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

NCT07764757 | Active Not Recruiting

• 1 other identifier: 23/2023
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

third molar surgery; facial swelling; 3D facial swelling evaluation; PRF; tooth impacted; platelet rich fibrin; antibiotic delivery

Outcome Measures

Primary Outcomes (4)

• 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).

  Up to 7 days after surgery

• Facial swelling qualitative analysis

  Comparison of postoperative facial swelling between treatment groups using a qualitative three-dimensional analysis based on superimposition of facial scans and colorimetric variation assessment.

  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.

  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.

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

Secondary Outcomes (2)

• Trismus analysis

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

• Pain analysis with Visual analogue scale (VAS)

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

Study Arms (2)

Test Group

EXPERIMENTAL

Participants will receive platelet-rich fibrin prepared with the addition of antibiotic prior to centrifugation. The antibiotic-enriched PRF clot will be placed into the mandibular third molar extraction socket to provide local antibiotic delivery at the surgical site.

Biological: Antibiotic-enriched Platelet-Rich Fibrin (PRF)

Control Group

ACTIVE COMPARATOR

Participants will receive standard platelet-rich fibrin prepared without antibiotic addition. The PRF clot will be placed into the mandibular third molar extraction socket according to the same surgical protocol.

Biological: Platelet-Rich Fibrin (PRF)

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.

Test Group

Platelet-Rich Fibrin (PRF) BIOLOGICAL

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

Control Group

Eligibility Criteria

• Age: 18 Years - 32 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amerigo Giudice: lead

Study Sites (1)

Magna Graecia University of Catanzaro

Catanzaro, cz, 88100, Italy

Location

MeSH Terms

Conditions

Tooth, Impacted; Tooth Avulsion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Tooth Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 14, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 20, 2026
• Last Updated: August 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)