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

Phase 4

Completed

• Conditions: Facial Swelling; Tooth Position Anomalies; Tooth, Impacted; Tooth Extraction Status Nos; Tooth Avulsion
• Interventions: Drug: Prednisone; Drug: Placebo

• Registration Number: NCT05830747
• Lead Sponsor: University Magna Graecia

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.

Study Timeline

• Study Start: 2022-02-01
• Primary Completion: 2022-10-25
• Study Completion: 2022-12-10
• Study First Submitted: 2023-03-27
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-23
• Last Update Submitted: 2023-04-23
• Study First Posted: 2023-04-26
• Last Update Posted: 2023-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Prednisone group (PG)	Prednisone	Patients receiving a preoperative administration of prednisone 25 mg/os.
Control group (CG)	Placebo	Patients receiving a preoperative administration of Placebo.

Primary Outcome Measures

Name	Time	Method
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 quantitative three-dimensional analysis (differences are measured in cm3).

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Magna Graecia University of Catanzaro; 🇮🇹 Catanzaro, CZ, Italy