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

U

University Magna Graecia

Status and phase

Completed
Phase 4

Conditions

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

Treatments

Drug: Prednisone
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05830747
465/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment

34 patients

Sex

All

Ages

18 to 32 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

34 participants in 2 patient groups, including a placebo group

Prednisone group (PG)
Experimental group
Description:
Patients receiving a preoperative administration of prednisone 25 mg/os.
Treatment:
Drug: Prednisone
Control group (CG)
Placebo Comparator group
Description:
Patients receiving a preoperative administration of Placebo.
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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