Assessment of Three-Dimensional Bone Augmentation of Severely Atrophied Posterior Mandibular Alveolar Ridges Using Customized-3D Zirconia Barriers Versus Pre-bent Titanium Mesh: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- change in vertical height of ridge
研究概览
简要总结
Zirconia can be considered as an alternative and innovative material suitable for GBR because it has high biocompatibility, together with a scarce tissue integration. Zirconia barriers could be a predictable and alternative barrier material for GBR in terms of (i) biocompatibility, (ii) ease of use and removal, (iii) exposure management, (iv) bone regeneration outcomes.
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
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are systemically medically free according to the American Society of Anesthesiologists (ASA) considered as ASA I.
- •Ability to maintain good oral hygiene as evidenced in recall visits.
- •patients who had a partial or completely edentulous alveolar ridge with apparent 3D defect following teeth loss.
- •All patients were free from any local or general disease that may interfere with bone healing and had no history of previous grafting procedure at the designated edentulous ridge.
- •The ridge had to exhibit severe vertical and horizontal (3D) alveolar ridge deficiency with alveolar ridge height less than 7 mm from the alveolar crest to the inferior alveolar canal and width less than 5 mm which was firstly measured by CBCT, or a clinically apparent increase in inter-arch space relative to the adjacent natural teeth.
- •Pre-operative clinical assessment of soft tissue coverage was done to cover the graft and its membrane, in addition to assessment of occlusion and inter-arch distance should allow for the graft, membrane, implan and the future prosthesis.
排除标准
- •Smoker (> 25 cigarettes/ day).
- •Patients undergoing radiotherapy or chemotherapy
- •Patients having infection or local lesions in the area of surgery.
- •Patients with diabetes mellitus or bone diseases which may compromise the results.
- •Patient with poor oral hygiene or active periodontal disease.
- •Patient with limited mouth opening.
- •Participation in other clinical trials
研究组 & 干预措施
Zirconia
干预措施: customized Zirconia barrier (Other)
Titanium
干预措施: prebent titanium mesh (Other)
结局指标
主要结局
change in vertical height of ridge
时间窗: up to 6 months
Cone Beam Computed Tomography (CBCT) was done immediately (1 week) and after six months to evaluate the changes in vertical, horizontal and volumetric measurements of the ridge. OnDemand3D™ software was used to evaluate vertical and horizontal height. Measurements were taken as follows: From the toolbar, the ruler was selected from the measurement section.
change in horizontal width of ridge
时间窗: up to 6 months
Cone Beam Computed Tomography (CBCT) will be done immediately (1 week) and after six months OnDemand3D™ software will be used. Measurements were taken as follows: From the toolbar, the ruler was selected from the measurement section.
change in volume of ridge
时间窗: up to 6 months
Cone Beam Computed Tomography (CBCT) will be done immediately (1 week) and after six months OnDemand3D™ software will be used. Measurements were taken as follows: From the toolbar, the ruler was selected from the measurement section.
次要结局
- symptoms of infection(up to one month)
- manifestations of wound healing disturbance(up to one month)
研究者
Hams Hamed Abdelrahman
Lecturer of Dental Public Health and biostatistical consultanat
Alexandria University