Platelet-Rich Fibrin as an Antibiotic Delivery Vehicle in Mandibular Third Molar Surgery (NCT07764757) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Platelet-Rich Fibrin as an Antibiotic Delivery Vehicle in Mandibular Third Molar Surgery
Italy31 participantsStarted 2025-11-01
Plain-language 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.
Who can participate
Age range
18 Years – 32 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of postoperative infection
Timeframe: Up to 7 days after surgery
2
Facial swelling qualitative analysis
Timeframe: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery