Minimal Invasive Crestal Sinus Technique Using Autologous Fibrin Glue Versus Sticky Bone With Simultaneous Implant Insertion. A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Bleeding
研究概览
简要总结
prospective comparison of minimal Invasive Crestal Sinus Technique Using Autologous Fibrin Glue Vs Sticky Bone with simultaneous implant insertion.
详细描述
The aim of this study is to evaluate the clinical and radiographic outcomes of applying fibrin glue versus sticky bone in conjunction with crestal sinus lift technique associated with simultaneous implant insertion.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a) Patients should be willing to be present for regular timely follow up. b) Residual bone height range from 5 to 9mm c) Patent ostium of maxillary sinus. d) Patients having missing maxillary posterior teeth. e) Patient cooperation and compliance are indispensible for a predictable clinical outcome.
- •f) Patients free from any systemic disease
排除标准
- •Patients with systemic disease that prevent surgical intervention or bone healing.
- •Patients with acute or chronic maxillary sinusitis. 3) Patients with cyst, tumor or root tips at the planned surgical site. 4) Heavy smoker patients. 5) Elderly patients (over 60 years). 6) Patients with Poor oral hygiene or aggressive periodontal diseases. 7) Lack of motivation or inability to maintain oral hygiene.
结局指标
主要结局
Bleeding
时间窗: 3 months
Peri-implant mucosal bleeding will be graded using criteria of modified sulcus bleeding index (mBI). * Score 0; no bleeding when a periodontal probe was passed along the gingival margin adjacent to the implant. * Score 1; isolated bleeding visible spot. * Score 2; a confluent red line on the gingival margin was formed by blood. * Score 3; heavy or profuse bleeding is present.
Implant stability
时间窗: 3 months
implant stability using The Ostell ISQ scale: The ISQ scale ranges from 0 to 100 that measures implant stability. The values less than 60 indicate low implant stability; values from 60 to 69 indicate medium stability where values between 70 and 79 indicate high stability. 6 implants from each group will be assessed regarding implant stability at 3 months post-operative using this ISQ scale to determine implant stability and data will be analyzed statistically for significance.
Radiographic evaluation
时间窗: immediate postoperative
Cone beam computed tomography scan will be taken at preoperative visit to assess:Residual bone height (RBH) which is the distance from the alveolar crest to the floor of the maxillary sinus at the intended implant placement site. * Implant protrusion (IP):measured as the distance from the sinus floor to implant apex. * Graft height apically (GHa):the distance fom implant apex to the highest level of the grafting material (the new sinus floor). * Grafted sinus height (GSH):the distance from the original sinus floor to the new sinus floor which is the implant protrusion plus the graft height beyond the implant apex (IP +GHa).
次要结局
- Radiographic evaluation(6 months)
- implant stability(6 months)
- Bleeding(6 months)