Hydraulic Pressure Sinus Lift Versus Piezoelectric Lift Via Lateral Approach: A Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- radiographic appraisal of gain in alveolar bone height
研究概览
简要总结
the study aims to assess the effectiveness of hydraulic pressure sinus lift via lateral wall approach, versus piezoelectric surgery in patients with deficient posterior maxilla.
详细描述
This study involves a randomized clinical trial of 20 participants with less than 6 mm bone height in the posterior maxilla in need of Maxillary Sinus Floor Augmentation using the lateral window approach. Patients will be randomly assigned to two groups; the HPLT Group which include 10 patients who will undergo hydraulic pressure for osteotomy preparation for lateral sinus lifting technique, and the PSLT Group which include 10 patients managed using piezoelectric surgery. Clinical and radiographic assessment of bone augmentation, as well as intraoperative biological complications and postoperative complications were recorded.
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 (Investigator)
盲法说明
patients were allocated in a 1:1 ratio using an on-site computer software system with concealed allocation through sequentially numbered, opaque, sealed envelopes (SNOSE). This was a double-blind study, so neither the statistical analyst nor the patients were aware of the surgical procedure
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study included patient with deficient posterior maxilla with less than 6mm of bone height confirmed by a pre-operative tomographic scan. All healthy (ASA I, II) non- smoker patients were eligible for the study. The absence of uncontrolled diabetes, systemic illnesses, sinusitis, immune deficiency disorders, were also required for inclusion.
排除标准
- •Patients with sinus infection, neoplasm or a large cyst of the sinus, or those who previously underwent a Caldwell-Luc surgery for the same surgical site were excluded
研究组 & 干预措施
HPLT Group
patients with posterior deficient maxilla managed with osteotomy for lateral sinus floor augmentation using the Hydraulic Pressure Lifting Technique with A.I drill and hydraulic-powered Aqua-Lifter (OLA system) were assigned to HPLT Group
干预措施: Hydraulic Pressure Lifting Technique (Device)
PSLT Group
posterior deficient maxilla managed with osteotomy for lateral sinus floor augmentation using Piezo-Surgical Lifting Technique were assigned to PSLT Group
干预措施: Piezo-Surgical Lifting Technique (Device)
结局指标
主要结局
radiographic appraisal of gain in alveolar bone height
时间窗: 6 months
Postoperative radiographic appraisal was conducted by an immediate postoperative CBCT, followed by other one after 6 postoperative month's. Measurements of the bone height was conducted from the alveolar crest to the floor of the maxillary sinus on a cross-section view of the CBCT (Carestream Health, Rochester, NY). Radiographic assessment of the amount of bone height gain in 6 months period was performed by comparing the bone height measurements between the 6 postoperative months' CBCT with the preoperative scan.
次要结局
- incidence of membrane perforation(Until the end of the operation)