Trial intelligence / Profile preview

Peri-Operative Glucocorticoid Use in Odontogenic Infections

NCT05951504Phase 3

Key facts

Status
Completed
Start
Jun 2022
Primary completion
Mar 2023
Countries
1
Sponsor
University of Manitoba
Modality
Orthosteric Ligands
Conditions
odontogenic infection (OI)
01

Overview

Phase 3, randomised, open-label trial of methylprednisolone injection in odontogenic infection (OI) (2 arms), sponsored by University of Manitoba. Primary endpoints: Length of Hospital Admission, White Blood Cell Count and 3 more. Started Jun 2022; status: completed.

02

Design

2 arms
Study design
RandomizedOpen-label
  • Solumedrol 1 Dose

    1 dose of Solumedrol 125mg IV at surgery

  • Solumedrol 4 Dose

    1 dose of Solumedrol 125mg IV at surgery + 3 doses q6h

03

Who it enrols

Adult patients with cervicofacial infection of odontogenic origin requiring hospital admission and surgery. Excludes patients with contraindications to steroids (e.g., uncontrolled diabetes, renal disease, psychosis, pregnancy) or non-odontogenic infections.

04

Endpoints

Primary

  • Length of Hospital Admission

  • White Blood Cell Count

  • C-Reactive Protein Level

  • Improvement in Mouth Opening

  • Daily clinical examination findings

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