Evaluation of the Effects of Platelet-rich Plasma and Concentrated Growth Factor on Postoperative Pain, Swelling, and Alveolar Osteitis After Mandibular Third Molar Surgery: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Postoperative Pain
研究概览
简要总结
This study evaluates the effects of two different blood products obtained from the patient's own blood (Concentrated Growth Factor [CGF] and Platelet-Rich Plasma [PRP]) on healing after wisdom tooth extraction. The aim is to determine whether applying these materials to the extraction area reduces postoperative pain, facial swelling, and the risk of dry socket compared to standard healing.
详细描述
This prospective, randomized, controlled clinical trial compares the efficacy of autologous platelet concentrates in reducing postoperative sequelae following the surgical extraction of impacted mandibular third molars.
A total of 42 patients were randomly assigned to one of three groups:
Control Group: Standard surgical extraction without additional biomaterials.
CGF Group: Standard extraction followed by the placement of a CGF clot into the extraction socket.
PRP Group: Standard extraction followed by submucosal injection of PRP.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 50 years.
- •Systemically healthy individuals classified as American Society of Anesthesiologists (ASA) Class I or Class II.
- •Presence of impacted mandibular third molars (teeth 38 and 48 according to Fédération Dentaire Internationale (FDI) notation).
- •Mesioangular impaction with bone retention according to Winter's classification.
- •Class II relationship to the ramus according to the Pell and Gregory classification.
- •Level B or Level C depth of impaction according to the Pell and Gregory classification.
排除标准
- •Patients younger than 18 years.
- •Habitual smoking or alcohol consumption.
- •Presence of coagulation (bleeding) disorders.
- •Systemic diseases affecting wound healing or use of medications that compromise healing.
- •Pregnancy or lactation.
- •Presence of active pericoronitis associated with the tooth.
- •Presence of pathological lesions (cysts or tumors) associated with the impacted tooth.
- •Uncontrolled periodontal disease in the oral cavity.
- •Known allergy to any medications used in the study protocol.
- •Inability to comply with follow-up visits.
研究组 & 干预措施
CGF Group
Standard surgical extraction followed by the placement of a Concentrated Growth Factor (CGF) clot into the extraction socket.
干预措施: Concentrated Growth Factor (CGF) (Biological)
PRP Group
Standard surgical extraction followed by submucosal injection of Platelet-Rich Plasma (PRP).
干预措施: Platelet-Rich Plasma (PRP) (Biological)
Control Group
Standard surgical extraction was performed without the application of any additional biomaterials.
结局指标
主要结局
Postoperative Pain
时间窗: Postoperative days 1, 3, and 7.
Assessed using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable).
次要结局
- Incidence of Alveolar Osteitis(Postoperative days 1, 3, and 7)
- Facial Swelling(Preoperative and Postoperative days 1, 3, and 7.)
研究者
Emin Valiyev
Principal Investigator
Recep Tayyip Erdogan University