Prospective Evaluation of Anorganic Bovine Bone Mineral Versus Calcium Phosphosilicate Alloplastic Bone Putty in Direct Sinus Augmentation: a Spilt-mouth Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Percentage of new bone growth in the maxillary sinus
研究概览
简要总结
The purpose of this split-mouth clinical study is to evaluate the clinical, radiographic and histological outcomes of lateral window sinus augmentation with a bovine xenograft or a CPS putty bone substitute in posterior maxillary sites and the survival of implants placed in these sites following healing.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with non-contributory medical history that will present for bilateral sinus lift surgery prior to implant placement
排除标准
- •Patients that will not agree to participate in this study or sign the consent form
- •More than 8mm of residual bone height at the implant site
- •Subjects smoking more than 10 cigarettes per day
- •History of acute sinus infection
- •History of prior maxillary sinus surgery (Caldwell-Luc, direct or indirect sinus lift, etc)
- •Medications that affect bone healing (chronic steroid regimen, oral or IV bisphosphonates, etc.)
- •Patients allergic to bovine derivatives
- •Patients who are a carrier of transmissible disease(s) that may unnecessarily expose laboratory personnel to risks
- •Females during pregnancy or lactation or females that plan to become pregnant in the following year (pregnancy test prior to enrollment)
研究组 & 干预措施
Anorganic bovine bone mineral in direct sinus augmentation
Anorganic bovine bone mineral
干预措施: Anorganic bovine bone mineral in direct sinus augmentation (Procedure)
Alloplastic bone putty in direct sinus augmentation
Alloplastic bone putty
干预措施: Calcium phosphosilicate alloplastic bone putty in direct sinus augmentation (Procedure)
结局指标
主要结局
Percentage of new bone growth in the maxillary sinus
时间窗: 7 months(plus minus 1 month)
Difference between the percentage of new bone growth between the two groups as determined by histomorphometric analysis of bone cores retrieved during implant placement surgery.
次要结局
- Gain in vertical bone height(6 months (plus or minus 1month))
- Primary implant stability(7 months (plus or minus 1 month))
- Radiographic bone density(6 months (plus or minus 1 month))
- Marginal bone level maintenance(12 months(plus or minus 1 month))