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

University Magna Graecia34 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

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

Interventions

PrednisoneDRUG

Pre-operative drug administration before third molar surgery

PlaceboDRUG

Pre-operative Placebo administration before third molar surgery

Eligibility

Sex: ALLMin age: 18 YearsMax age: 32 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Magna Graecia University of Catanzaro

Catanzaro, CZ, Italy

Outcomes

Primary Outcomes

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) .

Time frame: 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).

Time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery

Secondary Outcomes

Change in trismus

To assess the effects of prednisone/os administration on trismus (measured in cm)

Time frame: 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)

Time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery

Data from ClinicalTrials.gov

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