The Use of Bio-Oss Collagen for Sinus Augmentation Using the Transcrestal Approach.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Vertical bone height. (mm)Changes in augmented bone after transcrestal approach sinus augmentation.
研究概览
简要总结
To assess vertical bone height gain with Geistlich Bio-Oss Collagen used in conjunction with simultaneous implant installation in transcrestal approach sinus augmentation.
详细描述
One of the most common situations in the posterior maxilla is reduced alveolar bone height as a result of tooth extraction and the following bone remodeling process, and maxillary sinus pneumatization. Lack of alveolar bone volume may compromise dental implant installation. Maxillary sinus augmentation is considered a very predictable solution for implant installation in limited amount of bone in the posterior maxilla. In general, there are two main maxillary sinus augmentation methods: the lateral approach and the transcrestal. In both methods, the idea is to expend the alveolar ridge in vertical direction on the expense of the maxillary sinus. Sinus augmentation using the transcrestal approach is a well known procedure which is being use for over 40 years. As time goes by, implant dentistry is evolving and improving, there is a constant progress in this field including new bone substitutes materials.
Geistlich Bio-Oss® Collagen - can improve the results obtained by sinus augmentation using the transcrestal approach, by better ease of use for the operator which makes it easier for the operator and the patient.
Study hypothesis: The vertical bone height gained by using Geistlich Bio-Oss Collagen in transcrestal approach sinus augmentation will be comparable to using Bio-Oss Collagen, with greater operator satisfaction and less intra-operative complications.
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)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients above the age of
- •Patients with edentulous ridge maximal height of 8mm≥ beneath the maxillary sinus.
- •Patients with edentulous ridge minimal height of 3mm≤ beneath the maxillary sinus.
- •Patients who need single implant placement at the posterior maxilla.
- •Signed, well filled and dated informed consent form.
排除标准
- •Inability to complete or understand the informed consent process.
- •Pregnant women.
- •Lactating women.
- •Patients who use medications that affect bone metabolism such as IV bisphosphonates.
- •Heavy smokers.
- •Patients with chronic/acute sinus infections
结局指标
主要结局
Vertical bone height. (mm)Changes in augmented bone after transcrestal approach sinus augmentation.
时间窗: Pre op; immediately post-op, at 6 months and 3 years from second stage surgery.
Measuring the changes in augmented bone volume after transcrestal approach sinus augmentation.
次要结局
- Procedure time measurement. (min)(The procedure time measurement will start after flaps are elevated at pilot drilling (2.4mm diameter). and it will be stopped when the implant was inserted and insertion torque was assessed.)
- Patients and operator satisfaction. (1-10 ruler scale)(At the suture removal visit - 14 days after procedure.)
- Complications(During the procedure, During the follow up - 14 days, 6 months after intervention.)
- Procedure time measurement. (min)(The procedure time measurement will start after flaps are elevated at pilot drilling (2.4mm diameter). and it will be stopped when the implant was inserted and insertion torque was assessed.)
- Patients and operator satisfaction. (1-10 ruler scale)(At the suture removal visit - 14 days after procedure.)
- Complications(During the procedure, During the follow up - 14 days, 6 months after intervention.)
- The success rate of osseointegrated implants. (%)(At 6 months and 3.5 years after intervention.)
研究者
Hadar Zigdon MD
Rambam Health Care Campus
Rambam Health Care Campus