Platelet-Rich Fibrin as an Antibiotic Delivery Vehicle in Mandibular Third Molar Surgery

Effects of Antibiotic-Prepared Platelet-Rich Fibrin on Postoperative Recovery After Mandibular Third Molar Surgery: A Randomized Split-Mouth Clinical Trial

Registry ID
NCT07764757
Source registry
NCT
Status
ACTIVE_NOT_RECRUITING
Phase
NA
Study type
INTERVENTIONAL
Sponsor
Amerigo Giudice
Enrollment
31
Start date
2025-11-01
Completion date
2026-11-20
Last update
2026-08-14

Conditions

Summary

The present study aims to evaluate the effect of platelet-rich fibrin (PRF) used as a local antibiotic delivery vehicle on postoperative outcomes, including facial swelling, trismus, and pain, following mandibular third molar surgery in a randomized split-mouth clinical trial.

Interventions

Inclusion criteria

Inclusion Criteria: * Healthy patients (ASA I) according to the American Society of Anesthesiologists classification. * Age 18-34 years. * Ability to provide written informed consent. * Bilateral mandibular third molars requiring extraction for prophylactic, therapeutic, or strategic reasons. * Complete root development of mandibular third molars (Shumaker Stage H). * Availability of diagnostic-quality CBCT scans with adequate field of view (17 × 20). * Mandibular third molars classified as having conventional or moderate surgical difficulty according to Juodzbalys and Daugela classification.

Exclusion criteria

Exclusion Criteria: * Known allergy to corticosteroids. * Immunosuppression or immunocompromised conditions. * Acute infection at the mandibular third molar extraction sites. * Current or previous intravenous amino-bisphosphonate therapy. * Psychiatric disorders. * Thrombocytopenia (platelet count \<40,000/µL), thrombocytosis, or other coagulation disorders. * Severe hepatic cirrhosis, advanced chronic renal failure, or uncontrolled -diabetes mellitus. * Pregnancy or breastfeeding. * Requirement for additional regenerative procedures (e.g., bone grafting). * Localized facial malformations involving the cheek region.

Primary outcomes

[{"measure":"Incidence of postoperative infection","timeFrame":"Up to 7 days after surgery"},{"measure":"Facial swelling qualitative analysis","timeFrame":"Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery"},{"measure":"Facial swelling quantitative analysis - volumetric differences","timeFrame":"Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery"},{"measure":"Facial swelling quantitative analysis - linear differences","timeFrame":"Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery"}]

Locations

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