Comparison of PRF and Corticosteroids in Impacted Third Molar Surgery

NCT07742826 — Not applicable, Recruiting, 60 participants, Final International University

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

Registry	NCT07742826
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	60 (Estimated)
Sponsor	Final International University (Other)
Conditions	Impacted Mandibular Third Molar Extraction, Impacted Lower Third Molar, Impacted Wisdom Tooth
Interventions	Platelet-rich fibrin (PRF), Dexamethasone, Amoxicillin/Clavulanic Acid, Paracetamol, Chlorhexidine (Biological, drug)
Dates	start 2024-09-03, primary completion 2026-08-01 (estimated), completion 2026-08-01 (estimated), first posted 2026-08-03, last updated 2026-08-03
Locations	1 site in Cyprus

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Standard Postoperative Treatment (Control)	Active comparator	Drug: Amoxicillin/Clavulanic Acid; Drug: Paracetamol; Drug: Chlorhexidine	Participants receive standard postoperative treatment following impacted mandibular third molar surgery, including amoxicillin/clavulanic acid (Augmentin), paracetamol, and chlorhexidine mouthwash. No platelet-rich fibrin (PRF) or corticosteroid is administered.
Platelet-Rich Fibrin (PRF)	Experimental	Biological: Platelet-rich fibrin (PRF); Drug: Amoxicillin/Clavulanic Acid; Drug: Paracetamol; Drug: Chlorhexidine	Participants receive platelet-rich fibrin (PRF) placed into the extraction socket in addition to standard postoperative treatment consisting of amoxicillin/clavulanic acid (Augmentin), paracetamol, and chlorhexidine mouthwash following impacted mandibular third molar surgery.
Platelet-Rich Fibrin Plus Corticosteroid	Experimental	Biological: Platelet-rich fibrin (PRF); Drug: Dexamethasone; Drug: Amoxicillin/Clavulanic Acid; Drug: Paracetamol; Drug: Chlorhexidine	Participants receive platelet-rich fibrin (PRF) placement into the extraction socket followed by intramuscular corticosteroid administration, in addition to standard postoperative treatment consisting of amoxicillin/clavulanic acid (Augmentin), paracetamol, and chlorhexidine mouthwash following impacted mandibular third molar surgery.

Platelet-rich fibrin (PRF) (Biological): 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.

+Outcome measures

Primary outcomes

Postoperative Pain [Postoperative Days 1, 2, 3, and 7]: Postoperative pain assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable.
Postoperative Swelling [Postoperative Days 1, 2, 3, and 7]: 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.
Trismus [Postoperative Days 1, 2, 3, and 7]: Trismus assessed by measuring the maximum interincisal mouth opening (mm) using a digital caliper.

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Final International University Faculty of Dentistry	Nicosia	Cyprus	Recruiting

+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