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Recruiting NCT07742826

Comparison of PRF and Corticosteroids in Impacted Third Molar Surgery

No phase Interventional Impacted Mandibular Third Molar Extraction Impacted Lower Third Molar Impacted Wisdom Tooth

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Platelet-rich fibrin (PRF), Dexamethasone, Amoxicillin/Clavulanic Acid, Paracetamol.
Who it may be relevant to
Registry conditions: Impacted Mandibular Third Molar Extraction, Impacted Lower Third Molar, Impacted Wisdom Tooth. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Cyprus
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparison of Postoperative Effects of PRF and Corticosteroid Treatments in Impacted Third Molar Surgery

Overview

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.

Interventions

  • Biological Platelet-rich fibrin (PRF)
    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.
  • Drug Dexamethasone
    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.
  • Drug Amoxicillin/Clavulanic Acid
    Amoxicillin/clavulanic acid administered postoperatively according to the study protocol.
  • Drug Paracetamol
    Paracetamol 500 mg tablets administered postoperatively for pain control according to the study protocol.
  • Drug Chlorhexidine
    Chlorhexidine mouthwash administered postoperatively according to the study protocol.

Primary outcome measures

  • Postoperative Pain [Time frame: Postoperative Days 1, 2, 3, and 7]
  • Postoperative Swelling [Time frame: Postoperative Days 1, 2, 3, and 7]
  • Trismus [Time frame: Postoperative Days 1, 2, 3, and 7]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • Patients using corticosteroids, anticoagulants, immunosuppressive drugs, or bisphosphonates.
  • Patients with bleeding disorders.
  • Patients with previous radiotherapy to the head and neck region.
  • Patients unable or unwilling to comply with the study protocol or attend follow-up visits.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Cyprus · 1 center
  • Final International University Faculty of Dentistry — Nicosia

Publications

  • Donmezer CM, Bilginaylar K. Comparison of the Postoperative Effects of Local Antibiotic versus Systemic Antibiotic with the Use of Platelet-Rich Fibrin on Impacted Mandibular Third Molar Surgery: A Randomized Split-Mouth Study. Biomed Res Int. 2021 Dec 2;2021:3040661. doi: 10.1155/2021/3040661. eCollection 2021. PMID 34901267
  • Koc O, Er N, Karaca C, Bilginaylar K. Comparison of the effects of submucosal hyaluronidase and dexamethasone on postoperative edema, pain, trismus, and infection following impacted third molar surgery. BMC Oral Health. 2024 Aug 30;24(1):1018. doi: 10.1186/s12903-024-04729-1. PMID 39215323

Identifiers

NCT: NCT07742826 · Final International University

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗