Effect of Platelet-Rich Fibrin on Postoperative Pain, Trismus, and Edema After Mandibular Third Molar Surgery (PRF-M3M)

June 22, 2026 updated by: Dr. Sumbal Tariq, PAEC General Hospital, Islamabad

Evaluation of the Effects of Platelet-Rich Fibrin on Postoperative Pain, Trismus, and Edema Following Surgical Removal of Mandibular Third Molars

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Control group: Sterile absorbable gelatin sponge (Gelfoam) will be placed into the extraction socket before wound closure.

Standardized surgical procedures, local anesthesia, medications, and postoperative instructions will be provided to all participants.

Outcome measures will include:

Postoperative pain assessed using the Visual Analog Scale (VAS). Trismus assessed by maximum interincisal opening measured in millimeters. Facial swelling assessed using standardized facial measurements. Measurements will be recorded preoperatively and on postoperative days 1 and 7.

The primary outcomes are postoperative pain and trismus, while facial swelling is considered a secondary outcome. Statistical analysis will compare outcomes between the two groups to determine whether PRF improves postoperative recovery after mandibular third molar surgery.

Study Type

Interventional

Enrollment (Actual)

134

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Federal
      • Islamabad, Federal, Pakistan, 44100
        • PAEC General Hospital, Islamabad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Biological: Platelet-rich fibrin (PRF)
Platelet-rich fibrin (PRF) will be prepared from 10 mL of autologous venous blood collected from the participant. The blood sample will be centrifuged at 2700 rpm for 12 minutes to obtain the fibrin clot. Following surgical extraction of the mandibular third molar, the PRF clot will be placed into the extraction socket before wound closure.
Active Comparator: 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.
Device: Sterile Absorbable Gelatin Sponge
Following surgical extraction of the mandibular third molar, a sterile absorbable gelatin sponge (Gelfoam) will be placed into the extraction socket before wound closure. Standard postoperative medications and instructions will be provided to all participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain
Time Frame: 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.
Preoperative baseline, postoperative day 1, and postoperative day 7
Postoperative Trismus
Time Frame: 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.
Preoperative baseline, postoperative day 1, and postoperative day 7
Postoperative Facial Swelling (Edema)
Time Frame: 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.
Preoperative baseline, postoperative day 1, and postoperative day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PAEC General Hospital, Islamabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2025

Primary Completion (Actual)

May 16, 2026

Study Completion (Actual)

May 22, 2026

Study Registration Dates

First Submitted

June 22, 2026

First Submitted That Met QC Criteria

June 22, 2026

First Posted (Actual)

June 29, 2026

Study Record Updates

Last Update Posted (Actual)

June 29, 2026

Last Update Submitted That Met QC Criteria

June 22, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMFS-PRF-2026-01
  • PAEC (Registry Identifier: PAEC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not required

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Pain

Clinical Trials on Platelet-rich fibrin (PRF)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe