Intraoperative and Postoperative Outcomes of Sinus Floor Elevation Using Lateral Window Technique Versus Hydrodynamic Transalveolar Approach: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- Sinus membrane perforation
研究概览
简要总结
Several approaches have been used in order to regenerate bone in the upper jaw in case of insufficient alveolar bone height for implant placement. However, new emerging techniques need to be assessed and compared to conventional methods in order to define their potential indications.
The purpose of the present randomized controlled clinical trial was to compare the clinical outcomes of two sinus floor elevation techniques: conventional lateral window technique versus a novel transalveolar approach using hydrodynamic ultrasonic device.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •edentulism in the posterior maxilla (unitary or plural)
- •need of a sinus floor augmentation procedure before implant placement
排除标准
- •any uncontrolled systemic disease
- •ongoing chemo- or radiotherapy
- •history of maxillary sinus diseases or acute sinus-related issues
结局指标
主要结局
Sinus membrane perforation
时间窗: During the surgery (from beginning to end)
Presence/absence of sinus membrane perforation during the surgery
Surgical procedure duration
时间窗: From beginning of surgery until the end of surgery
The time measurement started from the administration of local anesthesia and ended when the placement of final suture was completed. The time was measured using a stopwatch.
Edema
时间窗: From the end of surgery up to 1 week postoperatively
Presence/absence of edema postoperatively
Hematoma
时间窗: From the end of surgery up to 1 week postoperatively
Presence/absence of hematoma postoperatively
Postsurgical bleeding
时间窗: From the end of surgery up to 1 week postoperatively
Presence/absence of bleeding postoperatively
Nasal discharge
时间窗: From the end of surgery up to 1 week postoperatively
Presence/absence of nasal discharge postoperatively
NSAID consumption
时间窗: From the end of surgery up to 1 week postoperatively
Quantification of NSAID consumption per day up to 1 week postoperatively (tablets/per day)
Patient related outcome measures (PROMs)
时间窗: From right before the surgery up to 1 week postoperatively
PROMs were assessed with a questionnaire using a visual analogue scale (VAS), which was given to all participants in order to assess their perception before, during, and after the intervention. A graduated scale from 0 to 10 was used, with a lower score presenting a better outcome.
次要结局
- Radiographic outcomes(From the baseline (surgery procedure) up to 1 year post-surgery)
- Implant survival rates(From the baseline (surgery procedure) up to 1 year post-surgery)
研究者
Dr. France LAMBERT
Professor
University of Liege