Reconstruction of Horizontally Deficient Atrophic Maxillary Ridges Using Retromolar Blocks With and Without Coverage Using Collagen Membrane (Randomized Clinical Trials)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Quantity of bone gain.
研究概览
简要总结
Is the use of collagen membrane on top of particulate bone mixture covered by onlay bone block in Maxilla better than the use of mixture of particulate bone covered by onlay bone block without the use of collagen membrane, in terms of bone quantity?
详细描述
Soft tissue dehiscence could result due to flap irritation as a result of, closure under tension, intraoperative or postoperative recipient site infection, postoperative edema, which in turns compromises stability of onlay bone blocks thus osseintegration of bone block. Any attempt of bone recontouring and resuturing fails since there is no vascular bed. Ideal requirements of barrier membranes are, they should be biological compatible, they must act as a barrier membrane, unwanted fibroblasts should be hindered from entrance while allowing diffusion of nutrients, tissue integration (biological adhesion), tissues should be able to grow into the membrane but not through it. Space maintainer, it should be sufficiently stiff, so as not to collapse into the underlying particulate bone under the pressure of soft tissue and it should be ease in its manipulation, adaptation and handling, as for example, collagen membrane. Some types of collagen membrane, contain some degrees of stretchability example Geistlich Bio-Gide or Jason Membrane Botiss.
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
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with maxillary residual alveolar bone height not less than 8 mm.
- •Alveolar bone width from less than or equal 5 mm.
- •Both genders.
- •At least missing single tooth.
- •Previous Failed Implants.
- •Previous Failed Grafting.
排除标准
- •• Heavy smokers more than 20 cigarettes per day.
- •Patients with alcohol abuse
- •Patients with narcotic abuse.
- •Patients with bone disease that may affect normal healing, example; hyperparathyroidism.
- •Patients had radiotherapy and chemotherapy in head and neck.
- •Patients had neoplasms in sites to be grafted.
- •Patients with Metabolic diseases uncontrolled diabetic patients, Glycated hemoglobin (Hb A1c) more than 7 mg\dl.
- •Pregnant females.
- •Patients with Para functional habits, apprehensive and non-cooperative.
- •Bone pathology related to the site to be grafted.
- •Psychological problems, stress situation (socially or professionally), emotional instability, and unrealistic patients' expectations.
- •Intraoral soft and hard tissue pathology.
- •Systemic condition that contraindicate implant placement.
- •Under the age of 18 years.
研究组 & 干预措施
Study Group A: Retromolar bone block covered with collagen membrane.
The onlay bone block harvested from retromolar region and fixed with micro screws, a mixture of autogenous and xenogenic particulate bone graft is going to be packed in between the bone block and recipient site. The assembly is going to be covered with native collagen membrane and fixed with titanium bone tacks.
干预措施: Onlay bone block covered with collagen membrane (Procedure)
Control Group B: Retromolar bone block without collagen membrane.
The onlay bone block harvested from retromolar region and fixed with micro screws, a mixture of autogenous and xenogenic particulate bone graft is going to be packed in between the bone block and recipient site.
干预措施: Onlay bone block without collagen membrane (Procedure)
结局指标
主要结局
Quantity of bone gain.
时间窗: At 5 months from ridge augmentation.
Measured using linear measurements from Cone Beam Computed Tomography in millimeters.
次要结局
- Soft Tissue Dehiscence(Baseline 1st Week. Written Binary Numerical Yes or No.)
研究者
Mohannad Ahmed Ismail
Principle Investigator
Cairo University