CompletedPhase 4

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

Italy34 participantsStarted 2022-02-01

Plain-language 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.

Who can participate

Age range

18 Years – 32 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in facial swelling

Timeframe: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery

Change in facial swelling

Timeframe: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery

Trial details

NCT IDNCT05830747

SponsorUniversity Magna Graecia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-25

View on ClinicalTrials.gov More Facial Swelling trials

Who can participate

Age range

18 Years – 32 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.