Ireland
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Active, not recruiting Not applicable

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

NCT07764757 · tracked via the Priya Life Science Italy tracker
Sponsor
Amerigo Giudice
Phase
Not applicable
Started
2025-11-01
Last updated
2026-08-20

Condition(s) studied

Facial SwellingTooth Position AnomaliesTooth, ImpactedTooth Extraction Status NosTooth Avulsion

Investigational drug(s) / intervention(s)

Antibiotic-enriched Platelet-Rich Fibrin (PRF)Platelet-Rich Fibrin (PRF) →

Antibiotic-enriched Platelet-Rich Fibrin (PRF): Platelet-rich fibrin prepared with the addition of antibiotic prior to centrifugation and applied into the mandibular third molar extraction socket to provide local antibiotic delivery.

Platelet-Rich Fibrin (PRF): Standard platelet-rich fibrin prepared without antibiotic addition and applied into the mandibular third molar extraction socket.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
32 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Healthy patients (ASA I) according to the American Society of Anesthesiologists classification. * Age 18-32 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: * 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 outcome measure(s)

  • Incidence of postoperative infection — Up to 7 days after surgery
    Occurrence of postoperative infection following mandibular third molar surgery, assessed through clinical examination based on the presence of signs and symptoms of infection (e.g., purulent discharge, erythema, fever, or need for additional antibiotic therapy).
  • Facial swelling qualitative analysis — Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
    Change in facial volume from baseline, assessed by three-dimensional facial scan superimposition and expressed as colorimetric variation between the preoperative and postoperative scans.
  • Facial swelling quantitative analysis - volumetric differences — Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
    To compare postoperative facial swelling between treatment groups using quantitative three-dimensional analysis based on volumetric differences. Facial volume changes will be measured in cubic centimeters (cm³) through three-dimensional facial scan superimposition.
  • Facial swelling quantitative analysis - linear differences — Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
    To compare postoperative facial swelling between treatment groups using quantitative three-dimensional analysis based on linear measurements. Facial changes will be assessed by evaluating linear differences (mm) between preoperative and postoperative three-dimensional facial scans.

Trial sites (1)

FacilityCityRegionStatus
Magna Graecia University of Catanzaro Catanzaro cz
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07764757 on ClinicalTrials.gov ↗ ← All trials in Italy