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

April 23, 2023 updated by: Amerigo Giudice, University Magna Graecia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • CZ
      • Catanzaro, CZ, Italy, 88100
        • Magna Graecia University of Catanzaro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prednisone group (PG)
Patients receiving a preoperative administration of prednisone 25 mg/os.
Drug: Prednisone
Pre-operative drug administration before third molar surgery
Placebo Comparator: Control group (CG)
Patients receiving a preoperative administration of Placebo.
Drug: Placebo
Pre-operative Placebo administration before third molar surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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) .
Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
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).
Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
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)
Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Magna Graecia

Investigators

  • Principal Investigator: Alessandro Antonelli, PhDs, DDS, Magna Graecia University of Catanzaro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Actual)

October 25, 2022

Study Completion (Actual)

December 10, 2022

Study Registration Dates

First Submitted

March 27, 2023

First Submitted That Met QC Criteria

April 23, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 23, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 465/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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