NCT05031156Unknown不适用
Effect of Mandibular Immediately Loaded, Screw-retained Splinted and Non-splinted OT Bridge Implant Restoration on Bone Height Changes of Completely Edentulous Patients (A Randomized Clinical Trial)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 35
- 主要终点
- Marginal Bone loss
研究概览
简要总结
Evaluation of Bone level changes around dental implants in All on 4 cases with immediate loading using conversion denture and OT Bridge system either splinted or not
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any completely edentulous patient (mandible) with an old satisfactory denture requiring an implant-supported restoration.
- •Patients aged from 40 to 70, able to sign an informed consent will be considered eligible for this trial.
- •Implant sites must allow the placement of four implants.
- •Non- heavy Smokers will be included (smoking up to 10 cigarettes/day)
- •In case of post-extractive sites, they must have been healed for at least 3-month before being treated in the study.
- •Patients with no systemic condition that may interfere with implant placement (e.g., Immunosuppressed or immunocompromised patients, patients under treatment of intravenous amino-bisphosphonates)
排除标准
- •- Patients with poor oral hygiene and motivation.
- •Pregnancy or nursing.
- •Drug abusers.
- •Psychiatric problems or unrealistic expectations.
- •Patients with infection and or inflammation in the area intended for implant placement.
- •Patients participating in other studies, if the present protocol cannot be properly adhered to.
- •Patients with signs of hyperactive muscles.
研究组 & 干预措施
non-splinting of OT Bridge system
Active Comparator
Leaving the dental implants abutments solitary followed by denture pick up
干预措施: Splinting of OT Bridge system (Procedure)
splinting of OT Bridge
Experimental
Splinting of implants abutments using titanium wire then followed by denture pick up
干预措施: Splinting of OT Bridge system (Procedure)
结局指标
主要结局
Marginal Bone loss
时间窗: 3 monts
Measures the changes around the dental implants along the healing period using paralleling technique radiograph and DIGORA system
次要结局
- Early implant failure(3 months)
研究者
tasneem gamal youssef el mashad
Assistant lecturer of Prosthodontics
Cairo University
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