Einfluss von peroraler Methylprednisolon-Gabe auf die postoperative Morbidität nach operativer Weisheitszahnenfernung im Unterkiefer.(Influence of peroral Methylprednisolone administration on the postsurgical morbidity after surgical removal of lower third molars.)

Phase 1

• Conditions: To be investigated is the anti-inflammatory and anti-oedematous effect of methylprednisolone on the postoperative sequelae after surgical removal of lower third molars.16 healthy patients will undergo surgical removal of bilateral symmetrically placed lower third molars. Each patient will be administered 1mg methylprednisolone per kg weight 1 hour prior to the surgery on one side, and a placebo containing lactose an the other side on a random basis.

• Registration Number: EUCTR2007-006252-19-AT
• Lead Sponsor: niv.-Prof. DDr. Norbert Jakse, Universitätszahnklinik Graz, Dep. f. Orale Chirurgie u. Röntgenologi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-08
• Last Update Posted: 7 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

+male and female healthy patients between the age of 18 and 40
+lower third molars which have to be removed surgically
+impacted lower third molars
+axis: vertical or mesial tilted
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-preagnancy and lactation
-patients with an affection of the Temporo-mandibular joint
-presurgical inflammation or pain in the area of the lower third molars
-diseases which are a contraindication for the use of one of the drugs to be taken
-incompatibility to one of the drugs to be taken or lactose
-severe diseases which are a contraindication to a surgical removal of third molars
-current participation in other pharmacological studies
-when a complicated removal of the lower third molar can be anticipated because of its position in the jaw

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified