Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    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.)

    Summary
    EudraCT number
    		 2007-006252-19
    Trial protocol
    		 AT  
    Global end of trial date
    23 Oct 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Dec 2020
    First version publication date
    09 Dec 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    1.0.
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Department of Oral Surgery and Radiology,
    Sponsor organisation address
    Billrothgasse 4, Graz, Austria, 8010
    Public contact
    Clinical trials information, Department of Oral Surgery and Radiology,, norbert.jakse@medunigraz.at
    Scientific contact
    Clinical trials information, Department of Oral Surgery and Radiology,, norbert.jakse@medunigraz.at
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Oct 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Oct 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Oct 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To find out if methylprednisolone reduces the postsurgical trismus, pain and swelling of the cheek after surgical removal of lower third molars.
    Protection of trial subjects
    The study protocol and the informed consent form were approved by the Research and Ethics Committee of the Medical University Graz, Austria. The trial adhered to Good Clinical Practice guidelines, including the Declaration of Helsinki
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Nov 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    16
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Sixteen patients were recruited. The study was set up in a split-mouth design, so every patient received treatment and placebo.

    Pre-assignment
    Screening details
    		 16 patients were enrolled, there were no screening failures

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Arm title
    		 Split-mouth: treatment and placebo
    Arm description
    		 At random, each patient received weight-dependent methylprednisolone (40–80 mg) and a placebo orally 1 hour prior to surgery. Every patient received treatment and placebo due to the split mouth design.
    Arm type
    		 Experimental and placebo (split mouth)

    Investigational medicinal product name
    Methyprednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage was applied depending on the patients' body weight (40-80 mg).

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    At random, each patient received either weight-dependent methylprednisolone (40–80 mg) or a placebo orally 1 h prior to surgery. In each case, surgery was performed in independent visits.

    Number of subjects in period 1
    		Split-mouth: treatment and placebo
    Started
    16
    Completed
    16

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 16 16
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 16 16
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 6 6

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Split-mouth: treatment and placebo
    Reporting group description
    		 At random, each patient received weight-dependent methylprednisolone (40–80 mg) and a placebo orally 1 hour prior to surgery. Every patient received treatment and placebo due to the split mouth design.

    Primary: Trismus

    		 Close Top of page
    End point title
    		 Trismus [1]
    End point description
    Data analysis revealed a significant difference between the steroid group and placebo group on the first (P00.001) and third (P00.001) post-interventional days. The restriction of the mouth opening in the steroid group (day 1, 10.3 %; day 3, 5.4 %) was less than in the placebo group (day 1, 31.3 %; day 3, 20.4 %). On the seventh day after surgery, maximal inter-incisal opening approximated the preoperative situation in both groups (P00.462).
    End point type
    Primary
    End point timeframe
    7 days postoperatively
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis in presented in the end point description due to validation problems in the system, caused by the split-mouth design of the study (16 patients were included, but in total 32 interventions- placebo and treatment per patient - were administered). This caused validation issues in the statistical analysis section.
    End point values
    		 Split-mouth: treatment and placebo
    Number of subjects analysed
    16 [2]
    Units: millimeters
    16
    Notes
    [2] - Since a split-mouth design was used all patients received both placebo and treatment.
    No statistical analyses for this end point

    Secondary: Pain

    		 Close Top of page
    End point title
    		 Pain
    End point description
    Throughout the whole study period, VAS pain scores of the steroid group revealed a significant lower level (P00.001) than in the placebo group . The steroid group’s mean graph started and ended more than 10 mm lower than the placebo group’s graph on a 100 mm scale. Both scores decreased significantly over time.
    End point type
    Secondary
    End point timeframe
    7 days postoperatively
    End point values
    		 Split-mouth: treatment and placebo
    Number of subjects analysed
    16
    Units: Units on VAS score
    16
    No statistical analyses for this end point

    Secondary: Analgesic drug demand

    		 Close Top of page
    End point title
    		 Analgesic drug demand
    End point description
    For the whole study period, analgesic intake in the steroid group was significantly decreased compared with the placebo group . The mean of daily analgesic doses diminished in both groups significantly over time.
    End point type
    Secondary
    End point timeframe
    7 days postoperatively
    End point values
    		 Split-mouth: treatment and placebo
    Number of subjects analysed
    16
    Units: milligram
    16
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From informed consent to study completion
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23,1
    Reporting groups
    Reporting group title
    Split-mouth: treatment and placebo
    Reporting group description
    		 At random, each patient received weight-dependent methylprednisolone (40–80 mg) and a placebo orally 1 hour prior to surgery. Every patient received treatment and placebo due to the split mouth design.

    Serious adverse events
    		 Split-mouth: treatment and placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Split-mouth: treatment and placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 16 (100.00%)
    General disorders and administration site conditions
    Pain
    Additional description: Postoperative pain
         subjects affected / exposed
    15 / 16 (93.75%)
         occurrences all number
    31
    Swelling
         subjects affected / exposed
    16 / 16 (100.00%)
         occurrences all number
    27
    Musculoskeletal and connective tissue disorders
    Trismus
         subjects affected / exposed
    16 / 16 (100.00%)
         occurrences all number
    32

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu May 08 21:29:11 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA