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
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EudraCT number |
2007-006252-19 |
Trial protocol |
AT |
Global end of trial date |
23 Oct 2010
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Results information
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Results version number |
v1(current) |
This version publication date |
09 Dec 2020
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First version publication date |
09 Dec 2020
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
1.0.
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Department of Oral Surgery and Radiology,
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Sponsor organisation address |
Billrothgasse 4, Graz, Austria, 8010
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Public contact |
Clinical trials information, Department of Oral Surgery and Radiology,, norbert.jakse@medunigraz.at
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Scientific contact |
Clinical trials information, Department of Oral Surgery and Radiology,, norbert.jakse@medunigraz.at
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
30 Oct 2010
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
23 Oct 2010
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Global end of trial reached? |
Yes
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Global end of trial date |
23 Oct 2010
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Was the trial ended prematurely? |
No
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General information about the trial
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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.
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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
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
12 Nov 2008
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Austria: 16
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Worldwide total number of subjects |
16
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EEA total number of subjects |
16
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
16
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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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
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Screening details |
16 patients were enrolled, there were no screening failures | ||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||
Roles blinded |
Investigator, Subject | ||||||
Arms
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Arm title
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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
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Dosage was applied depending on the patients' body weight (40-80 mg).
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Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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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.
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Split-mouth: treatment and placebo
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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. |
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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).
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End point type |
Primary
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End point timeframe |
7 days postoperatively
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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. |
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Notes [2] - Since a split-mouth design was used all patients received both placebo and treatment. |
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
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End point timeframe |
7 days postoperatively
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
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End point timeframe |
7 days postoperatively
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
From informed consent to study completion
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||
Dictionary version |
23,1
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Reporting groups
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Reporting group title |
Split-mouth: treatment and placebo
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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. | ||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |