Clinical Evaluation of Tunneled Coronally Advanced Flap (TCAF) Versus Coronally Advanced Flap (CAF) Combined With Connective Tissue Graft in the Treatment of Isolated RT2 Gingival Recession Sites: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Gingival Recession Depth
研究概览
简要总结
The goal of this clinical trial is to evaluate gingival recession depth reduction using tunneled coronally advanced flap compared to coronally advanced flap, both combined with connective tissue graft in patients with isolated RT2 gingival recession sites.
详细描述
Gingival recession can cause clinical conditions that could be of main concern for patients. Techniques aiming for coverage of the gingival recession aim to address dentin hypersensitivity, non-carious cervical lesions (NCCLs) and enhance patient's esthetics (Cortellini & Bissada, 2018). Mid-buccal gingival recessions have been associated with patient's esthetic discomfort (Zucchelli & Mounssif, 2015). Most of the studies in the literature focus on the treatment of RT1 recession as they have the most favorable prognosis of full root coverage (Barootchi et al., 2020). Despite most studies focusing their attention on RT1 cases, RT2 defects are found to be the most prevalent type with 88.8% among patients according to (Romandini et al., 2020).
The coronally advanced flap and the tunneling technique are the most commonly performed surgical approaches for treating gingival recessions. However, these two approaches have commonly been regarded as alternatives to each other, with clinicians choosing to perform only one of them during root coverage procedures.
(Barootchi & Tavelli, 2022) aimed in his conducted case series to designate a surgical technique to treat isolated RT2 gingival recession defects in which he was trying to achieve and combine the advantage of both better access and graft stabilization in CAF and the preservation of the integrity of the papilla and better blood supply to the graft present in tunneling technique. The study concluded that the combination of both techniques in the same surgical design can have the potential to enhance flap and graft vascularization and improve clinical, esthetic, and patient-reported outcomes. To our knowledge, there is no conducted randomized clinical trials comparing the tunneled coronally advanced flap technique to the coronally advanced flap for gingival depth reduction.
So, this clinical trial aims to address this gap of the literature.
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
Single blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients age 18 years or older.
- •Isolated recession defect classified as RT
- •Patients with healthy systemic condition.
- •Clinical indication and/or patient request for root coverage.
- •O'Leary index less than 20%.
排除标准
- •Pregnant females
- •Smokers: a contraindication for any plastic periodontal surgery.
- •Unmotivated and uncooperative patients with poor oral hygiene
- •Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or parafunctional habits.
研究组 & 干预措施
Tunneled coronal advanced flap with connective tissue graft
TCAF involves the elevation of one trapezoidal surgical papilla at the papilla with less interproximal clinical attachment loss, by a slightly divergent vertical incision extending beyond the mucogingival junction is done then a horizontal incision at a distance equal to the recession depth plus 1 mm apical to the papilla tip just as the conventional coronally advanced flap (CAF). Then a tunneling knife will be used to perform the intra-sulcular incision on the treated site and on the tooth adjacent to the papilla that will be preserved for tension-free flap advancement.
The midfacial aspect of the tooth will be elevated with tunneling knives while the surgical papilla will be elevated in a split-thickness manner.
. The anatomical papilla will be de-epithelialized, either with a surgical blade or micro scissors, while the other papilla will be gently mobilized with a tunneling instrument. .
The harvested connective tissue graft will be inserted underneath the flap
干预措施: Tunneled coronal advanced flap with connective tissue graft (Procedure)
Coronally advanced flap with connective tissue graft
A trapezoidal-shaped flap will be elevated with a split-full-split approach in the coronal-apical direction:
- The surgical papillae will be elevated by split thickness keeping the blade almost parallel to the root.
- The soft tissue apical to the root exposure will be elevated in a full thickness manner to expose 3-4mm of bone apical to the bone dehiscence. This was done to include the periosteum in the thickness of that central portion of the flap covering the avascular root exposure.
- The releasing vertical incisions will be elevated by split thickness keeping the blade parallel to the bone thus leaving the periosteum to protect the underlying bone in the lateral areas of the flap.
- The part of the flap apical to bone exposure will be elevated by split-thickness, this step will be done so it is possible to move the flap passively in the coronal direction.
The harvested connective tissue graft will be inserted underneath the flap
干预措施: Coronally advanced flap with connective tissue graft (Procedure)
结局指标
主要结局
Gingival Recession Depth
时间窗: 6 months
It's measured as the distance between cemento-enamel junction (CEJ), and gingival margin (GM) using periodontal probe.
次要结局
- Percentage of mean root coverage (MRC%)(6 months)
- Gingival Thickness(6 months)
- Pink Esthetic Score(6 months)
- Percentage of complete root coverage (CRC%)(6 months)
- Clinical Attachment Level(6 months)
- Post-operative patient satisfaction(2 weeks, 6 months)
- Gingival Recession Width(6 months)
- Keratinized Tissue Width(6 months)
- Post-operative pain(2 weeks)
- Probing Pocket Depth(6 months)
- Root coverage esthetic score(6 months)
研究者
Omar Hazem Mohamed Said Sallam
Teaching Assistant
Cairo University