The Use of Platelet-rich-fibrin in Lower Third Molar Surgery.

Study Overview
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Brief Summary
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The present study aims to analyze the effect of PRF (Platelet-rich-fibrin) in terms of facial swelling, trismus and pain after surgical removal of mandibular third molar (M3M) in a split-mouth randomized controlled clinical trial.

Detailed Description
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The present study aims to analyze the effect of PRF (Platelet-rich-fibrin) in terms of facial swelling, trismus and pain after surgical removal of mandibular third molar (M3M) in a split-mouth randomized controlled clinical trial. Facial swelling will be assessed using an innovative three-dimensional digital technique.

Official Title
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The Use of Platelet-rich-fibrin in Lower Third Molar Surgery: a Split-mouth Randomized Clinical Trial

Conditions
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Facial Swelling, Tooth Position Anomalies, Tooth, Impacted, Tooth Extraction Status Nos, Tooth Avulsion

Intervention / Treatment
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* Biological: PRF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 to 32 years who required both M3M extractions were recruited Good health status Indication to surgical extraction of both M3M Complete root formation Surgical risk level classified as Conventional or Moderate according to Daugela et al. classification Exclusion Criteria: Person under the age of 18 or over 32 Allergy or contraindications to administration of corticosteroids Acute infection in any of the teeth to be extracted Patients with chronic liver disease, diabetes, immune system dysfunction, or haematological disease Pregnancy or breastfeeding History of treatment with antiresorptive drugs Chronic kidney disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 32 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Group<br>Placement of PRF in the post-extraction socket after third molar surgery | Biological: PRF<br>* Post-operative PRF placement in the post-extraction socket after third molar surgery<br>|
| No Intervention: Control Group<br>No positioning PRF in the post-extraction socket after third molar surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial swelling qualitative analysis | To compare the effectiveness of PRF in reducing facial swelling using qualitative three-dimensional analysis (measured by colorimetric variation given by the overlapping volumes) . | Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery | 
| Facial swelling quantitative analysis - volumetric differences | To compare the effectiveness of PRF in reducing facial swelling using quantitative three-dimensional analysis ( volumes measured in cm3) . | Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery | 
| Facial swelling quantitative analysis - linear differences | To compare the effectiveness of PRF in reducing facial swelling using quantitative three-dimensional analysis (linear differences measured in cm2) . | Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trismus analysis | To assess the effects of PRF administration on trismus (measured in cm) | Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery | 
| Pain analysis with Visual analogue scale (VAS) | To assess the effects of PRF administration on pain (measured by VAS-score from 0 to 10 point, with 10 as the worst outcome) | Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PRF, third molar surgery, facial swelling, 3D facial swelling evaluation, tooth impacted, platelet rich fibrin