Clinical Investigation of the Effects of Concentrated Growth Factor (CGF) and Advanced Platelet Rich Fibrin (A-PRF) on Pain, Edema and Trismus After Impacted Lower Third Molar Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Edema-amount change of swelling
研究概览
简要总结
The objective of this case-control intervention study is to explore the effectiveness of Concentrated Growth Factor (CGF) and Advanced Platelet Rich Fibrin (A-PRF) on Pain, Edema and Trismus After Impacted Lower Third Molar Surgery
详细描述
In the present study, 75 patient, whose ages ranged between 18-30 and have an impacted lower third molar which is in vertical or mesiyoangular position and has class I and II ramus relationship and class B and C depth, will included. 75 patient will divided randomly into three groups as CGF, A-PRF and Control. After third molar surgery CGF and A-PRF will prepared and applied to the extraction sockets in CGF and A-PRF groups. nothing will applied to the control group. Post operative pain, edema and trismus will measured at 2nd and 7th days.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients presenting asymptomatic impacted lower third molar tooth in the vertical or mesioanguler position according to the Winter classification, Class I and II ramus relation and class B and C depth according to Pell-Gregory classification
- •Patients between the ages of 18-30,
- •Non-smokers,
- •Patients with ASA I status
排除标准
- •Who does not want to be volunteer for the study,
- •Do not comply with post-operative recommendations,
- •Operation lasting more than 30 minutes,
- •During pregnancy or lactation,
- •Have a chronic systemic disorder that may affect healing.
- •Unable to cooperate,
- •Post-operative infection,
- •Patients with pericoronitis
研究组 & 干预措施
Concentrated Growth Factor (CGF)
Participants with impacted lower third molar
干预措施: Concentrated Growth Factor (CGF) (Other)
Advanced Platelet Rich Fibrin (A-PRF)
Participants with impacted lower third molar
干预措施: Advanced Platelet Rich Fibrin (A-PRF) (Other)
Control
Participants with impacted lower third molar
干预措施: Control (Other)
结局指标
主要结局
Edema-amount change of swelling
时间窗: Baseline, 2nd and 7th days
In order to evaluate the amount change of swelling after the operation, horizontal and vertical measurements will be made from 5 reference points including tragus, lip corner, soft tissue pogonion, lateral cantus of the eye and gonion. The first measurement between the tragus-lip corner, the second measurement will be obtained by measuring the horizontal distance between the tragus-soft tissue pogonion. The third measurement will be determined by the measurement of the vertical distance between the outer corner of the eye and the gonion. to determine the change in the swelling measurements performed before surgery and at 2nd-7th days after surgery.
次要结局
- Trismus- degree of change (limitation) in maximum mouth opening(Baseline, 2nd and 7th days)
- Post operative Pain: visual analog (VAS) scale(6th and 24th hours, 2nd and 7th days)
- Post-operative symptom severity (PoSSe) scale(Post operative 7th day)
研究者
Dr. Damla Torul
Research Asistant, Oral and Maxillofacial Surgery
T.C. ORDU ÜNİVERSİTESİ