Platelet-Rich Fibrin as an Antibiotic Delivery Vehicle in Mandibular Third Molar Surgery
18 augusti 2026 uppdaterad av: Amerigo Giudice
Effects of Antibiotic-Prepared Platelet-Rich Fibrin on Postoperative Recovery After Mandibular Third Molar Surgery: A Randomized Split-Mouth Clinical Trial
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.
Studieöversikt
Status
Aktiv, inte rekryterande
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
31
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
cz
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Catanzaro, cz, Italien, 88100
- Magna Graecia University of Catanzaro
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Ja
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
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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.
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Aktiv komparator: 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.
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Standard platelet-rich fibrin prepared without antibiotic addition and applied into the mandibular third molar extraction socket.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Incidence of postoperative infection
Tidsram: Up to 7 days after surgery
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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).
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Up to 7 days after surgery
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Facial swelling quantitative analysis - volumetric differences
Tidsram: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
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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.
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Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
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Facial swelling quantitative analysis - linear differences
Tidsram: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
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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.
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Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
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Facial swelling qualitative analysis
Tidsram: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
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Change in facial volume from baseline, assessed by three-dimensional facial scan superimposition and expressed as colorimetric variation between the preoperative and postoperative scans.
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Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Trismus analysis
Tidsram: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
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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).
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Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
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Pain analysis with Visual analogue scale (VAS)
Tidsram: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
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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).
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Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 november 2025
Primärt slutförande (Beräknad)
1 september 2026
Avslutad studie (Beräknad)
20 november 2026
Studieregistreringsdatum
Först inskickad
10 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
10 augusti 2026
Första postat (Faktisk)
14 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 augusti 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 23/2023
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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