Effects of Antibiotic-Prepared Platelet-Rich Fibrin on Postoperative Recovery After Mandibular Third Molar Surgery: A Randomized Split-Mouth Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Incidence of postoperative infection
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes assessor)
Eligibility Criteria
- Ages
- 18 Years to 32 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Test Group - Antibiotic and PRF
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.
Intervention: Antibiotic-enriched Platelet-Rich Fibrin (PRF) (Biological)
Control Group - PRF only
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.
Intervention: Platelet-Rich Fibrin (PRF) (Biological)
Outcomes
Primary Outcomes
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).
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.
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.
Facial swelling qualitative analysis
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Amerigo Giudice
Professor
University Magna Graecia
Study Sites (1)
Identifiers
- NCT ID
- NCT07764757
- Other Study IDs
- 23/2023
Dates
- First Submitted
- (last month)
- First Posted
- (last month)
- Primary Completion
- (29 days ago)
- Study Completion
- (next month)
- Last Verified
- (3 months ago)
- Last updated
- (last month)
Regulatory & Sharing
- FDA Regulated Drug
- No
- FDA Regulated Device
- No
- IPD Sharing Plan
- No
- Has Results
- No