Clinical Applications of 3D Collagen Matrix (Mucograft®) in the Management of Gingival Recession: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in the Clinical Attachment Level Index
研究概览
简要总结
Twenty patients with gingival recession will be enrolled in this trial. Gingival recession will be treated in one side by applying Mucograft® with coronally advanced flap (CAF) while on the opposite side a connective tissue graft (from the palate) will be applied with a CAF.
Patients will be followed for 3 and 6 months by measuring the clinical indexes and statistical analyses will be performed to compare the results and to assess the success of Mucograft®.
详细描述
Many surgical techniques have used to treat gingival recession such aas repositioned flaps, autologous soft tissue grafts (connective tissue graft or free gingival grafts) or allografts like acellular dermal which can be used as substitutes for palatal donor tissue. Mucograft® (3D collagen matrix) is also an allograft from porcine origin and is designed for soft tissue regeneration and considered the ideal solution to autogenous soft tissue grafts and it provides an ideal matrix for blood vessel and soft tissue ingrowth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of Type I or II (Miller Classification) of gingival recession
排除标准
- •Pregnancy or lactating
- •Presence of any systematic diseases can affect the periodontal surgery.
- •Subjects with significant moderate to severe periodontal disease.
- •Patients under orthodontic treatment
- •Presence of restorative materials (e.g. crown)
- •Effectiveness of frenum
- •Subjects have failed to maintain good plaque control.
- •Subjects having previous surgical treatment for covering the recession in the chosen area.
研究组 & 干预措施
Mucograft
One side of the mouth will be subjected to Mucograft in this split-mouth study design.
干预措施: Mucograft (Procedure)
Connective tissue graft
The opposite side of the mouth will be subjected to a connective tissue graft.
干预措施: Connective Tissue Graft (Procedure)
结局指标
主要结局
Change in the Clinical Attachment Level Index
时间窗: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively
Clinical Attachment Level is dependent on measuring the pocket depth as well as the amount of gingival recession using specific tools. The measurement is going to be recorded in millimeters.
次要结局
- Change in Probing Depth(Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively)
- Change in Gingival Recession(Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively)
- Change in Gingival Biotype(Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively)
- Change in Root Coverage Index(Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively)
- Change in Resistance to Muscular Pull(Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively)
- Change in Color Match Index(Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively)
- Shrinkage index at three months(Measurements will be done at two time points to calculate the amount of shrinkage :(1) at one hour before applying the graft, (2) at three months exactly post-operatively.)
- Shrinkage index at six months(Measurements will be done at two time points to calculate the amount of shrinkage :(1) at one hour before applying the graft, (2) at six months exactly post-operatively.)