Comparison of Postoperative Effects of PRF and Corticosteroid Treatments in Impacted Third Molar Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Postoperative Pain
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Participants were randomly assigned to one of the three study groups by a dice roll. The operating surgeon was informed of the treatment allocation immediately before surgery to perform the assigned intervention. Postoperative outcome assessments were performed by a single independent examiner, who was different from the operating surgeon and remained the same examiner throughout the study. The outcome assessor was blinded to the treatment allocation.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Postoperative Pain
Time Frame: 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
Time Frame: 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
Time Frame: Postoperative Days 1, 2, 3, and 7
Trismus assessed by measuring the maximum interincisal mouth opening (mm) using a digital caliper.
Secondary Outcomes
No secondary outcomes reported
Investigators
Meliz Kneebone
Doctoral Researcher in Oral Surgery
Final International University