Comparative study on effects of A-PRF and S-PRF on pain edema trismus soft tissue healing and bone healing following impacted lower third molar extraction-A randomized control trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.Postoperative pain will be measured using a visual analogue scale (VAS).
研究概览
简要总结
Removal of the impacted third molars is the most common surgical procedure performed in outpatient setting. This procedure may be associated with considerable postoperative complications including pain, trismus, edema, surgical site infection as well as alveolar osteitis. To date numerous methods such as utilization of pharmacologic agents including corticosteroids, nonsteroidal anti-inflammatory drugs, hyaluronic acid, cold therapy, and piezo-electric deviceshave been used in an attempt to accelerate wound healing and prevent post-operative complications. However, the most effective method that provides optimum control in the post-operative period is still under debate.
Platelet concentrates acts as an immune regulator and may decrease the deleterious effects of inflammationas mentioned by Dohan et al. Advanced platelet-rich fibrin (A-PRF) a new formulation of PRF introduced by Choukroun showed a looser structure with more inter-fibrous space and more cells could be counted in the fibrin-rich clot. Furthermore, the cells were more evenly distributed throughout the clot, as compared to S-PRF, and some cells could even be found in the clot’s more distal parts. A-PRF had a greater number of leukocyte and platelet as well as growth factors(VEGF and TGF-β1).Several clinical studies which explore the effect of PRF on postoperative sequelae following third molar surgery have shown promising effects of PRF on reducing post-operative oedema, trismus and pain ,few studies have been conducted on the efficacy of PRF and its modified forms on ossification of bone defects created by removal of teeth, however a lacuna exists on the use of PRF and its modified formson soft tissue and bony healing following impacted third molar extractions
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy patients without significant medical diseases or a history of bleeding problems.
- •2.The third molars had to be in the Class I, Level A position (according to Pell &Gregory) 3.Impacted teeth to be in the mesioangular position according to Winter.
排除标准
- •1.Pregnant and lactating women 2.Patients with signs of pericoronitis 3.Patients with chronic use of medications such as antihistamines, non steroidal anti inflammatory drugs (NSAID, steroids and antidepressants which would complicate the evaluation of their postoperative response.
结局指标
主要结局
1.Postoperative pain will be measured using a visual analogue scale (VAS).
时间窗: 1.Post Operative pain will be assessed at day 1, day 3 and day 7. | 2.Post Operative swelling will be assessed at day 1, day 3 and day 7. | 3.Post Operative trismus will be assessed at postoperative day 1, day 3 and day 7. | 4.Soft tissue healing will be assessed on Postoperative Day 7. | 5.Bone healing radiographically will be assessed on postoperative 1 month, 3 months and 6 months
2.Soft tissue healing will be assessed based on Landry and Turnbull scale.
时间窗: 1.Post Operative pain will be assessed at day 1, day 3 and day 7. | 2.Post Operative swelling will be assessed at day 1, day 3 and day 7. | 3.Post Operative trismus will be assessed at postoperative day 1, day 3 and day 7. | 4.Soft tissue healing will be assessed on Postoperative Day 7. | 5.Bone healing radiographically will be assessed on postoperative 1 month, 3 months and 6 months
3.Trismus will be evaluated by measuring the distance between incisal edges of upper and lower central incisor at maximal mouth opening.
时间窗: 1.Post Operative pain will be assessed at day 1, day 3 and day 7. | 2.Post Operative swelling will be assessed at day 1, day 3 and day 7. | 3.Post Operative trismus will be assessed at postoperative day 1, day 3 and day 7. | 4.Soft tissue healing will be assessed on Postoperative Day 7. | 5.Bone healing radiographically will be assessed on postoperative 1 month, 3 months and 6 months
4.Bone healing of the third molar socket will be assessed radiographically using an OPG/IOPAR.
时间窗: 1.Post Operative pain will be assessed at day 1, day 3 and day 7. | 2.Post Operative swelling will be assessed at day 1, day 3 and day 7. | 3.Post Operative trismus will be assessed at postoperative day 1, day 3 and day 7. | 4.Soft tissue healing will be assessed on Postoperative Day 7. | 5.Bone healing radiographically will be assessed on postoperative 1 month, 3 months and 6 months
5.Post-operative swelling will be assessed.
时间窗: 1.Post Operative pain will be assessed at day 1, day 3 and day 7. | 2.Post Operative swelling will be assessed at day 1, day 3 and day 7. | 3.Post Operative trismus will be assessed at postoperative day 1, day 3 and day 7. | 4.Soft tissue healing will be assessed on Postoperative Day 7. | 5.Bone healing radiographically will be assessed on postoperative 1 month, 3 months and 6 months
次要结局
- The presence of alveolar osteitis will be assessed on the basis of clinical examination and subjective symptoms reported by the patient.(Assessment for alveolar osteitis will be done clinically at postoperative day 3 and 7.)
研究者
VELOOR MANI BALAJI
GOVERNMENT DENTAL COLLEGE AND RESEARCH INSTITUTE ,BANGALORE