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

NCT07672951 | Completed DMC

• 2 other identifiers: OMFS-PRF-2026-01PAEC
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Impacted Mandibular Third Molar; Postoperative Pain; Trismus; Edema Face

Keywords

Platelet-Rich Fibrin; Mandibular Third Molar; Third Molar Surgery; Postoperative Pain; Trismus; Facial Swelling; Edema

Outcome Measures

Primary Outcomes (3)

• Postoperative Pain

  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

  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)

  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

Study Arms (2)

Platelet-Rich Fibrin (PRF) Group

EXPERIMENTAL

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)

Gelfoam Control Group

ACTIVE COMPARATOR

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

Interventions

Platelet-rich fibrin (PRF) BIOLOGICAL

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.

Platelet-Rich Fibrin (PRF) Group

Sterile Absorbable Gelatin Sponge DEVICE

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.

Gelfoam Control Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PAEC General Hospital, Islamabad: lead

Study Sites (1)

PAEC General Hospital, Islamabad

Islamabad, Federal, 44100, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative; Trismus; Edema

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Spasm; Neuromuscular Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigator responsible for recording postoperative pain, trismus, and facial swelling will be blinded to the treatment allocation to minimize assessment bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Participants will be randomly assigned to one of two parallel groups. The intervention group will receive platelet-rich fibrin (PRF) placed in the extraction socket following mandibular third molar surgery, while the control group will receive sterile absorbable gelatin sponge (Gelfoam). Outcomes will be assessed preoperatively and on postoperative days 1 and 7.

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 29, 2026
• Study Start: December 9, 2025
• Primary Completion: May 16, 2026
• Study Completion: May 22, 2026
• Last Updated: June 29, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)