Evaluating the V-CAF Technique in Miller Class III Gingival Recession and the Correlation Between Coronally Advanced Flap Difficulty Score and Root Coverage Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
- 主要终点
- Mean Root Coverage (MRC)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Clinical measurements and digital analyses of intraoral scans will be performed by an independent examiner who will not participate in the surgical procedures.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Mean Root Coverage (MRC)
时间窗: Baseline, 3 months, and 6 months after surgery
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
Coronally Advanced Flap Difficulty Score (CAFDS)
时间窗: Baseline (T0), before surgery
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.
次要结局
- Base of the Interdental Papilla (IPb)(Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12))
- Gingival Recession Depth (RD)(Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12))
- Gingival Recession Width (RW)(Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12))
- Interdental Papilla Height (IPh)(Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12))
- Interdental Papilla Width (IPw)(Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12))
- Keratinized Tissue Height (KT)(Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12))
- Gingival Thickness (GT)(Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12))
- Vestibular Depth (RVD)(Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12))
- Root Coverage Esthetic Score (RES)(3 months, 6 months, and 12 months post-operative (T3, T6, T12))
- Area of Gingival Recession(Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12))
研究者
Nguyen Thu Thuy
Associate Professor
University of Medicine and Pharmacy at Ho Chi Minh City