Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for the Treatment of Miller Class I Gingival Recession: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Mean Root Coverage (MRC)
研究概览
简要总结
This randomized controlled clinical trial aims to compare the clinical effectiveness of the Vertically Coronally Advanced Flap (VCAF) and the Coronally Advanced Flap (CAF), both combined with connective tissue graft (CTG) and enamel matrix derivative (EMD), for the treatment of Miller Class I gingival recession. Twenty-six Miller Class I gingival recession defects will be randomly assigned in a 1:1 ratio to either the VCAF + CTG + EMD group or the CAF + CTG + EMD group. Clinical outcomes, including mean root coverage, complete root coverage, recession depth, recession width, probing depth, clinical attachment level, keratinized tissue width, gingival thickness, vestibular depth, and esthetic outcomes, will be assessed at baseline and throughout a 6-month follow-up period. Three-dimensional digital models obtained from an intraoral scanner will also be used to evaluate soft tissue changes following treatment. The study is designed to determine whether the VCAF technique provides superior clinical and esthetic outcomes compared with the conventional CAF technique.
详细描述
Gingival recession is a common mucogingival condition that may result in dentin hypersensitivity, root caries, plaque accumulation, and esthetic concerns. Coronally Advanced Flap (CAF) combined with connective tissue graft (CTG) is considered the gold standard for the treatment of localized gingival recession because of its predictable root coverage outcomes. However, coronal advancement of the flap may reduce vestibular depth, potentially affecting oral hygiene practices and long-term soft tissue stability.
The Vertically Coronally Advanced Flap (VCAF) technique has been developed to facilitate coronal flap advancement while preserving vestibular depth. This study compares VCAF and conventional CAF, both combined with CTG and enamel matrix derivative (EMD), to determine whether VCAF can provide comparable or improved root coverage while minimizing changes in vestibular depth and achieving favorable esthetic outcomes.
In addition to conventional clinical assessments, three-dimensional digital intraoral scans will be used to quantify soft tissue changes following surgery, providing a comprehensive evaluation of treatment outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Clinical measurements and digital analyses of intraoral scans will be performed by an independent examiner who is blinded to treatment allocation. The examiner will not participate in the surgical procedures or the randomization process.
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
- •Miller Class I gingival recession.
- •No history of mucogingival or periodontal surgery at the study site.
- •Gingival recession depth ≥ 2 mm.
- •Medium or thin gingival thickness.
排除标准
- •Participants with uncontrolled systemic diseases, such as diabetes mellitus or hypertension, or coagulation disorders.
- •Participants who do not attend follow-up visits or do not comply with the postoperative care instructions.
研究组 & 干预措施
Control Group (CAF + CTG + EMD)
Participants assigned to the control group will receive root coverage surgery using the conventional Coronally Advanced Flap (CAF) combined with a connective tissue graft (CTG) and enamel matrix derivative (EMD).
干预措施: Coronally Advanced Flap (Procedure)
Experimental Group (VCAF + CTG + EMD)
Participants assigned to the experimental group will receive root coverage surgery using the Vertically Coronally Advanced Flap (VCAF) combined with a connective tissue graft (CTG) and enamel matrix derivative (EMD).
干预措施: Vertically Coronally Advanced Flap (Procedure)
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
Vestibular Depth (VD)
时间窗: Baseline, 3 months, and 6 months after surgery
The change in vestibular depth from baseline, measured on intraoral scan files using digital measurement software.
次要结局
- Complete Root Coverage (CRC)(Baseline, 3 months, and 6 months after surgery)
- Recession Depth (RD)(Baseline, 3 months, and 6 months after surgery)
- Recession Width (RW)(Baseline, 3 months, and 6 months after surgery)
- Keratinized Tissue Width (KTW)(Baseline, 3 months, and 6 months after surgery)
- Gingival Thickness (GT)(Baseline, 3 months, and 6 months after surgery)
- Root Esthetic Score (RES)(3 months, and 6 months after surgery)
研究者
Nguyen Thu Thuy
Associate Professor
University of Medicine and Pharmacy at Ho Chi Minh City