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
Brief summary
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
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.
Interventions
BIOLOGICALPRF
Post-operative PRF placement in the post-extraction socket after third molar surgery
Sponsors
Amerigo Giudice
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 32 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Facial swelling qualitative analysis | Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery | To compare the effectiveness of PRF in reducing facial swelling using qualitative three-dimensional analysis (measured by colorimetric variation given by the overlapping volumes) . |
| Facial swelling quantitative analysis - volumetric differences | Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery | To compare the effectiveness of PRF in reducing facial swelling using quantitative three-dimensional analysis ( volumes measured in cm3) . |
| Facial swelling quantitative analysis - linear differences | Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery | To compare the effectiveness of PRF in reducing facial swelling using quantitative three-dimensional analysis (linear differences measured in cm2) . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Trismus analysis | Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery | To assess the effects of PRF administration on trismus (measured in cm) |
| Pain analysis with Visual analogue scale (VAS) | Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery | To assess the effects of PRF administration on pain (measured by VAS-score from 0 to 10 point, with 10 as the worst outcome) |
Countries
Italy
Outcome results
None listed