NCT01771302已完成不适用
Randomized Clinical Trial on the Efficiency of PRGF-Endoret in Combination With a Bone Graft in Lateral Sinus Floor Elevation
Fundación Eduardo Anitua1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2013年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Percentage of newly-formed bone
研究概览
简要总结
This randomized clinical study investigates the efficiency of plasma rich in growth factors (PRGF-Endoret) in combination with bone grafts in the healing of bone and soft tissues after the performance of lateral sinus floor elevation.
The hypothesis of this study is that the use of PRGF-Endoret will produce similar bone formation regardless the type of bone graft.
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
- •Patients over 18 years
- •Patients requiring implant prostheses oral rehabilitation.
- •Patients with insufficient residual height in posterior maxilla requiring a sinus lift procedure to insert the implants
排除标准
- •Not having complete the informed consent form.
- •Sinusitis.
- •Alcoholism.
- •Suffering severe haematological disorder or disease.
- •Be undergoing or having received radiotherapy, chemotherapy or immunosuppressive therapy, corticosteroids and / or anticoagulants, 30 days prior to the study inclusion.
- •In usual treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or other anti-inflammatory drugs.
- •Background of chronic hepatitis or liver cirrhosis.
- •Diabetes mellitus with poor metabolic control (glycosylated hemoglobin above 9%)
- •Patients undergoing dialysis.
- •Presence of malignant tumors, hemangiomas or angiomas in the extraction area.
- •History of ischemic heart disease in the last year.
- •Pregnancy or intention to become pregnant during the study follow-up period.
- •Metabolic bone disease
- •Patients taking bisphosphonates drugs both orally and intravenously.
- •In general, any inability to participate in the study
结局指标
主要结局
Percentage of newly-formed bone
时间窗: 6 months after surgical intervention
The histomorphometrical analysis of the biopsies taken after 6 months of surgical intervention (time for dental implants insertion) will be performed to calculate the primary outcome
次要结局
- Pain index(7 days, 15 days, 1 month, 2 months, 6 months and 12 months after surgical intervention)
- Bone density(at baseline and after 6 months of intervention)
- Insertion torque(6 months after surgical intervention)
- Percentage of residual graft(6 months after surgical intervention)
- Infection(7 days, 15 days, 1 month, 2 months, 6 months and 12 months after surgical intervention)
- Healing index(7 days, 15 days and 1 month after surgical intervention)
研究者
研究点 (1)
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