The Effectiveness of Hyaluronic Acid on Prefabricated CAD CAM Bone Blocks for Ridge Augmentation: A Split Mouth Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- measurement the width and the height of the alveolar ridge
研究概览
简要总结
Each patient will receive 2 prefabricated CAD-CAM allogeneic bone blocks sterilized with gamma rays with different rehydration methods.
Side I: prefabricated CAD-CAM allogeneic bone block sterilized with gamma rays hydrated using hyaluronic acid * Side II: prefabricated CAD-CAM allogeneic bone block sterilized with gamma rays hydrated using saline solution Both blocks are fixed with osteosynthesis screws, covered with non resorbable membranes** The membranes will be removed after 6 months, dental implants will be placed and core biopsy will be collected from the site of the implant placement for histologic evaluation
详细描述
10 patients will be included in this study with bilateral atrophic posterior mandible for split mouth research
. group I: prefabricated CAD-CAM allogeneic bone block sterilized with gamma rays hydrated using hyaluronic acid group II: prefabricated CAD-CAM allogeneic bone block sterilized with gamma rays hydrated using saline solution under LA mucoperiosteal flap will be elevated to expose the atrophic ridge then the prefabricated CAD-CAM allogenic block either mixed with hyaluronic acid (group I) or saline (group II) will be fixed in its position with titanium miniscrews , The block was coated with a nonporous d-PTFE membrane then closure of flap with nylon second stage: 6 months later exposure of alveolar ridge core biopsy was taken for histological study then insertion of titanium implants.
the aim of the study is to investigate the effect of hyaluronic acid on a prefabricated CAD- CAM bone blocks for ridge augmentation radiographically and histologically.
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
- Double (Participant, Outcomes Assessor)
盲法说明
using closed envelop for participants the data will be given to outcomes assessors without defining the intervention for each group
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Systemic diseases that affect host healing responses.
- •Heavy smoking.
- •Poor oral hygiene.
- •Traumatic occlusion, sever para-functional habits (ex. bruxism, clenching,)
结局指标
主要结局
measurement the width and the height of the alveolar ridge
时间窗: 6 months
using CBCT the width and the height will be measured with measuring tools in milimeter (mm)
the amount of new bone formation
时间窗: 6 months
core biopsy will be underwent histomorphometric analysis to determine the percentage of new bone formation (%)
次要结局
- the sucess of dental implants(12 months)
研究者
Mohamed Hamdy Helal
lecturer of oral medicine, periodontology, oral diagnosis and radiology department
Tanta University