Sinus Floor Elevation Using Particulate and in Situ Hardening Biphasic Calcium Phosphate Bone Graft Substitutes: A Prospective Histological and Radiological Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Sinus floor height change
研究概览
简要总结
The study aims to investigate the radiological and histomorphometric results of the use of PLGA-coated biphasic calcium phosphate granules in sinus floor elevation, to analyze the underlying molecular processes by immunohistochemical staining, and to evaluate the handling of the biomaterial and the in situ hardening properties.
A randomized clinical study is designed to include patients in need of two-stage sinus floor elevation. Patients are assigned to receive either PLGA-coated biphasic calcium phosphate particles (group I) or the equivalent but non-coated particles (group II). CBCT scans are performed before and 6 months after the procedure to assess the bone height gain. At the time of implant placement, bone core biopsies are obtained at the site of implant placement. 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 or II in the upper jaw, from first premolar to second molar.
- •Less than 5 mm of residual crestal bone.
- •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
Non-coated HA/TCP particles
Biphasic hydroxyapatite and beta-tricalcium phosphate bone graft
干预措施: Non-coated HA/TCP particles (Device)
PLGA-coated HA/TCP particles
Biphasic hydroxyapatite and beta-tricalcium phosphate bone graft with PLGA coating
干预措施: PLGA-coated HA/TCP particles (Device)
结局指标
主要结局
Sinus floor height change
时间窗: 6 months
CBCT scans are performed before the sinus floor elevation and 6 months later before implant placement to measure vertical bone height 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