Health Trials

Comparison of PRF and Corticosteroids in Impacted Third Molar Surgery

ConditionsImpacted Mandibular Third Molar ExtractionImpacted Lower Third MolarImpacted Wisdom Tooth
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFinal International University

About this trial

This prospective, randomized interventional study aims to compare the postoperative effects of standard treatment (control), platelet-rich fibrin (PRF), and PRF combined with corticosteroid treatment in patients undergoing impacted mandibular third molar surgery. A total of 60 participants will be randomly assigned to one of three treatment groups according to the study protocol. Postoperative pain, facial swelling, and trismus will be evaluated on postoperative days 1, 2, 3, and 7. The findings of this study are expected to provide evidence regarding the effectiveness of PRF alone and PRF combined with corticosteroid treatment in reducing postoperative complications following impacted mandibular third molar surgery.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients aged 18 years and older.

Patients with good general health

Patients with complete clinical and radiographic examination (panoramic radiograph/CBCT if applicable)

Patients willing and able to attend all postoperative follow-up visits

Disqualifiers

Patients with systemic diseases that may impair wound healing (e.g., uncontrolled diabetes, immunodeficiency).

Pregnant or breastfeeding women.

Patients with acute infection, abscess, or pericoronitis at the surgical site.

Patients with a history of allergy or contraindication to corticosteroids, local anesthetics, or prescribed medications.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Platelet-rich fibrin (PRF)

    Biological/Vaccine

    Autologous platelet-rich fibrin (PRF) prepared from the participant's venous blood by centrifugation at 3000 rpm for 10 minutes, and then placed into the extraction socket immediately after impacted mandibular third molar surgery.

  • Dexamethasone

    Drug

    Dexamethasone (8 mg/2 mL) administered as a single intramuscular injection immediately after impacted mandibular third molar surgery in addition to platelet-rich fibrin (PRF), according to the study protocol.

  • Amoxicillin/Clavulanic Acid

    Drug

    Amoxicillin/clavulanic acid administered postoperatively according to the study protocol.

  • Paracetamol

    Drug

    Paracetamol 500 mg tablets administered postoperatively for pain control according to the study protocol.

  • Chlorhexidine

    Drug

    Chlorhexidine mouthwash administered postoperatively according to the study protocol.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Standard Postoperative Treatment (Control)Active comparator 3 interventions
Group B: Platelet-Rich Fibrin (PRF)Experimental treatment 4 interventions
Group C: Platelet-Rich Fibrin Plus CorticosteroidExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Postoperative Pain

Postoperative pain assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable.

Time frame
Postoperative Days 1, 2, 3, and 7
2

Postoperative Swelling

Postoperative facial swelling assessed using a flexible measuring tape by recording the linear distances from the tragus to the pogonion (chin point), the tragus to the corner of the mouth, and the lateral canthus of the eye to the angle of the mandible.

Time frame
Postoperative Days 1, 2, 3, and 7
3

Trismus

Trismus assessed by measuring the maximum interincisal mouth opening (mm) using a digital caliper.

Time frame
Postoperative Days 1, 2, 3, and 7

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Final International University

Lead sponsor

Source ClinicalTrials.gov
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