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

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

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.

Study Overview

• Status: Completed
• Conditions: Impacted Mandibular Third Molar
• Intervention / Treatment: Procedure: Platelet-rich fibrin (PRF)

Detailed Description

Detailed Description

Background:

Third molar (wisdom tooth) extraction is a common oral surgical procedure often associated with postoperative inflammatory complications such as pain, edema, and trismus, which can significantly reduce patient quality of life. Platelet-rich fibrin (PRF) has been used to enhance healing and reduce postoperative morbidity. Dexamethasone is a corticosteroid known for its potent anti-inflammatory effects. This study evaluates whether PRF prepared from dexamethasone-enriched blood can improve postoperative outcomes compared to standard PRF.

Objectives:

The primary objective is to assess the effect of dexamethasone-enriched PRF on postoperative pain following impacted mandibular third molar extraction. Secondary objectives include evaluation of edema, trismus, and analgesic consumption.

Study Design:

This is a randomized, controlled, split-mouth, double-blind clinical trial conducted in a single center. Sixteen patients with bilateral symmetrical impacted mandibular third molars requiring extraction were enrolled. Each patient received two different treatments: one socket treated with standard PRF and the contralateral socket treated with dexamethasone-enriched PRF.

Participants:

Eligible patients were aged 18-25 years, in good systemic health, with no contraindications for oral surgery or corticosteroid use. Exclusion criteria included systemic diseases, pregnancy or lactation, hypersensitivity to corticosteroids, poor oral hygiene, recent corticosteroid therapy, and temporomandibular joint disorders.

Intervention:

Peripheral venous blood was drawn from each patient, with dexamethasone added to one sample prior to centrifugation to prepare the test PRF. The control PRF was prepared without dexamethasone. PRF clots were applied immediately into the extraction sockets after tooth removal.

Outcome Measures:

Postoperative pain was measured using a visual analog scale (VAS) at 24, 48, and 72 hours. Edema and trismus were evaluated on postoperative days 1, 3, and 7. Analgesic intake was recorded throughout the postoperative period. Data were analyzed with appropriate statistical tests considering p < 0.05 as significant.

Ethical Considerations:

The study was approved by the institutional ethics committee (approval number XXXX), and written informed consent was obtained from all participants. The study complied with the Declaration of Helsinki guidelines.

Significance:

Findings from this study may provide evidence for a novel, autologous drug delivery method to reduce postoperative morbidity after mandibular third molar surgery, potentially improving patient comfort and clinical outcomes.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Sivas, Turkey, 58140
    • Sivas Cumhuriyet University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control - Standard PRF; Application of standard platelet-rich fibrin (PRF) prepared from blood without dexamethasone to the mandibular third molar extraction site.	Procedure: Platelet-rich fibrin (PRF); 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.; Other Names: Dexamethasone-Enriched Platelet-Rich Fibrin
Experimental: Test - Dexamethasone-enriched PRF; 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); 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.; Other Names: Dexamethasone-Enriched Platelet-Rich Fibrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Facial Edema	Facial swelling will be evaluated by measuring linear distances between predefined facial landmarks (tragus-commissure, tragus-pogonion, lateral canthus-gonion) on postoperative days 1, 3, and 7.	Postoperative days 1, 3, and 7
Postoperative Trismus	Maximum interincisal mouth opening (in millimeters) will be measured preoperatively and on postoperative days 1, 3, and 7 using a digital caliper to assess trismus severity.	Postoperative days 1, 3, and 7

Collaborators and Investigators

• Sponsor: Cumhuriyet University
• Investigators: Principal Investigator: Muhammet Caner Dere, DDS, Sivas Cumhuriyet University, Faculty of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2023
• Primary Completion (Actual): April 25, 2024
• Study Completion (Actual): July 23, 2024

Study Registration Dates

• First Submitted: June 18, 2025
• First Submitted That Met QC Criteria: June 27, 2025
• First Posted (Estimated): July 1, 2025

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 27, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Pain; Edema; Dexamethasone; Platelet Rich Fibrin; Third molar; Trismus
• Additional Relevant MeSH Terms: Neurologic Manifestations; Stomatognathic Diseases; Nervous System Diseases; Neuromuscular Manifestations; Tooth Diseases; Spasm; Trismus; Tooth, Impacted; Antineoplastic Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: SCU-EC-No: 2023-07/02; DIS-2024-328 (Other Grant/Funding Number: CÜBAP, Sivas Cumhuriyet University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The datasets generated during and/or analysed during the current study will be available upon request from the corresponding author (Dr. Muhammet Caner Dere, caner_1995@hotmail.com). The shared data will include anonymized individual participant data related to postoperative pain, edema, trismus, and analgesic use. Data will be available after study completion and publication, for a period of 5 years. The data will be shared for scientific research and meta-analyses, subject to ethics committee approval and a data use agreement. Participants' informed consent included agreement for anonymized data sharing.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No