CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 154 enrolled
Drug / intervention
methylprednisolone +3 moredrug
Likely dose
methylprednisolone 32 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00805298
NCT00805298N/ACompleted

Assessment of the Operative Course in Connection With Removal of Lower Third Molars With Particular Consideration to the Occurence of Pain and Swelling

University of Aarhus·interventional·Posted Dec 9, 2008·Updated Oct 24, 2012

In Brief

A clinical study evaluating methylprednisolone, placebo, and 2 other interventions for Postoperative Pain and Inflammation. Completed, enrolled 154 participants across 1 site.

Detailed Summary

The aim of this study is to compare postoperative complications after removal of lower third molars using two different types of anaesthetics and two different treatments against swelling and inflammation (methylprednisolone and placebo). The hypothesis is that a combination of a long-duration anaesthetic combined methylprednisolone will result in significantly less postoperative pain and inflammation. Patients will have both lower third molars removed on two separate occasions. Each patient is randomly assigned to receive one type of local anaesthetic the first time and the other type the second time. Furthermore patients are randomised to receive either methylprednisolone or placebo the first time and the opposite treatment the second time. During the week after surgery patients fill out a questionnaire with questions about level of pain and swelling at different times as well as the patients' perception of other postoperative complications. The patient is examined by a dentist on the 2nd and 7th day after surgery, where postoperative complications are recorded and thermographic images of the patient's face are taken to assess the degree of inflammation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark

Timeline

N/ACompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 9, 2008
Enrollment StartAug 1, 2008
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 17.6 years ago

Interventions

methylprednisolonedrug

32 mg before surgery, 16 mg twice daily the day after surgery

placebodrug

two tablets before surgery, one tablet twice daily on the day after surgery

xyloplyin adrenalindrug

lidocaine local anaesthetic lidocaine 20 mg/ml, adrenalin 12,5 µg/ml maximum dosage 10 ml.

marcain adrenalindrug

bupivacaine local anaesthetic bupivacaine 5 mg /ml, adrenaline 5 µg/ml maximum dosage 10 ml