Osseodensifiction Versus Piezoelectric Internal Sinus Elevation (PISE) Technique in Delayed Implant Placement (A Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Radiographic assessment of change in the vertical bone height (bone gain)
研究概览
简要总结
The present study is a parallel single-blinded randomized controlled clinical trial.
The study will be conducted after being reviewed and approved by the Faculty of Dentistry, AinShams University Research Ethics Committee (FDASU-REC).
The study population will be randomly allocated into two groups of the same size:
Group 1: Osseodensifiction sinus lift will be performed using sticky bone as a graft material.
Group 2: Piezoelectric Internal Sinus Elevation (PISE) will be performed using sticky bone as a graft material.
The aim of the present study is to evaluate the effectiveness and clinical results of osseodensification in comparison to Piezoelectric Internal Sinus Elevation (PISE) Technique in Delayed Implant Placement.
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 (Participant)
盲法说明
computer-generated randomization table
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient partially edentulous with maxillary posterior edentulous ridge after extraction of more than 4 months.
- •Both sexes will be selected males and females.
- •Adult patients aged between 18 and 40 years of age.
- •Good general health (American Society of Anesthesiology Physical Status Ⅰ-Ⅱ).
- •Initial residual alveolar ridge height ranging between 4 to 6 mm according to preoperative CBCT.
- •No previous surgery or radiation treatment on the maxillary sinus.
排除标准
- •Pregnant or lactating females.
- •Psychiatric disorders.
- •Uncontrolled systemic disease.
- •Hematologic diseases and coagulation disorders.
- •Chemotherapy or radiotherapy of the head and neck area, and immunocompromised status.
- •Medical conditions affecting bone metabolism and ongoing treatment with bisphosphonates drugs or systemic steroids.
- •Presence of acute or chronic sinus pathoses or sinus membrane perforation.
结局指标
主要结局
Radiographic assessment of change in the vertical bone height (bone gain)
时间窗: per-operative and immediately post-operative
Immediate postoperative CBCTs will be taken to all participants to assess bone gain .
Radiographic assessment of bone density
时间窗: per-operative and immediately post-operative
Immediate postoperative CBCTs will be taken to all participants to assess bone density.
次要结局
- patient post-operative pain assessment(1 week post-operative)
- operator's satisfaction assessment(1 year)
- implant primary stability (ISQ)(during procedure)
- implant primary stability (insertion torque )(during procedure)
- patient's satisfaction assessment(1 week post-operative)
研究者
Mohammed Samir
Resident ( Principal Investigator)
Ain Shams University