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

Not Applicable

Completed

• Conditions: Impacted Mandibular Third Molar

• Registration Number: NCT07045350
• Lead Sponsor: Cumhuriyet University

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.

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 Timeline

• Study Start: 2023-07-20
• Primary Completion: 2024-04-25
• Study Completion: 2024-07-23
• Status Verified: 2025-06
• Study First Submitted: 2025-06-18
• Study First Submitted QC: 2025-06-27
• Last Update Submitted: 2025-06-27
• Study First Posted: 2025-07-01
• Last Update Posted: 2025-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Postoperative Pain and Analgesic Consumption	72 hours post-surgery	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.

Secondary Outcome Measures

Name	Time	Method
Postoperative Facial Edema	Postoperative days 1, 3, and 7	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 Trismus	Postoperative days 1, 3, and 7	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.

Trial Locations

Locations (1)

Sivas Cumhuriyet University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery; 🇹🇷 Sivas, Turkey