Application of Platelet-Rich Fibrin Consolidated Bone Substitutes in Alveolar Ridge Preservation: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 14
研究概览
简要总结
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of age between 18-
- •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.
排除标准
- •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