Dexamethasone-PRF in Mandibular Third Molar Surgery: Effect on Pain, Edema, and Trismus (DEXPRF-3M)

NCT07045350 | Completed

• 2 other identifiers: SCU-EC-No: 2023-07/02DIS-2024-328
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Brief Summary This clinical trial investigates the effects of platelet-rich fibrin (PRF) derived from dexamethasone-enriched blood on postoperative recovery following the surgical extraction of impacted mandibular third molars (wisdom teeth). The study aims to determine whether the addition of dexamethasone, a potent anti-inflammatory medication, to the blood used for PRF preparation can reduce postoperative pain, swelling, and limited mouth opening (trismus) more effectively than standard PRF. The study is designed as a randomized, split-mouth, double-blind clinical trial involving 16 patients who require bilateral extraction of impacted lower third molars. Each patient receives both treatments: one extraction socket treated with standard PRF and the other with dexamethasone-enriched PRF. Postoperative outcomes including pain intensity, edema, trismus, and analgesic consumption are recorded and analyzed. The results of this study could offer a safer and more effective method for managing discomfort after wisdom tooth removal, potentially improving patient quality of life and reducing the need for additional medications.

Conditions

Impacted Mandibular Third Molar

Keywords

Third molar; Platelet Rich Fibrin; Dexamethasone; Edema; Pain; Trismus

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain and Analgesic Consumption

  Measurement of postoperative pain using the Visual Analog Scale (VAS; range 0-10, where 0 indicates no pain and 10 indicates the worst imaginable pain) and total analgesic intake at 24, 48, and 72 hours after mandibular third molar extraction.

  72 hours post-surgery

Secondary Outcomes (2)

• Postoperative Facial Edema

  Postoperative days 1, 3, and 7

• Postoperative Trismus

  Postoperative days 1, 3, and 7

Study Arms (2)

Control - Standard PRF

ACTIVE COMPARATOR

Application of standard platelet-rich fibrin (PRF) prepared from blood without dexamethasone to the mandibular third molar extraction site.

Procedure: Platelet-rich fibrin (PRF)

Test - Dexamethasone-enriched PRF

EXPERIMENTAL

Application of platelet-rich fibrin (PRF) prepared from blood enriched with 4 mg dexamethasone to the mandibular third molar extraction site.

Procedure: Platelet-rich fibrin (PRF)

Interventions

Platelet-rich fibrin (PRF) PROCEDURE

Application of autologous platelet-rich fibrin (PRF) prepared from peripheral blood with or without the addition of 4 mg dexamethasone directly into the blood collection tube prior to centrifugation. PRF was applied into the extraction socket after impacted mandibular third molar surgery. The test group received PRF prepared from blood enriched with dexamethasone, while the control group received standard PRF without dexamethasone, to evaluate postoperative pain, edema, and trismus.

Also known as: Dexamethasone-Enriched Platelet-Rich Fibrin

Control - Standard PRF; Test - Dexamethasone-enriched PRF

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged between 18 and 25 years.
• Presence of bilateral, symmetrical, bone-retained impacted mandibular third molars requiring extraction.
• Systemically healthy individuals with no chronic medical conditions.
• Good oral hygiene and healthy periodontal status.
• Radiographically confirmed bilateral similarity of impacted third molars.
• Patients willing to participate and who provided written informed consent.

You may not qualify if:

• Presence of systemic diseases or conditions that may affect wound healing.
• Regular use of prescription medications.
• Pregnant or lactating individuals, or those with suspected pregnancy.
• Known allergy or hypersensitivity to dexamethasone or related compounds.
• Poor oral hygiene or active periodontal disease.
• Presence of fungal, viral, or bacterial infection either systemically or locally.
• History of corticosteroid use within the past month.
• Temporomandibular joint disorders affecting mouth opening.

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (1)

Sivas Cumhuriyet University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery

Sivas, 58140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Edema; Pain; Trismus

Condition Hierarchy (Ancestors)

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

Study Officials

• Muhammet Caner Dere, DDS

  Sivas Cumhuriyet University, Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both participants and clinicians performing postoperative evaluations were blinded to the treatment allocation. This was done to minimize bias in reporting and assessment of postoperative pain, edema, and trismus.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: This randomized controlled clinical trial uses a split-mouth design, where each patient serves as their own control. One side receives platelet-rich fibrin (PRF) from dexamethasone-enriched blood, while the contralateral side receives standard PRF to compare postoperative outcomes.

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: July 1, 2025
• Study Start: July 20, 2023
• Primary Completion: April 25, 2024
• Study Completion: July 23, 2024
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The individual participant data (IPD) and supporting materials will be available from 6 months after publication of the final results and for a period of 5 years.
• Access Criteria: Researchers who provide a methodologically sound proposal will be granted access to anonymized individual participant data (IPD), including postoperative pain scores, edema, trismus measurements, and analgesic intake. Access will be provided for the purpose of scientific research or meta-analyses, subject to approval by an ethics committee and after signing a data use agreement. Data will be available by contacting the corresponding author.

Locations

TU (1)