Impacted Mandibular Third Molar Extraction, Impacted Lower Third Molar, Impacted Wisdom Tooth
Conditions
Keywords
Third Molar Surgery, Impacted Third Molar, Platelet-Rich Fibrin, Corticosteroids, Postoperative Pain, Facial Swelling, Trismus, Oral Surgery, Postoperative Complications
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.
Interventions
BIOLOGICALPlatelet-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.
DRUGDexamethasone
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 administered postoperatively according to the study protocol.
DRUGParacetamol
Paracetamol 500 mg tablets administered postoperatively for pain control according to the study protocol.
DRUGChlorhexidine
Chlorhexidine mouthwash administered postoperatively according to the study protocol.
Sponsors
Final International University
Study design
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.
Intervention model description
Participants are randomly assigned by a simple randomization method (dice roll) to one of three parallel groups: a control group receiving standard treatment, a platelet-rich fibrin (PRF) group, or a PRF combined with corticosteroid group. Each participant receives only the intervention assigned at enrollment, and postoperative outcomes are compared between the groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Cyprus
Contacts
CONTACTMeliz Kneebone, DDS
Outcome results
None listed