An interventional study of Antibiotic-enriched Platelet-Rich Fibrin (PRF) and Platelet-Rich Fibrin (PRF) in Facial Swelling, Tooth Position Anomalies and Tooth, Impacted, sponsored by Amerigo Giudice. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years to 32 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Amerigo Giudice · Not applicable, Interventional, and Treatment
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.
122 studies on the registry are indexed under Tooth, Impacted; 15 are open to participants now.
This study's enrollment of 31 is below the median of 70 across 88 interventional studies indexed under Tooth, Impacted.
Browse Tooth, Impacted studies →Amerigo Giudice is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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.
Standard platelet-rich fibrin prepared without antibiotic addition and applied into the mandibular third molar extraction socket.
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
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).
Time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Pain analysis with Visual analogue scale (VAS)
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).
Time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Plan to share: No
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This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: P-prf
Amerigo Giudice