Facial Swelling, Tooth Avulsion, Tooth Extraction Status Nos, Tooth, Impacted, Tooth Position Anomalies
Conditions
Keywords
third molar surgery, facial swelling, 3D facial swelling evaluation, PRF, tooth impacted, platelet rich fibrin, antibiotic delivery
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.
Interventions
BIOLOGICALAntibiotic-enriched 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.
BIOLOGICALPlatelet-Rich Fibrin (PRF)
Standard platelet-rich fibrin prepared without antibiotic addition and applied into the mandibular third molar extraction socket.
Sponsors
Amerigo Giudice
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 32 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Facial swelling quantitative analysis - volumetric differences | 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 | 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. |
| Incidence of postoperative infection | 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 qualitative analysis | 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
| Measure | Time frame | Description |
|---|---|---|
| Trismus analysis | 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). |
| Pain analysis with Visual analogue scale (VAS) | 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). |
Countries
Italy
Outcome results
None listed