Adjunctive Benefit of Xenograft Plus a Membrane During Sinus Crestal Approach
试验速览
- 阶段
- 不适用
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Complications rate
研究概览
简要总结
Patients in need for implant-supported restoration in maxillary posterior sites with insufficient residual bone height will be randomly allocated to two different arms. Crestal sinus lift with simultaneous implant placement will be performed in both groups.
Control group: crestal sinus lift with no adjunctive biomaterial; Test group: crestal sinus lift associated with xenogenic bone graft and collagen membrane; Six months after implant placement, implants will be loaded with definitive screw-retained prostheses.
Six months later, patients will be recalled for clinical and radiographic assessment.
详细描述
Patients in need for implant-supported restoration in maxillary posterior sites with bone deficiencies will be randomly allocated to two different arms.
Full-mouth periodontal chart and standardized radiographs will be evaluated at the time of inclusion.
Crestal sinus lift with simultaneous implant placement will be performed in both groups.
Control group: crestal sinus lift with no adjunctive biomaterial; the healing abutment in this group is made up of PEEK (poly-ether-ether-ketone).
Test group: crestal sinus lift associated with xenogenic bone graft and collagen membrane; the healing abutment in this group is made up of titanium;
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
- Triple (Participant, Investigator, 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
- •more than 18 years old
- •edentulous in posterior maxilla
- •patient in need of sinus augmentation procedure
- •residual bone height greater than 3mm
排除标准
- •systemic chronic diseases affecting osseointegration
- •contraindication for implant therapy
- •less than 18 years
- •uncontrolled periodontitis
- •smoker (more than 10 cig/day)
结局指标
主要结局
Complications rate
时间窗: 12 months
amount of complications assessed at patient level
次要结局
- Soft tissue inflammation(6 months)
- Implant stability quotient(baseline, 1 month, 3 months, 6 months)
- Peri-implant bone stability(12 months)
研究者
Nicola Discepoli
Professor
University of Siena