thin gingival biotype Exclusion Criteria: * History of periodontal treatment or mucogingival/periodontal surgery at the study site * Presence of fixed prosthesis on the tooth with gingival recession * Teeth with rotation or crowding * Presence of occlusal trauma * Active or progressive periodontitis * Patients who fail to attend follow-up visits or demonstrate non-compliance with post-operative care instructions

Outcomes

Primary Outcomes

Mean Root Coverage (MRC)

The mean percentage of root surface coverage achieved following treatment, assessed by measuring the root coverage area on intraoral scan files using digital measurement software

Time frame: Baseline, 3 months, and 6 months after surgery

Coronally Advanced Flap Difficulty Score (CAFDS)

The Coronally Advanced Flap Difficulty Score (CAFDS) will be used to assess the anatomical difficulty of treating gingival recession defects with a coronally advanced flap. The score consists of eight anatomical parameters: papilla anatomy, apical keratinized tissue width, lateral keratinized tissue width, apical frenum, lateral frenum, vestibular depth, mucosal invagination, and scar tissue. Each parameter is assessed and assigned a predefined score according to the CAFDS system, with higher scores indicating greater surgical difficulty.

Time frame: Baseline (T0), before surgery