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

Sponsor

University Magna Graecia (Other)

Overall Status

Completed

CT.gov ID

NCT05830747

Collaborator

(none)

Enrollment

Location

Arms

10.3

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Facial Swelling Tooth Position Anomalies Tooth, Impacted Tooth Extraction Status Nos Tooth Avulsion	Drug: Prednisone Drug: Placebo	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2022

Actual Primary Completion Date :

Oct 25, 2022

Actual Study Completion Date :

Dec 10, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 32 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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