The Effect of Advanced Platelet Rich Fibrin in Alveolar Defect After Removal of Bilateral Mandibular Third Molar
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Clinical Attachment Loss (CAL) (also called Periodontal Attachment Loss)
研究概览
简要总结
To evaluate the healing effect of advanced platelet-rich fibrin (blood clot charged with growth factors) taken from the patient own blood on the extraction site.
详细描述
This is a randomized double-blind clinical study. A preoperative and radiographic evaluation will be done in order to select the patients.
Inclusion criteria are healthy patients above 18 years old with vertical or mesioangular bilateral impacted mandibular third molars. Exclusion criteria are missing second molars or indicated for extraction (un-restorable and remaining roots), patients under immunosuppressant and patients with acute infection. Those who fail to attend for follow-up appointments will be excluded.
The probing depth (PD) and clinical attachment level (CAL) distal to the second molar will be measured before each procedure. All patients will undergo bilateral removal of 3rd molar in a single appointment. Envelope flap with distal extension and a full-thickness mucoperiosteal flap will be utilized and the teeth will be removed with elevators. Bone removal will be utilized if needed.
Following the extraction, venous blood will be withdrawn to fill 2 tubes of 10mL each (sterile vacuum plain tube for A-PRF™ +). The blood tubes will be spun in the centrifugation machine for 13 minutes at 1300 rpm then it is pressed in PRF Box to form PRF clots which will be placed in one the extraction socket while the other socket will not receive a PRF (control).Randomization will be done using a coin toss.
Both extraction cavities will be closed using 3-4 interrupted sutures using 3.0 chromic gut sutures.
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
- Quadruple (Participant, Care Provider, 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
- •Healthy patients above 18 years old with mirror image vertical or mesioangular bilateral impacted mandibular third molars
排除标准
- •Missing second molars or indicated for extraction (un-restorable and remaining roots).
- •Patients under immunosuppressant and patients with acute infection.
- •Patients who fail to attend for follow-up appointments.
研究组 & 干预措施
A-PRF group
Socket site that will receive A-PRF clot
干预措施: autologous blood clot made from the patient own clot without any additive (Other)
control
socket site that will not receive any intervention
结局指标
主要结局
Clinical Attachment Loss (CAL) (also called Periodontal Attachment Loss)
时间窗: At baseline and at follow-up 4 weeks and 12 weeks after extraction
Periodontal healing is evaluated based on changes in clinical attachment loss (mm)
次要结局
- Pain reported by the patient according to the visual analogue scale (VAS)(7 days after the extraction)
研究者
talal zahid
Assistant professor
King Abdulaziz University