Clinical Trial Results:
Effect of systemic antibiotic therapy on postoperative complications in patients undergoing wisdom teeth removal surgery. A double-blind, randomised, placebo-controlled Trial
Summary
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EudraCT number |
2017-004986-28 |
Trial protocol |
AT |
Global end of trial date |
06 Sep 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
18 Aug 2024
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First version publication date |
18 Aug 2024
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Other versions |
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Summary report(s) |
Clinical Oral Investigations (2022) 26:6409–6421 |
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 |
AMOXI
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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 |
Medical University of Graz
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Sponsor organisation address |
Neue Stiftingtalstrasse 6, Graz, Austria, 8010
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Public contact |
Principal Investigator , Prof PD DDr. Michael Payer, 0043 316385 80659, mi.payer@medunigraz.at
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Scientific contact |
Principal Investigator , Prof PD DDr. Michael Payer, 1638578049 316385 80659, mi.payer@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 |
02 Feb 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
02 Feb 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
06 Sep 2022
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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 evaluate whether the perioperative usage of antibiotics is effective in reducing postoperative complications, compared to placebo, in patients undergoing wisdom teeth removal.
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Protection of trial subjects |
standard of care study
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
30 Jan 2019
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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: 59
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Worldwide total number of subjects |
59
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EEA total number of subjects |
59
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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) |
10
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Adults (18-64 years) |
49
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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 |
- | |||||||||||||||
Pre-assignment
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Screening details |
Patients aged 16 years or older who were referred for surgical removal of four impacted or slightly impacted wisdom teeth between May 2019 and July 2021 were considered participants in this study. | |||||||||||||||
Period 1
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Period 1 title |
RCT (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 |
Subject, Investigator | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Amoxicillin | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Amoxicillin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
An hour before the start of wisdom tooth removal on the day of the first and second surgery, all patients received 40 mg of methylprednisolone orally and their study medication (26 hard gelatin capsules in a resealable container). The study medication was prepared at the local hospital pharmacy using Amoxilan 1000-mg tablets, newly packaged into hard gelatin capsules containing 250 mg amoxicillin each. Eight capsules were taken immediately, and on the following 3 days, six capsules (3 × 2 every 8 h).
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Arm title
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Placebo | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
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 |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
An hour before the start of wisdom tooth removal on the day of the first and second surgery, all patients received 40 mg of methylprednisolone orally and their study medication (26 hard gelatin capsules in a resealable container). The study medication was prepared at the local hospital pharmacy using Amoxilan 1000-mg tablets, newly packaged into hard gelatin capsules containing 250 mg amoxicillin each. Eight capsules were taken immediately, and on the following 3 days, six capsules (3 × 2 every 8 h).
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End points reporting groups
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Reporting group title |
Amoxicillin
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Reporting group description |
- | ||
Reporting group title |
Placebo
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Reporting group description |
- |
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End point title |
Surgical site infections (SSI) | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
day 1 and day 7 post surgery
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Statistical analysis title |
Fisher’s exact test | |||||||||
Statistical analysis description |
For the
primary outcome variable, Fisher’s exact test was performed
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Comparison groups |
Amoxicillin v Placebo
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Number of subjects included in analysis |
49
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | |||||||||
P-value |
< 0.05 | |||||||||
Method |
Fisher exact | |||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
25-Mar-2019 until 24-Mar-2022
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Assessment type |
Systematic | ||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||
Dictionary version |
25.0
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Reporting groups
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Reporting group title |
adverse events
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Reporting group description |
- | ||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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28 Feb 2019 |
Version 4.0, dated 28-Feb-2019 |
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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 |