Prosthesis and Implant Survival in Immediately Loaded Full Arch Restorations Using Fiber Reinforced Versus Non-reinforced Temporary Frameworks: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 114
- 主要终点
- Prosthesis survival
研究概览
简要总结
In immediate loading of implants of completely edentulous patients, the most common post-surgical complication following the surgery noted in the dental literature is fracture of the provisional restoration with rates ranging from 4.17% to 41%. Most of these fractures occur because polymethyl methacrylate (PMMA) materials are inadequate and have low rigidity to withstand extended periods of heavy occlusal use.
Fractures of full arch provisional restorations during healing are concerning, because they eliminate cross-arch stabilization and disrupt stress distribution patterns which might jeopardize implant osseointegration affecting the survival rates for implants. Therefore, it is important to look for another material that has higher rigidity than PMMA and can withstand masticatory forces for extended periods without fractures or load concentration on the implants during the osseointegration period.
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 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Completely edentulous patients.
- •Patients with proper amount of attached gingiva (≥2 mm)
排除标准
- •Patients having a medical condition that absolutely contraindicates implant placement.
- •Patients with uncontrolled diabetes, assessed by measuring glycosylated hemoglobin (HbA1c). (greater than 6.4 percent)
- •Potentially uncooperative patients who are not willing to go through the proposed interventions.
- •Moderate-to-heavy daily smokers* (who report consuming at least 11 cigarettes/day).
- •Patients with history of bruxism
- •If insertion torque for the implants is less than 35 Ncm
研究组 & 干预措施
Non-reinforced full arch acrylic restorations
干预措施: No framework (Procedure)
full arch acrylic restorations with fiber-reinforced framework
干预措施: Fiber-reinforced framework (Procedure)
结局指标
主要结局
Prosthesis survival
时间窗: 4 months
Clinical evaluation of any fracture in the prosthesis
次要结局
- Peri-implant crestal bone loss during healing(4 months)
- Implant survival(4 months)
研究者
Nermeen Ahmed Hassan
PhD candidate
Cairo University
