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

NCT ID: NCT07045350

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-20
• Study Completion Date: 2024-07-23

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.

Conditions

Impacted Mandibular Third Molar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Control - Standard PRF

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

Group Type: ACTIVE_COMPARATOR

Platelet-rich fibrin (PRF)

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Platelet-rich fibrin (PRF)

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Dexamethasone-Enriched Platelet-Rich Fibrin

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cumhuriyet University

OTHER

Sponsor Role: lead

Responsible Party

Muhammet Caner Dere

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muhammet Caner Dere, DDS

Role: PRINCIPAL_INVESTIGATOR

Sivas Cumhuriyet University, Faculty of Dentistry

Locations

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

Sivas, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

DIS-2024-328

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SCU-EC-No: 2023-07/02

Identifier Type: -

Identifier Source: org_study_id