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Clinical Trials/NCT07604584
NCT07604584CompletedNot Applicable

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

Ankara University1 site in 1 country30 target enrollmentStarted: May 15, 2017Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mehmet Alp Eriş

Research Assistant

Ankara University

Study Sites (1)

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