Tunneled coronally advanced flap versus Modified coronally advanced flap in combination with amnion membrane for the treatment of multiple gingival recession – A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- recession depth
研究概览
简要总结
Gingival recession can arise from various predisposing and precipitating factors, as noted by Hall in 1984. Effective management of gingival recession involves not only eliminating these factors but also repositioning the gingiva to its original position. Numerous surgical methods have been developed, combining various grafting materials—such as autologous, allogenic, or xenogeneic—and surgical designs like flaps and tunneling procedures. The two most commonly used methods are the coronally advanced flap (CAF) and the tunnel technique (TUN). In 2022, Barootchi et al. introduced an innovative approach that combines CAF and TUN, termed the Tunneled Coronally Advanced Flap (TCAF). This technique, when combined with connective tissue graft (CTG), was suggested to be effective for treating isolated RT2 gingival recessions, potentially enhancing flap blood supply, graft vascularization, and patient-reported outcomes, along with clinical and aesthetic improvements.Despite the advantages of connective tissue transplantation for gingival recession, the scarcity of grafts and the need for a secondary surgical site limit its utility. Consequently, guided tissue regeneration (GTR) using allograft membranes has been employed, showing promising results. Human placental membranes, like amnion and chorion, have been used successfully in medicine for healing burns and ulcerated skin disorders, owing to their unique biological properties that promote wound healing and may encourage regeneration. These membranes also have anti-adhesive effects, are bacteriostatic, provide wound protection, reduce pain, and aid epithelialization, making them suitable for GTR in dental applications. This study aimed to compare the efficacy of modified coronally advanced flaps (MCAF) and tunneled coronally advanced flaps (TCAF), both combined with amnion membrane, in treating gingival recessions.
A parallel-mouth randomized controlled trial was conducted with ten patients (five men and five women) aged between 38 and 45, presenting with 34 gingival recession defects. Participants were randomly assigned to either the test group (TCAF) or the control group (MCAF), each consisting of five patients. The test group underwent the tunneled coronally advanced flap procedure with an amnion membrane for treating RT1 and RT2 gingival recessions, while the control group underwent the modified coronally advanced flap technique with an amnion membrane for similar conditions. Inclusion criteria required patients to be 18 years or older, have esthetic concerns or hypersensitivity due to gingival recession, and be systemically healthy. Exclusion criteria included uncontrolled systemic diseases, smoking, active periodontal disease, medications affecting soft tissue healing, allergies to the biomaterials used, and pregnancy or lactation.
Patients received nonsurgical therapy, including scaling and root planing, followed by oral hygiene instructions. Clinical parameters such as probing depth (PPD), gingival recession width (GRW), width of keratinized tissue (WKT), and gingival tissue (GT) were measured at baseline and six months by a masked examiner. A "root coverage esthetic score" (RES) was used to evaluate aesthetic outcomes. For the surgical procedures, the control group underwent a split-full-split thickness flap without vertical releasing incisions, and the amnion membrane was placed over the root surfaces before advancing the flap coronally. The test group involved a vertical incision, creation of a split-full-split thickness flap, and tunneling to place the amnion membrane within the flap, secured with sutures.
Post-surgical care included prescribing antibiotics and using chlorhexidine mouthwash, with oral hygiene instructions and suture removal after 14 days. Clinical indicators were re-measured at three and six months, and patient satisfaction was assessed using the visual analogue scale (VAS) at baseline and six months. Statistical analysis, conducted using SPSS software, involved paired t-tests for intragroup comparisons and unpaired t-tests for intergroup comparisons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with esthetic concern or hypersensitivity associated with GR,
- •Age ≥ 18 years, Systemically healthy and willing to sign consent form and agreeing to participate in the study
- •Presence of RT1 or RT2 multiple adjacent GRs,
- •At least 1.5 mm of keratinized tissue width (KTW) around the included teeth.
排除标准
- •Subjects with an uncontrolled systemic disease (e.g., diabetes, etc.),
- •Presence of active periodontal disease,
- •Individuals taking medications, which could interfere with the healing of the soft tissues,
- •Known allergy to any of the biomaterials to be used.
- •Pregnant and lactating.
结局指标
主要结局
recession depth
时间窗: Baseline | 3 months | 6 months
recession width
时间窗: Baseline | 3 months | 6 months
probing depth
时间窗: Baseline | 3 months | 6 months
gingival thickness
时间窗: Baseline | 3 months | 6 months
clinical attachment level
时间窗: Baseline | 3 months | 6 months
Keratinized tissue width
时间窗: Baseline | 3 months | 6 months
Mean Root Coverage
时间窗: Baseline | 3 months | 6 months
Complete Root Coverage
时间窗: Baseline | 3 months | 6 months
Root coverage esthetic score
时间窗: Baseline | 3 months | 6 months
次要结局
- PROM Patient Reported Outcome Measures(3 and 6 months)
研究者
Pragya Atray
Manipal College of Dental Sciences, Mangalore, Karnataka
