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

N/AActive Not RecruitingNCT07764757

Amerigo Giudice31 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Facial Swelling Tooth Position Anomalies Tooth, Impacted Tooth Extraction Status Nos Tooth Avulsion

Interventions

Antibiotic-enriched Platelet-Rich Fibrin (PRF)BIOLOGICAL

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)BIOLOGICAL

Standard platelet-rich fibrin prepared without antibiotic addition and applied into the mandibular third molar extraction socket.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 32 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Magna Graecia University of Catanzaro

Catanzaro, cz, Italy

Outcomes

Primary Outcomes

Incidence of postoperative infection

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).

Time frame: Up to 7 days after surgery

Facial swelling qualitative analysis

Change in facial volume from baseline, assessed by three-dimensional facial scan superimposition and expressed as colorimetric variation between the preoperative and postoperative scans.

Time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery

Facial swelling quantitative analysis - volumetric differences

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.

Time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery

Facial swelling quantitative analysis - linear differences

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.

Time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery

Secondary Outcomes

Trismus analysis

To compare postoperative limitation of mouth opening between treatment groups following mandibular third molar surgery. Trismus will be assessed by measuring maximum mouth opening (MMO) in millimeters (mm).

Data from ClinicalTrials.gov

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