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    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
    EudraCT number
    		 2017-004986-28
    Trial protocol
    		 AT  
    Global end of trial date
    06 Sep 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Aug 2024
    First version publication date
    18 Aug 2024
    Other versions
    Summary report(s)
    		 Clinical Oral Investigations (2022) 26:6409–6421

    Trial information

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    Trial identification
    Sponsor protocol code
    AMOXI
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Graz
    Sponsor organisation address
    Neue Stiftingtalstrasse 6, Graz, Austria, 8010
    Public contact
    Principal Investigator , Prof PD DDr. Michael Payer, 0043 316385 80659, mi.payer@medunigraz.at
    Scientific contact
    Principal Investigator , Prof PD DDr. Michael Payer, 1638578049 316385 80659, mi.payer@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
    02 Feb 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Feb 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Sep 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    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.
    Protection of trial subjects
    standard of care study
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jan 2019
    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: 59
    Worldwide total number of subjects
    59
    EEA total number of subjects
    59
    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)
    10
    Adults (18-64 years)
    49
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Amoxicillin
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Amoxicillin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    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).

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    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).

    Number of subjects in period 1
    		Amoxicillin Placebo
    Started
    30
    29
    Completed
    25
    25
    Not completed
    5
    4
         Consent withdrawn by subject
    5
    4

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Amoxicillin
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Surgical site infections (SSI)

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    End point title
    		 Surgical site infections (SSI)
    End point description
    End point type
    Primary
    End point timeframe
    day 1 and day 7 post surgery
    End point values
    		 Amoxicillin Placebo
    Number of subjects analysed
    25
    24
    Units: numbers
    25
    24
    Statistical analysis title
    		 Fisher’s exact test
    Statistical analysis description
    For the primary outcome variable, Fisher’s exact test was performed
    Comparison groups
    Amoxicillin v Placebo
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    25-Mar-2019 until 24-Mar-2022
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    adverse events
    Reporting group description
    		 -

    Serious adverse events
    		 adverse events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 50 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 adverse events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 50 (2.00%)
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Feb 2019
    Version 4.0, dated 28-Feb-2019

    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
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    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.

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