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NCT Number: NCT05830747

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

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.

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Key information

Conditions

Facial Swelling Stomatognathic Diseases Tooth Avulsion Tooth Diseases Tooth Extraction Status Nos Tooth Injuries Tooth Position Anomalies Tooth, Impacted Wounds and Injuries

Age range

18 year–32 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Magna Graecia University of Catanzaro

Catanzaro, CZ, 88100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prednisone

Drug

Pre-operative drug administration before third molar surgery

Placebo

Drug

Pre-operative Placebo administration before third molar surgery

Primary outcomes

  1. Change in facial swelling

    Time frame: 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 qualitative three-dimensional analysis (measured by colorimetric variation given by the overlapping volumes) .

  2. Change in facial swelling

    Time frame: 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 outcomes

  1. Change in trismus

    Time frame: 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)

  2. Change in pain with Visual analogue scale (VAS)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University Magna Graecia

Other

Registry information

Official study title

Three-dimensional Facial Swelling Evaluation of Pre-operative Single-dose of Prednisone in Third Molar Surgery: a Split-mouth Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 26, 2023
Registry last updated
Apr 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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