Evaluation of the Effects of Dexamethasone-Enriched Platelet-Rich Fibrin on Postoperative Pain, Edema, and Trismus Following Impacted Mandibular Third Molar Surgery: A Randomized Split-Mouth Clinical Trial
Phase: NA
Conditions: Impacted Mandibular Third Molar
Sponsor: Cumhuriyet University

STUDY PROTOCOL 
Title: Evaluation of the Effects of Dexamethasone-Enriched Platelet-Rich Fibrin on 
Postoperative Pain, Edema, and Trismus Following Impacted Mandibular Third Molar 
Surgery: A Randomized Split-Mouth Clinical Trial 
Principal Investigator: Dr. Muhammet Caner Dere 
NCT Number: Not yet assigned. 
Affiliation: Department of Oral and Maxillofacial Surgery, Sivas Cumhuriyet University, 
Faculty of Dentistry, Sivas, Turkey 
Document Date: June 18, 2023 
 
 
 

 
1. Background and Rationale 
Impacted mandibular third molar surgery often results in postoperative pain, swelling, and 
trismus, negatively affecting patient recovery. Platelet-rich fibrin (PRF) has been used to 
improve healing and reduce complications. This study investigates the enhanced effects of 
PRF prepared from blood enriched with dexamethasone, a corticosteroid with anti-
inflammatory properties. 
2. Objectives 
• 
Primary Objective: To assess the effect of dexamethasone-enriched PRF on 
postoperative pain after mandibular third molar extraction. 
• 
Secondary Objectives: To evaluate effects on postoperative edema, trismus, and 
analgesic consumption. 
3. Study Design 
A randomized, controlled, double-blind, split-mouth clinical trial. Each patient will receive 
both interventions in contralateral extraction sites: standard PRF vs dexamethasone-enriched 
PRF. 
4. Participants 
Inclusion Criteria: 
• 
Healthy adults aged 18–25 years 
• 
Bilateral symmetrical impacted mandibular third molars requiring extraction 
• 
No systemic disease 
• 
Good oral hygiene 
• 
Provided written informed consent 
Exclusion Criteria: 
• 
Systemic or immunological disorders 
• 
Recent corticosteroid or anti-inflammatory use 
• 
Pregnancy or lactation 
• 
Allergies to study medication 
• 
Poor oral hygiene or active oral infections 
• 
Temporomandibular joint disorders affecting mouth opening 
5. Interventions 
• 
Control: PRF prepared from standard venous blood. 
• 
Test: PRF prepared from venous blood mixed with 4 mg dexamethasone sodium 
phosphate prior to centrifugation. 

6. Outcome Measures 
• 
Primary Outcome: Postoperative pain measured by Visual Analog Scale (VAS) at 24, 
48, and 72 hours. 
• 
Secondary Outcomes: Edema, trismus, and analgesic consumption measured on 
postoperative days 1, 3, and 7. 
7. Sample Size 
Sixteen patients (32 extraction sites) based on power calculation. 
8. Statistical Analysis 
SPSS 22.0; Independent samples t-test or Mann–Whitney U test depending on data 
distribution. Significance threshold p < 0.05. 
9. Ethics 
Approved by Sivas Cumhuriyet University Ethics Committee (Approval No: 2023-07/02, 
Date: 18.07.2023). Written informed consent obtained. 
10. Data Confidentiality 
Anonymized data storage, access limited to study personnel, data retained for 5 years.