Evaluation of the Effects of Platelet-Rich Fibrin on Postoperative Pain, Trismus, and Edema Following Surgical Removal of Mandibular Third Molars
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Postoperative Pain
研究概览
简要总结
Impacted mandibular third molars are among the most commonly encountered conditions in oral and maxillofacial surgery. Surgical removal of these teeth is frequently associated with postoperative complications such as pain, facial swelling, and trismus, which may affect patients' daily activities and quality of life.
Platelet-rich fibrin (PRF) is an autologous platelet concentrate prepared from the patient's own blood and contains various growth factors that may promote wound healing and reduce postoperative inflammation. The present randomized controlled trial aims to evaluate the effectiveness of PRF in reducing postoperative pain, trismus, and facial swelling after surgical removal of mandibular third molars.
Participants with impacted mandibular third molars meeting the eligibility criteria will be randomly allocated into two groups. The intervention group will receive PRF placement in the extraction socket, while the control group will receive sterile absorbable gelatin sponge (Gelfoam) after tooth removal. Postoperative pain, mouth opening, and facial swelling will be assessed preoperatively and on the first and seventh postoperative days.
The findings of this study may help determine whether PRF improves postoperative recovery following mandibular third molar surgery.
详细描述
Impacted mandibular third molars frequently require surgical removal and represent one of the most commonly performed procedures in oral and maxillofacial surgery. Postoperative complications such as pain, facial swelling, and trismus commonly occur following surgical extraction and may negatively affect oral function and quality of life.
Various approaches have been proposed to reduce postoperative morbidity, including nonsteroidal anti-inflammatory drugs, corticosteroids, cold therapy, hyaluronic acid, and other adjunctive methods. Platelet-rich fibrin (PRF) is a second-generation autologous platelet concentrate that contains a fibrin matrix enriched with platelets, leukocytes, cytokines, and growth factors. These biological mediators contribute to angiogenesis, tissue regeneration, collagen synthesis, and wound healing.
The purpose of this randomized controlled trial is to evaluate the effects of platelet-rich fibrin on postoperative pain, trismus, and facial swelling following surgical removal of mandibular third molars.
Eligible participants aged 18 to 50 years with impacted mandibular third molars fulfilling the inclusion criteria will be recruited from the Department of Oral and Maxillofacial Surgery, Pakistan Atomic Energy Commission General Hospital, Islamabad. After obtaining written informed consent, participants will be randomly assigned to one of two groups:
PRF group: Platelet-rich fibrin will be prepared from the patient's venous blood and placed into the extraction socket before wound closure.
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)
盲法说明
The investigator responsible for recording postoperative pain, trismus, and facial swelling will be blinded to the treatment allocation to minimize assessment bias.
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 18 to 50 years Patients with impacted mandibular third molars indicated for surgical extraction Mesioangular or vertical impactions (Winter classification) Class II or Class III impactions, Position B or C (Pell and Gregory classification) Patients who provide written informed consent
排除标准
- •Pregnant or lactating females Patients with systemic diseases affecting healing (e.g., uncontrolled diabetes, immunocompromised states) Smokers Patients on medications affecting bone or soft tissue healing Patients with acute infection at the surgical site
研究组 & 干预措施
Platelet-Rich Fibrin (PRF) Group
Participants undergoing surgical removal of impacted mandibular third molars will receive platelet-rich fibrin (PRF) prepared from autologous venous blood and placed into the extraction socket before wound closure. Standard postoperative medications and instructions will be provided.
干预措施: Platelet-rich fibrin (PRF) (Biological)
Gelfoam Control Group
Participants undergoing surgical removal of impacted mandibular third molars will receive sterile absorbable gelatin sponge (Gelfoam) placed into the extraction socket before wound closure. Standard postoperative medications and instructions will be provided.
干预措施: Sterile Absorbable Gelatin Sponge (Device)
结局指标
主要结局
Postoperative Pain
时间窗: Preoperative baseline, postoperative day 1, and postoperative day 7
Postoperative pain will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be recorded and compared between the platelet-rich fibrin and Gelfoam groups.
Postoperative Trismus
时间窗: Preoperative baseline, postoperative day 1, and postoperative day 7
Trismus will be assessed by measuring the maximum interincisal opening in millimeters using a vernier caliper. The distance between the upper and lower central incisors at maximum mouth opening will be recorded and compared between the study groups.
Postoperative Facial Swelling (Edema)
时间窗: Preoperative baseline, postoperative day 1, and postoperative day 7
Facial swelling will be assessed using linear facial measurements taken with a measuring tape. Measurements will include the distance between the angle of the mandible and lateral canthus of the eye, tragus to corner of the mouth, and tragus to soft tissue pogonion. The average of these measurements will be used to calculate facial dimension and assess postoperative edema. Values will be compared between the platelet-rich fibrin and Gelfoam groups.
次要结局
未报告次要终点
研究者
Dr. Sumbal Tariq
Doctor
PAEC General Hospital, Islamabad