A Randomized Controlled Clinical Trial to Evaluate Safety and Effectiveness of CAF + Mucograft® Compared to CAF Alone in Patients With Gingival Recessions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- percentage of root coverage
研究概览
简要总结
The purpose of this multi-center study is to determine the efficacy and safety of Mucograft® in combination with the coronally advanced flap (CAF) for the treatment of gingival recessions. It is assumed that the CAF combined with Mucograft® will result in improved outcome in terms percentage of root coverage and soft tissue thickness in comparison to CAF alone (control).
详细描述
Primary goals of mucogingival surgery have changed with time from maintaining gingival health and prevent further progression of the recession to providing predictable root coverage solving patients' esthetic demands.
Many surgical techniques have been utilized to restore gingival tissue dimensions including the use of autologous soft tissue graft. Longitudinal studies have shown that procedures using pedicle and free grafts are both effective for this purpose. However, since this technique uses epithelialized grafts, it generally results in compromised aesthetics ("patch-like area"). Alternatively free connective tissue grafts (CTG) are used providing similar predictability but resulting in better colour matching. Unfortunately, both techniques are associated with significant patient morbidity due to the wound at the palatal donor site. To avoid patient morbidity, acellular dermal allografts have been used as substitutes for palatal donor tissue, demonstrating the possible and promising use of allograft material. However, since the allograft material is derived from human cadavers; it is associated with ethical concerns and the risk of disease transmission.
In patients with a residual amount of keratinized tissue, the coronally advanced flap (CAF) - first introduce by Norber et al. (1926) - has been demonstrated to be very effective in treatment of multiple and single recessions with advantages in terms of aesthetics and morbidity. Although CAF is a safe and predictable approach for root coverage, the application of this surgical technique in conjunction with autologous or synthetic material was reported to enhance the probability to achieve complete root coverage in Miller Class I and II gingival recessions. A promising option to avoid patient morbidity and the use of autologous transplants or allografts is the use of collagen matrices from porcine origin, such as Mucograft®. Similar devices have been extensively used for guided tissue regeneration procedures. Mucograft® provides an ideal matrix for blood vessel and soft tissue ingrowth, which is likely to improve the results and the predictability of recession coverage procedure using the CAF.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient (male or female) must be 18 years or older
- •The patient must be a candidate for bilateral root coverage procedure
- •Recession defects are Miller Class I-II and do not vary more than 2 mm.
- •At least one mm keratinized tissue is present.
- •Patient shows sufficient plaque control (FMPS < 20%).
- •If patient is of child-bearing potential, the patient confirms not to be pregnant and agrees to take contraception for at least 6 months after surgery.
- •The patient is able to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures
- •The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent.
排除标准
- •Patient is a heavy smoker (> 10 cigarettes per day)
- •Patient is an insulin dependent diabetic
- •General contraindications for dental and/or surgical treatment are present.
- •The patient has a history of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years.
- •The patient is pregnant or nursing
- •The patient is taking medications or having treatments which have an effect on mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs).
- •The patient has a disease, which affects connective tissue metabolism (e.g. collagenases).
- •The patient is allergic to collagen.
- •Patients have participated in a clinical trial within the last six months.
研究组 & 干预措施
Mucograft + CAF
Mucograft in combination with coronally advanced flap (CAF)
干预措施: Mucograft (Device)
CAF
Coronally advanced flap (CAF) alone
干预措施: Coronally advanced flap (CAF) (Procedure)
结局指标
主要结局
percentage of root coverage
时间窗: 6 month
次要结局
- gingival thickness(6 month)
