Evaluation of Stability and Crestal Bone Changes Around Implants Placed at Crestal Versus Subcrestal Level in Controlled Type Two Diabetic Patients (Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- change in Implant stability
研究概览
简要总结
The objective of this study is to assess clinically the peri implant tissues, the radiological marginal bone loss and the stability around implants placed at the crestal versus the subcrestal level in type 2 controlled diabetic patients using cone beam computed tomography
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 controlled diabetic patients
- •Patients with at least one missing tooth in lower jaw.
- •Patients with sufficient alveolar ridge height and width (no need for bone augmentation).
- •Patients with sufficient inter-occlusal distance that will allow future restoration.
- •Patients with healthy periodontium.
排除标准
- •Para functional habits.
- •Bad oral hygiene measured according to O'Leary plaque index.
- •Pregnant women.
- •Other local or systemic diseases that may compromise the surgical procedure, healing or osteointegration.
研究组 & 干预措施
Crestally positioned implants
干预措施: Implants placed at bone crest (Procedure)
Subcrestally positioned implants
干预措施: Implants placed 1mm Subcrestally (Procedure)
结局指标
主要结局
change in Implant stability
时间窗: at baseline and 3 months
Implant stability will be measured again by Osstell at 3 different directions (buccal, mesial and distal) at the time of implant loading (after 3 months from implant placement).
change in margianl bone level
时间窗: at baseline, 3rd and 6th months
CBCT will be done Marginal bone loss in all aspects (mesial, distal buccal and lingual) The difference in distance from bone crest to apical end of the implant will be assessed at each follow up period then the mean will be calculated for mesial and distal and also for buccal and lingual.
次要结局
未报告次要终点
研究者
Hams Hamed Abdelrahman
Assistant lecturer of DPH and Clinical statistician
Alexandria University