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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.)

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.)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-006252-19-AT
Enrollment
16
Registered
2008-07-08
Start date
2008-07-24
Completion date
Unknown
Last updated
2016-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Product Name: Methylprednisolon Product Code: MP Pharmaceutical Form: Capsule, hard Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use

Sponsors

Univ.-Prof. DDr. Norbert Jakse, Universitätszahnklinik Graz, Dep. f. Orale Chirurgie u. Röntgenologi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Main Objective: To find out if methylprednisolone reduces the postsurgical trismus, pain and swelling of the cheek after surgical removal of lower third molars.;Secondary Objective: ;Primary end point(s):

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026