Influence of Human Platelet Derivatives on Dental Implant Osseointegration
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Osseointegration
研究概览
简要总结
The goal of this randomized controlled trial is to evaluate the benefit of PRF membrane on bone around dental implant in patients who need treatment with dental implant.
Aims of the study:
- To study the effect of PRF membrane (with or without bone substitute on increasing bone dimension around dental implant.
- To investigate the effects of compositions of PRF (platelets count, WBC count) on bone healing.
详细描述
Materials and methods
PRF will be obtained from a blood sample that is taken from the patient at the time of surgery in 10-mL tubes, the blood-containing tube is placed in a centrifuge at specially controlled rotations, temperature and time. The result is the separation of blood, basically from two by-products, including PRF. The PRF clot will be placed in specific box ( P.R.F -System; Surgident, CE ) to create a PRF membrane with specific thickness that will be placed on the bone around dental implant.
Evaluation of the results
- Alveolar bone width around dental implant will be measured.
- Histological examination of the tissue that excised during dental implant uncover surgery.
- Evaluate pain by visual analogue score (VAS).
- Estimate the count of WBC and platelets in whole blood will be obtained from a laboratory results.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •IInclusion criteria
- •Non- smoker.
- •No medical history of any systemic diseases that affect the bone metabolism.
- •Did not receive any systemic drugs.
- •Has edentulous area that needs dental implant.
排除标准
- •were as follows:
- •Systemic disease or medication compromising bone and soft tissue healing.
- •Pathology in the edentulous region.
- •Disease of the oral mucosa.
研究组 & 干预措施
experimental group
Placing dental implant with PRF membrane treatment alone or combined with bone substitute.
干预措施: PRF membrane (Biological)
control group
Placing dental implant
结局指标
主要结局
Osseointegration
时间窗: Immediately after surgery, after 12 weeks (during uncover implant surgery)
Evaluation of the changes in the degree of osseointegration will be performed using Osstell devise. \[Osstell ISQ device. (Stampgatan, Gteborg, Sweden)\] The Unit of measurement: ISQ (Implant Stability Quotient), which is a scale from 1 to 100.
Bone width
时间窗: Baseline (pre-surgery), immediately after the surgery, after 4 weeks, 6 weeks, 8weeks, 10 weeks, and 12 weeks.
Measure the dimensional changes using special caliper (vernier) measurement tool, to evaluate the changes of bone width around dental implant. the Unit of measurement: millimeter (mm) (Bone and mucosa)
次要结局
未报告次要终点
研究者
Afya Sahib Diab Al-radha
Assistant Professor
Al-Mustansiriyah University