One-stage Maxillary Sinus Elevation Using a Bone Core Containing an Implant From the Mandibular Symphysis: (A Randomized Controlled Trial)
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Survival rate of implant
研究概览
简要总结
Two groups of patients with atrophy in posterior maxilla indicated for sinus lift.
First group will be subjected to open sinus lift with chin bone graft. Second group will be subjected to sinus floor elevation using a bone ring.
详细描述
Two groups of patients with atrophy in posterior maxilla indicated for sinus lift.
(A) First group will be subjected to open sinus lift with chin bone graft.
- All cases will undergo surgery under general anesthesia for sinus lift and other surgery under local anesthesia for implant placement .
- Exposure of the anterior wall of maxilla according to standardized surgical approach.
- Open sinus lift and bone graft.
- After 6 months, implant will be drilled and inserted in the recipient site according to standard protocol.
- Loading on implant after 5-6 months.
(B)Second group will be subjected to sinus floor elevation using a bone ring.
- All cases will undergo surgery under local anesthesia for implant placement in the mandibular chin and other surgery under general anesthesia for sinus lift using bone ring with the implant.
- Exposure of the mandibular chin will be done under local anesthesia using a standardized surgical approach.
- Implant will be drilled and inserted in the chin according to standard protocol.
- After 3 months, second surgery under general anesthesia to place the implant and surrounding ring in the atrophied posterior maxilla.
- The bone ring containing the implant allowed to heal for 5-6 months.
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
盲法说明
Because the two interventions used in this trial are clearly different and easily recognized by the participants and investigators, neither the investigators nor participants can be blinded.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with at least a unilateral atrophied posterior maxilla indicated for open sinus lift and graft.
- •All ages and both sexes were included in this study.
- •Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
- •Patients with good general condition allowing surgical procedure under general anesthesia.
- •Patients with physical and psychological tolerance.
排除标准
- •Patients with high risk systemic diseases like uncontrolled diabetes. As uncontrolled diabetes has a negative impact on normal bone healing.
- •Patients with chronic sinusitis, maxillary sinus tumor or cyst. As they will affect accuracy of the procedure.
- •Patients with physical and psychological intolerance. As psychological stress will affect the immune system and patient's fitness including healing capacity. ]
研究组 & 干预措施
Open sinus lift using chin bone graft
Patients with atrophied posterior maxilla will undergo open sinus lift with chin bone graft according to standardized surgical approach.
干预措施: Open sinus lift using chin bone graft (Procedure)
Sinus lift using bone ring containing the implant
Patients with atrophied posterior maxilla will undergo sinus lift using bone ring containing the implant.
干预措施: Sinus lift using bone ring containing the implant. (Procedure)
结局指标
主要结局
Survival rate of implant
时间窗: One year post-operative.
The estimated annual failure rate will be assessed via clinical assessment, measuring unit (Binary yes\\ no)
次要结局
- Pain intensity(One month post-operative.)
- Established bone integration(Six months post operative.)
- Marginal bone loss around implant(one year post operative)
- Sinus membrane perforation(During operation)
研究者
Mohamed kamel hassan
Assistant lecturer
Cairo University