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Effects of Platelet-Rich Fibrin After Mandibular Third Molar Surgery in Smokers and Nonsmokers

2026年5月17日 更新者:Mehmet Alp Eriş、Ankara University

Effects of Platelet-Rich Fibrin on Postoperative Pain, Trismus and Swelling After Impacted Mandibular Third Molar Surgery in Smokers and Nonsmokers: A Prospective Clinical Study

Mandibular third molar surgery is commonly associated with postoperative pain, swelling, and trismus. Platelet-rich fibrin (PRF) has been proposed as a biological adjunct to improve postoperative healing; however, its effectiveness in smokers remains unclear. This prospective randomized split-mouth clinical study aimed to evaluate the effects of PRF on postoperative pain, swelling, trismus, and analgesic consumption after impacted mandibular third molar surgery in smokers and nonsmokers. Thirty patients with bilaterally impacted mandibular third molars were included. PRF was placed in one extraction socket, while the contralateral socket served as the control site. Postoperative clinical outcomes were assessed during the first postoperative week and compared between smoking and nonsmoking patients.

研究概览

详细说明

This prospective randomized split-mouth clinical trial was conducted between 2017 and 2019 at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Ankara University. The study aimed to evaluate the effects of platelet-rich fibrin (PRF) on postoperative pain, swelling, trismus, and analgesic consumption after impacted mandibular third molar surgery in smoking and nonsmoking patients.

A total of 30 systemically healthy patients aged 18-35 years with bilaterally impacted mandibular third molars were included. Patients were divided into smoking and nonsmoking groups. In each patient, PRF was randomly applied to one extraction socket, while the contralateral socket served as the control site without PRF application. All surgical procedures were performed by the same oral and maxillofacial surgeon using a standardized surgical protocol. Outcome assessments were performed by a different clinician blinded to the intervention side.

Postoperative pain was evaluated using a visual analog scale (VAS). Facial swelling was assessed using linear facial measurements between anatomical landmarks, and trismus was evaluated by measuring maximum interincisal distance. Clinical evaluations were performed preoperatively and on postoperative days 1, 2, 3, and 7.

The primary outcome of the study was postoperative pain intensity. Secondary outcomes included postoperative swelling, trismus, and analgesic consumption. The study also aimed to compare the clinical effectiveness of PRF between smokers and nonsmokers.

研究类型

介入性

注册 (实际的)

30

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • Systemically healthy patients aged between 18 and 35 years
  • Bilaterally impacted mandibular third molars
  • Mandibular third molars classified as Pell and Gregory Class I, Position C
  • Mandibular third molars classified as Parant Class II difficulty
  • Smoking and nonsmoking patients
  • Patients willing to participate and provide written informed consent

Exclusion Criteria:

  • Presence of acute infection or pericoronitis
  • Pregnancy or lactation
  • Alcohol or substance abuse
  • Use of oral contraceptives
  • Menstrual period during surgery
  • Antibiotic use within the previous month
  • Smoking more than 10 cigarettes per day
  • Agitation or inability to cooperate
  • Incomplete follow-up data
  • Systemic disease contraindicating oral surgery

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:PRF-treated socket
Platelet-rich fibrin (PRF) was placed into the extraction socket following impacted mandibular third molar surgery.
Autologous platelet-rich fibrin prepared from venous blood by centrifugation and placed into the extraction socket after mandibular third molar extraction.
无干预:Control socket
The contralateral extraction socket was primarily closed without PRF application after mandibular third molar surgery.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Postoperative Pain Intensity
大体时间:Postoperative days 1, 2, 3, and 7
Postoperative pain intensity assessed using a 100-mm visual analog scale (VAS) after impacted mandibular third molar surgery.
Postoperative days 1, 2, 3, and 7

次要结果测量

结果测量
措施说明
大体时间
Postoperative Facial Swelling
大体时间:Preoperative period and postoperative days 1, 2, 3, and 7
Postoperative facial swelling assessed using linear facial measurements between anatomical landmarks.
Preoperative period and postoperative days 1, 2, 3, and 7
Postoperative Trismus
大体时间:Preoperative period and postoperative days 1, 2, 3, and 7
Trismus assessed by measuring maximum interincisal mouth opening distance.
Preoperative period and postoperative days 1, 2, 3, and 7
Postoperative Analgesic Consumption
大体时间:Postoperative days 1, 2, 3, and 7
Number of analgesic tablets used during the postoperative follow-up period.
Postoperative days 1, 2, 3, and 7

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Mehmet Emre Yurttutan, PhD, DDS、Ankara University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年5月15日

初级完成 (实际的)

2018年12月21日

研究完成 (实际的)

2018年12月21日

研究注册日期

首次提交

2026年5月17日

首先提交符合 QC 标准的

2026年5月17日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年5月22日

上次提交的符合 QC 标准的更新

2026年5月17日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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