Innovative Approach in Guided Bone Regeneration Using Digitally Designed Surgical Guide
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- flap dehiscence
研究概览
简要总结
The goal of this clinical trial is to compare amount of bone resorption and flap dehiscence following guided bone regeneration with or without digitally designed surgical guide. The main questions it aims to answer are:
- Does it differ in amount of bone resorption between the conventional and digital guided bone regeneration?
- What is the difference between conventional and digital protocols regarding flap dehiscence following guided bone regeneration? Researchers will compare digital guided versus conventional technique to choose adequately which protocol to use.
Participants will:
- Receive guided bone regeneration around implant
- Visit the clinic after 2,7,14 days for detection any signs of flap dehiscence
- Bone gain and bone density will be assessed after 6 months
详细描述
Twenty sites with ridge defects will be recruited for this study. All investigations will be carried out in accordance with the 1975 Helsinki Declaration, as revised in 2013 for clinical approval. The purpose of the present study will be explained to the patients and informed consents will be obtained . Sites were randomly divided into 2 treatment groups .10 sites will be treated with bone graft (50%autogenous mixed with 50%xenograft) covered with bilayer collagen membrane without use of guide & 10 sites will receive the same treatment except it will be guided using digitally designed guide. Membranes in both groups will be stabilized by tacks. Following clinical parameters will be recorded: the wound opening of buccolingual distance between sutured flap margins with a UNC periodontal probe to the nearest millimeter at 2, 7 and 14 days, flap dehiscence. Also, bone gain and bone density will be assessed using cone beam computed tomography (CBCT) at baseline and 6 months post-surgery. The collected data was statistically analyzed at the different follow up periods.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •medium horizontal ridge defect according to clone classification
- •must have a general health showing no contraindications for surgery
- •must be at least 35 years old
- •patients also have adequate soft tissue thickness and width of keratinized gingiva
排除标准
- •no sign of uncontrolled systemic diseases
- •non smoker
- •not pregnant
- •sever ridge deficient
- •patients below 18 years old
结局指标
主要结局
flap dehiscence
时间窗: 14 days
the flap dehiscence will be assessed using a UNC periodontal probe through the the wound opening of buccolingual distance between sutured flap margins
次要结局
- bone gain(6 months)
- bone denisty(6 months)
研究者
Mona Al-Ahmady El-Meligy
lecturer of periodontology
Tanta University