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NCT Number: NCT07764757

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Facial Swelling Stomatognathic Diseases Tooth Avulsion Tooth Diseases Tooth Extraction Status Nos Tooth Injuries Tooth Position Anomalies Tooth, Impacted Wounds and Injuries

Age range

18 year–32 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Magna Graecia University of Catanzaro

Catanzaro, cz, 88100, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Incidence of postoperative infection

    Time frame: 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).

  2. Facial swelling qualitative analysis

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

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

  3. Facial swelling quantitative analysis - volumetric differences

    Time frame: 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.

  4. Facial swelling quantitative analysis - linear differences

    Time frame: 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.

Secondary outcomes

  1. Trismus analysis

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

    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).

  2. Pain analysis with Visual analogue scale (VAS)

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

    To compare postoperative pain intensity between treatment groups following mandibular third molar surgery. Pain will be assessed using a Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain).

Sponsors and collaborators

Lead sponsor

Amerigo Giudice

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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