Algae-derived Hydroxyapatite Behaviour as Bone Biomaterial in Comparison to Anorganic Bovine Bone. A Randomised Split-mouth Human Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Sinus floor height change
研究概览
简要总结
The study aims to evaluate the clinical and radiological behavior, the histological and morphometrical components, the expression of proteins related to bone formation, and the analysis of markers of reparative mesenchymal stromal cells, after using a biphasic phicogenic biomaterial in comparison with anorganic bovine bone.
A randomized split-mouth clinical study is designed to include patients in need of two-stage bilateral maxillary sinus floor elevation. Patients are assigned to receive a mix of autogenous bone and a biphasic phycogenic biomaterial in one maxillary sinus and a mix of autogenous bone and xenograft bovine hydroxyapatite in the other maxillary sinus. Cone-beam computerized tomography (CBCT) scans are performed before sinus floor elevation and 6 months after the procedure to assess the bone gain. Bone core biopsies are obtained at the site of implant placement 6 months after the floor elevation. Histological sections are subjected to histomorphometric and immunohistochemical evaluation of differentiation markers.
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
- 否
入选标准
- •Partially edentulous patients.
- •Kennedy class I in the upper jaw.
- •Less than 5 mm of residual crestal bone to the maxillary sinus.
- •Need for the replacement of teeth with dental implants.
排除标准
- •Sinus pathology (sinusitis, mucocele, cysts).
- •Previous long-term (>3 months) use of drugs known to affect bone metabolism, such as bisphosphonates.
研究组 & 干预措施
Biphasic phycogenic biomaterial
Biphasic phycogenic biomaterial and Autogenous cortical bone
干预措施: Biphasic phycogenic biomaterial (Device)
Xenograft bovine hydroxyapatite
Xenograft bovine hydroxyapatite and Autogenous cortical bone
干预措施: Xenograft bovine hydroxyapatite (Device)
结局指标
主要结局
Sinus floor height change
时间窗: From surgery to 6 months
CBCT scans are performed before the sinus floor elevation and 6 months later before implant placement to calculate vertical bone height change from the crestal bone to the floor of the maxillary sinus
次要结局
- Area of new mineralized tissue(6 months)
- Area of non-mineralized tissue(6 months)
- Area of remaining graft particles(6 months)
研究者
Pablo Galindo-Moreno
Full Professor of Oral Surgery and Implant Dentistry
Universidad de Granada