Marginal Bone Loss, Prosthetic and Mucosal Complications of Stress-free Implant Bars and Milled Bars Supporting Mandibular Overdentures. Three-years Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- marginal bone loss
研究概览
简要总结
The aim of this study will be to evaluate the marginal bone loss and prosthetic complications of stress-free implant (SFI) and milled bars used to assist mandibular 4-implant overdentures after 3 years
详细描述
Eight edentulous participants with insufficient stability of mandibular dentures will receive 4 implants in the mandibular ridge (2 implants in the canine areas and 2 implants in the first molar areas), and then after 3 months, patients will be randomly assigned into 2 groups; 1) group 1: will include 4 participants who will receive milled bar overdentures, and 2) group 2: will include 4 participants who will receive SFI bar overdentures. For both groups, marginal bone loss will be evaluated using the standardized digital periapical films at the time of insertion, 6 months, 1 year, and 3 years after insertion. Prosthetic and mucosal complications will be evaluated after 3 years.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mandibular edentulous ridge
排除标准
- •severe atrophy in mandibular ridge
研究组 & 干预措施
SFI group
干预措施: stress free implant bar (Procedure)
milled bar group
干预措施: milled bar (Procedure)
结局指标
主要结局
marginal bone loss
时间窗: time of insertion, 6 months, 1 year and 3 years
次要结局
- prosthetic complications as denture fracture, adjustment of denture margins, acrylic teeth wear/fracture, abutment fracture, abutment screw loosening/fracture, prosthetic screw loosening/fracture, metal housing loosening/wear, clip wear/replacement(3 years)
- mucosal complications include; mucositis/soreness of mandibular mucosa, ulcer of mandibular mucosa, hyperplasia under the bar(3 years)
研究者
Salsabeel A Afifi, PhD
lecturer of oral medicine and periodontology
Fayoum University
