Facial Swelling, Tooth Avulsion, Tooth Extraction Status Nos, Tooth, Impacted, Tooth Position Anomalies
Conditions
Keywords
third molar surgery, facial swelling, 3D facial swelling evaluation, tooth impacted, prednisone drug administration, corticosteroids administration
Brief summary
The present study proposes to compare the effect of a single preoperative dose of prednisone versus placebo in terms of facial swelling, trismus and pain after surgical removal of the mandibular third molar (M3M) in a split-mouth randomized controlled clinical trial.
Detailed description
This study aims to compare the effect of a single preoperative dose of prednisone versus placebo in terms of facial swelling, trismus, and pain after surgical removal of M3M in a split-mouth randomized controlled clinical trial. Facial swelling will be evaluated using an innovative three-dimensional digital technique.
Interventions
DRUGPrednisone
Pre-operative drug administration before third molar surgery
DRUGPlacebo
Pre-operative Placebo administration before third molar surgery
Sponsors
University Magna Graecia
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
* 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 * History of systemic corticosteroid therapy in the past 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in facial swelling | Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery | To compare the effectiveness of prednisone/os versus placebo in reducing facial swelling using qualitative three-dimensional analysis (measured by colorimetric variation given by the overlapping volumes) . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in trismus | Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery | To assess the effects of prednisone/os administration on trismus (measured in cm) |
| Change in pain 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 prednisone/os administration on pain (measured by VAS-score from 0 to 10 point, with 10 as the worst outcome) |
Countries
Italy
Outcome results
None listed