Minimally Invasive Lateral Approach for Sinus Augmentation: a Split-mouth Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- height of augmented bone
研究概览
简要总结
It is assumed that the minimally invasive lateral approach and the traditional lateral sinus lift procedure will result in better outcomes in terms of height of augmented bone.
It is also assumed that the minimally invasive lateral approach will reduce surgical complications and patient's discomfort in comparison with a traditional lateral sinus lift procedure.
详细描述
16 patients edentulous in maxillary posterior area will be treated with a bilateral sinus lift procedure.
Once a patient will be enrolled in the study impressions will be taken. After the wax-up, a radiographic stent will be prepared. Special attention will be given to position radio-opaque references in the positions where the implants will be inserted according to a prosthodontic guided insertion. Pre-surgical CT scan will be executed after placing the stent in its proper position in patient's mouth. After that, if no surgical contra-indications will be detected at CT evaluation, patients will be enrolled for surgical interventions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- patient edentulous in the maxillary posterior area on both left and right side( not completely edentulous).
- •- residual bone height in the maxillary premolar and molar region less than 4mm.
排除标准
- •- history of systemic diseases that would contraindicate surgical treatment
结局指标
主要结局
height of augmented bone
时间窗: 6 months
次要结局
- post surgical patient's discomfort(2 weeks)
研究者
nicola baldini
oral surgeon
University of Firenze and Siena, Napoli, Italy