Effect of Pre-emptive Dose of Prednisone Versus Placebo in Impacted Third Molar Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Three-dimensional Facial Swelling Evaluation of Pre-operative Single-dose of Prednisone in Third Molar Surgery: a Split-mouth Randomized Controlled 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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* Drug: Prednisone
* Drug: Placebo


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 History of systemic corticosteroid therapy in the past 4 weeks

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: Prednisone group (PG)<br>Patients receiving a preoperative administration of prednisone 25 mg/os. | Drug: Prednisone<br>* Pre-operative drug administration before third molar surgery<br>|
| Placebo Comparator: Control group (CG)<br>Patients receiving a preoperative administration of Placebo. | Drug: Placebo<br>* Pre-operative Placebo administration before third molar surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in facial swelling | 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) . | Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery | 
| Change in facial swelling | To compare the effectiveness of prednisone/os versus placebo in reducing facial swelling using quantitative three-dimensional analysis (differences are measured in cm3). | 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 |
| --- | --- | --- |
| Change in trismus | To assess the effects of prednisone/os administration on trismus (measured in cm) | Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery | 
| Change in pain with Visual analogue scale (VAS) | 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) | 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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third molar surgery, facial swelling, 3D facial swelling evaluation, tooth impacted, prednisone drug administration, corticosteroids administration