Comparative Clinical and Histological Investigation of Graft Integration Following Piezosurgically Retrieved Lateral Bony Wall Repositioning in Maxillary Sinus Floor Augmentation - Prospective Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Duration of surgery
研究概览
简要总结
The aim of the present prospective randomized controlled study is to clinically and histologically investigate the safety and efficacy of bony wall repositioning compared to rotary window preparation with membrane coverage in maxillary sinus floor augmentation.
详细描述
40 patients were randomly divided in two study groups after radiological and clinical evaluation. Both groups received bone grafting by a xenogeneic bone substitute (BSM, cerabone, botiss biomaterials GmbH, Zossen, Germany) using the lateral approach. In the bony wall group (BW), following piezosurgery the retrieved bony wall was repositioned. In the collagen membrane group (CM), the lateral window was created by rotary instruments, covered via a native collagen membrane (collprotect, botiss biomaterials GmbH, Zossen, Germany). After 6 months, biopsies were taken to analyze both approaches in terms of new bone formation. Duration of treatment, the number of perforations, postoperative patient discomfort were registered. Established histopathological analysis and histomorphometrical measurements to analyze the tissue reactions and the tissue distribution, i.e., the fractions of newly formed bone tissue (NB), of remaining bone substitute material (BSM) and connective tissue (CT), were conducted.
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 (Outcomes Assessor)
盲法说明
Histology analysis was performed blinded, randomization sequence was revealed after histomorphometry
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •at least one missing maxillary premolar or molar
- •at least 7 mm crestal bone width confirmed by preoperative ConeBeam Tomography (CBCT)
- •maximally 5 mm residual bone height at the sinus floor confirmed by preoperative ConeBeam Tomography (CBCT)
- •full mouth plaque and bleeding scores (FMPS and FMBS) <20%
- •satisfactory patient compliance (e.g. to participate in follow-up procedures)
- •signed informed consent.
排除标准
- •clinically relevant diseases (e.g.: diabetes, rheumatism cancer)
- •untreated periodontitis
- •systemic steroid use
- •bisphosphonate use
- •acute or chronic inflammatory processes
- •previous endoscopic sinus surgery
- •previous sinus floor elevation
- •GBR-treatment at the study site
- •GTR-treatment at the study site
- •tooth removal within 6 weeks prior to surgery
结局指标
主要结局
Duration of surgery
时间窗: During smaxillary sinus augmentation
Recorded in minutes
次要结局
- Duration of lateral window preparation(During maxillary sinus augmentation)
- Duration of mucosa preparation(During maxillary sinus augmentation)
- Visual Analog Scale (Minimum value 0, Maximum value 100, the higher the worse)(1 day postoperatively)
- Postoperative Edema Score(3 days postoperatively)
- Histomorphometrical analysis(Following reentry 6 months after maxillary sinus augmentation)
研究者
Balint Molnar
Dr. Balint Molnar DMD, PhD, associate professor
Semmelweis University