Comparison Between T-prf Versus T-prf and Low-level Laser Stimulation on Bone Healing at Posterior Mandibular Fractures (Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in bone density
研究概览
简要总结
Different types of grafting substances have been used in the recent decade to accelerate bone healing at large bony facial defects. PRF was one of the gold standard materials to be used until it was replaced by its successor T-PRF due to the PRF hazards of preparation. However, T-PRF- still can't stand alone in full bone enhancement procedure. Therefore, the combination with another bone bio-modulation technique, like Low-level Laser Therapy, is a must to approach the full advantage of bone healing. Aim: To compare between the effect of using T-PRF versus T-PRF with Low Level Laser stimulation on bone healing at posterior mandibular fractures
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
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from posterior mandibular fracture
排除标准
- •Patients with an untreated old Mandibular fracture.
- •Patient with hematological diseases (thrombocytopenia, hemorrhagic disease, and diabetes).
- •Comminuted fracture with bone loss.
- •There is an infection at the fracture line.
研究组 & 干预措施
T-PRF
干预措施: T-PRF (Other)
T-PRF and LLLT
干预措施: T-PRF and Laser biomodulation (Other)
结局指标
主要结局
Change in bone density
时间窗: Baseline and 3 months
immediate postoperative CT-scan will be performed and compared with another CT-scan done 12 weeks (3 months) later. The on-demand software (OnDemand 3D APP-DBM, Cybermed, Seoul, South Korea) will be used to calculate bone mineral density in Hounsfield Units (HU). Six measurements will be taken along the fracture line, and the mean will be measured for each patient.
Change in mouth opening
时间窗: baseline, 24 hrs, 1 week, 4 weeks, 6 weeks, 12 weeks
With the help of a millimeter ruler, the maximal inter-incisal distance is going to be assessed
Change in wound healing
时间窗: baseline, 24 hrs, 1 week, 4 weeks, 6 weeks, 12 weeks
Early Wound Healing Score (EHS) the following will be assessed and each will be scored from 0 to 2 1. Clinical signs of re-epithelization (CSR) 2. Clinical signs of haemostasias (CSH) 3. Clinical signs of inflammation (CSI)
次要结局
- change in pain scores(24 hrs, 1 week, 4 weeks)
- change in edema(baseline, 24 hrs, 1 week, 4 weeks, 6 weeks, 12 weeks)