Comparison of PRF and Corticosteroids in Impacted Third Molar Surgery

NCT07742826 | Recruiting

• 1 other identifier: Final International University
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, randomized interventional study aims to compare the postoperative effects of standard treatment (control), platelet-rich fibrin (PRF), and PRF combined with corticosteroid treatment in patients undergoing impacted mandibular third molar surgery. A total of 60 participants will be randomly assigned to one of three treatment groups according to the study protocol. Postoperative pain, facial swelling, and trismus will be evaluated on postoperative days 1, 2, 3, and 7. The findings of this study are expected to provide evidence regarding the effectiveness of PRF alone and PRF combined with corticosteroid treatment in reducing postoperative complications following impacted mandibular third molar surgery.

Conditions

Impacted Mandibular Third Molar Extraction; Impacted Lower Third Molar; Impacted Wisdom Tooth

Keywords

Third Molar Surgery; Impacted Third Molar; Platelet-Rich Fibrin; Corticosteroids; Postoperative Pain; Facial Swelling; Trismus; Oral Surgery; Postoperative Complications

Outcome Measures

Primary Outcomes (3)

• Postoperative Pain

  Postoperative pain assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable.

  Postoperative Days 1, 2, 3, and 7

• Postoperative Swelling

  Postoperative facial swelling assessed using a flexible measuring tape by recording the linear distances from the tragus to the pogonion (chin point), the tragus to the corner of the mouth, and the lateral canthus of the eye to the angle of the mandible.

  Postoperative Days 1, 2, 3, and 7

• Trismus

  Trismus assessed by measuring the maximum interincisal mouth opening (mm) using a digital caliper.

  Postoperative Days 1, 2, 3, and 7

Study Arms (3)

Standard Postoperative Treatment (Control)

ACTIVE COMPARATOR

Participants receive standard postoperative treatment following impacted mandibular third molar surgery, including amoxicillin/clavulanic acid (Augmentin), paracetamol, and chlorhexidine mouthwash. No platelet-rich fibrin (PRF) or corticosteroid is administered.

Drug: Amoxicillin/Clavulanic Acid; Drug: Paracetamol; Drug: Chlorhexidine

Platelet-Rich Fibrin (PRF)

EXPERIMENTAL

Participants receive platelet-rich fibrin (PRF) placed into the extraction socket in addition to standard postoperative treatment consisting of amoxicillin/clavulanic acid (Augmentin), paracetamol, and chlorhexidine mouthwash following impacted mandibular third molar surgery.

Biological: Platelet-rich fibrin (PRF); Drug: Amoxicillin/Clavulanic Acid; Drug: Paracetamol; Drug: Chlorhexidine

Platelet-Rich Fibrin Plus Corticosteroid

EXPERIMENTAL

Participants receive platelet-rich fibrin (PRF) placement into the extraction socket followed by intramuscular corticosteroid administration, in addition to standard postoperative treatment consisting of amoxicillin/clavulanic acid (Augmentin), paracetamol, and chlorhexidine mouthwash following impacted mandibular third molar surgery.

Biological: Platelet-rich fibrin (PRF); Drug: Dexamethasone; Drug: Amoxicillin/Clavulanic Acid; Drug: Paracetamol; Drug: Chlorhexidine

Interventions

Platelet-rich fibrin (PRF) BIOLOGICAL

Autologous platelet-rich fibrin (PRF) prepared from the participant's venous blood by centrifugation at 3000 rpm for 10 minutes, and then placed into the extraction socket immediately after impacted mandibular third molar surgery.

Platelet-Rich Fibrin (PRF); Platelet-Rich Fibrin Plus Corticosteroid

Dexamethasone DRUG

Dexamethasone (8 mg/2 mL) administered as a single intramuscular injection immediately after impacted mandibular third molar surgery in addition to platelet-rich fibrin (PRF), according to the study protocol.

Platelet-Rich Fibrin Plus Corticosteroid

Amoxicillin/Clavulanic Acid DRUG

Amoxicillin/clavulanic acid administered postoperatively according to the study protocol.

Platelet-Rich Fibrin (PRF); Platelet-Rich Fibrin Plus Corticosteroid; Standard Postoperative Treatment (Control)

Paracetamol DRUG

Paracetamol 500 mg tablets administered postoperatively for pain control according to the study protocol.

Platelet-Rich Fibrin (PRF); Platelet-Rich Fibrin Plus Corticosteroid; Standard Postoperative Treatment (Control)

Chlorhexidine DRUG

Chlorhexidine mouthwash administered postoperatively according to the study protocol.

Platelet-Rich Fibrin (PRF); Platelet-Rich Fibrin Plus Corticosteroid; Standard Postoperative Treatment (Control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years and older.
• Patients with good general health
• Patients with complete clinical and radiographic examination (panoramic radiograph/CBCT if applicable)
• Patients willing and able to attend all postoperative follow-up visits

You may not qualify if:

• Patients with systemic diseases that may impair wound healing (e.g., uncontrolled diabetes, immunodeficiency).
• Pregnant or breastfeeding women.
• Patients with acute infection, abscess, or pericoronitis at the surgical site.
• Patients with a history of allergy or contraindication to corticosteroids, local anesthetics, or prescribed medications.
• Patients using corticosteroids, anticoagulants, immunosuppressive drugs, or bisphosphonates.
• Patients with bleeding disorders.
• Patients with previous radiotherapy to the head and neck region.
• Patients unable or unwilling to comply with the study protocol or attend follow-up visits.

Sponsors & Collaborators

• Final International University: lead

Study Sites (1)

Final International University Faculty of Dentistry

Nicosia, 2323, Cyprus

RECRUITING

Related Publications (2)

• Donmezer CM, Bilginaylar K. Comparison of the Postoperative Effects of Local Antibiotic versus Systemic Antibiotic with the Use of Platelet-Rich Fibrin on Impacted Mandibular Third Molar Surgery: A Randomized Split-Mouth Study. Biomed Res Int. 2021 Dec 2;2021:3040661. doi: 10.1155/2021/3040661. eCollection 2021.

  PMID: 34901267 BACKGROUND

• Koc O, Er N, Karaca C, Bilginaylar K. Comparison of the effects of submucosal hyaluronidase and dexamethasone on postoperative edema, pain, trismus, and infection following impacted third molar surgery. BMC Oral Health. 2024 Aug 30;24(1):1018. doi: 10.1186/s12903-024-04729-1.

  PMID: 39215323 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Trismus; Postoperative Complications

Interventions

Dexamethasone; Amoxicillin-Potassium Clavulanate Combination; Acetaminophen; Chlorhexidine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Acetanilides; Anilides; Aniline Compounds; Amines; Biguanides; Guanidines; Amidines

Central Study Contacts

Meliz Kneebone, DDS

CONTACT

+905338425731; meliz-95@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants were randomly assigned to one of the three study groups by a dice roll. The operating surgeon was informed of the treatment allocation immediately before surgery to perform the assigned intervention. Postoperative outcome assessments were performed by a single independent examiner, who was different from the operating surgeon and remained the same examiner throughout the study. The outcome assessor was blinded to the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Researcher in Oral Surgery

Model Details: Participants are randomly assigned by a simple randomization method (dice roll) to one of three parallel groups: a control group receiving standard treatment, a platelet-rich fibrin (PRF) group, or a PRF combined with corticosteroid group. Each participant receives only the intervention assigned at enrollment, and postoperative outcomes are compared between the groups.

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 3, 2026
• Study Start: September 3, 2024
• Primary Completion: August 1, 2026
• Study Completion: August 1, 2026
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)