Platelet-Rich Fibrin (PRF) vs Bone Graft With Membrane for Ridge Preservation After Tooth Extraction
Application of Platelet-Rich Fibrin Consolidated Bone Substitutes in Alveolar Ridge Preservation: A Randomized Controlled Study
This study uses a natural material called Platelet-Rich Fibrin (PRF) to help improve healing after tooth removal. PRF is made from your own blood. A small amount of blood is taken from your arm and spun in a machine to make a thick, sticky layer full of platelets. These platelets help your body heal. PRF acts like a "natural bandage" and may help your gums and bone heal faster. Because it comes from your own body, it is safe and lowers the chance of infection or problems.
The goal of this research is to see if adding PRF to a bone graft (used to fill the tooth socket after extraction) can help the area heal faster and grow more new bone.
If you join this study, it will last about 4 months. You will have two teeth removed, and each socket will get a different treatment:
- One socket (test side) will get PRF + bone graft (this combination is also called "sticky bone").
- The other socket (control side) will get a bone graft + a covering called a barrier membrane (made of collagen).
We will compare how well the two sides heal by looking at:
- How the gums close over the area
- How much pain you feel
- How much the bone changes
- How much new bone grows You will come to the clinic for about 9 visits in total. These visits are part of your regular treatment, along with a few extra steps for the study.
One possible risk is bruising or soreness from the blood draw. If we cannot collect enough blood (about 60-80 ml) because your veins are too small or hard to find, you will not continue in the study, and both sockets will be treated using the control method (bone graft + membrane).
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Siraj Zabadi, DDS
- 电话号码：614-206-0298
- 邮箱：Zabadi.1@osu.edu
研究联系人备份
- 姓名：Guo-Liang Cheng, DDS, MS
- 邮箱：cheng.712@osu.edu
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Patients of age between 18-80.
- Non-smokers or former smokers with at least a 5-year successful cessation history.
- Patients with normal systemic health (ASA-I) or well-controlled/stable systemic conditions (ASA-II), such as diabetes with HbA1c < 7.0%, no recent acute myocardial infarction and cerebrovascular accidents within 6 months, or any contraindication for periodontal or implant surgery.
- Patients treatment planned for extraction and ridge preservation for at least 2 non-adjacent single-rooted teeth.
Exclusion Criteria:
- Current smokers, smokers who have quit <5 years prior to study entry.
- Pregnant or lactating women
- Patients with substance or alcohol abuse
- Patients with a history of antiresorptive therapy, head and neck radiotherapy, and chemotherapy for malignant tumors
- Other systemic conditions or medications affecting wound healing.
- Poor plaque control with plaque score > 20%
- Active/untreated odontogenic and periodontal infections
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：PRF-solidified bone graft
Extraction socket is grafted with freeze-dried bone allograft (FDBA) mixed with autologous platelet-rich fibrin (PRF) to form a cohesive graft, without placement of a barrier membrane.
|
Autologous platelet concentrate prepared from the participant's blood and applied to the extraction socket, mixed with bone graft.
Human-derived bone graft material used to fill extraction sockets for ridge preservation
|
|
有源比较器：Bone Graft With Collagen Membrane
Extraction socket is grafted with freeze-dried bone allograft (FDBA) and covered with a resorbable collagen membrane for ridge preservation.
|
Human-derived bone graft material used to fill extraction sockets for ridge preservation
Resorbable membrane placed over the grafted socket to stabilize the graft and prevent soft tissue ingrowth.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in alveolar ridge dimensions
大体时间：4 months after ridge preservation (prior to implant placement)
|
Change in alveolar ridge width and height will be measured by superimposing baseline and 4-month follow-up cone-beam computed tomography (CBCT) images at standardized cross-sectional locations corresponding to the extraction sites.
|
4 months after ridge preservation (prior to implant placement)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Wound healing (re-epithelialization)
大体时间：1, 2, 3, and 4 weeks after ridge preservation
|
Soft tissue wound closure over extraction sites will be assessed using serial intraoral scans and analyzed to quantify changes in wound area over time.
|
1, 2, 3, and 4 weeks after ridge preservation
|
|
Percentage of new bone formation
大体时间：4 months after ridge preservation (at implant placement)
|
Bone core biopsies obtained at implant placement will be analyzed histologically to determine the percentage of newly formed bone within the grafted sites.
|
4 months after ridge preservation (at implant placement)
|
|
Crestal soft tissue thickness
大体时间：4 months after ridge preservation (at implant placement)
|
Soft tissue thickness at the alveolar crest will be measured clinically using a periodontal probe at the time of implant placement.
|
4 months after ridge preservation (at implant placement)
|
|
Postoperative pain score
大体时间：1, 2, 3, and 4 weeks after ridge preservation
|
Participant-reported pain will be assessed using a visual analog scale (VAS, 0-100), where higher scores indicate greater pain intensity.
|
1, 2, 3, and 4 weeks after ridge preservation
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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