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    Clinical Trial Results:
    Adjunctive effect of mouthrinse on treatment of peri‐implant mucositis using mechanical debridement: a randomized clinical trial

    Summary
    EudraCT number
    		 2014-004825-42
    Trial protocol
    		 NL  
    Global end of trial date
    09 Feb 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 May 2020
    First version publication date
    11 May 2020
    Other versions
    Summary report(s)
    		 Abstract

    Trial information

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    Trial identification
    Sponsor protocol code
    ACTA, Amsterdam
    Additional study identifiers
    ISRCTN number
    		 ISRCTN52990000
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Effect of Delmopinol on treatment of inflammation : NL 5159
    Sponsors
    Sponsor organisation name
    ACTA
    Sponsor organisation address
    Gustav Mahlerlaan 3004, Amsterdam, Netherlands, 1081 LA
    Public contact
    Department of Oral Implantology, ACTA, 0031 205980297, info.implantologie@acta.nl
    Scientific contact
    Department of Oral Implantology, Academic Centre for Dentistry, 0031 205980297, j.philip@acta.nl
    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
    25 Sep 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Feb 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study effect of delmopinol hydrochloride (DEL) in comparison with chlorhexidine digluconate (CHX) and a placebo (PLA) in addition to non-surgical mechanical debridement in patients with peri-implant mucositis.
    Protection of trial subjects
    Standard treatment was provided to each participant.Patients could discontinue use of mouthrinse at any point of time.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Apr 2017
    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
    Netherlands: 89
    Worldwide total number of subjects
    89
    EEA total number of subjects
    89
    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)
    52
    From 65 to 84 years
    37
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The inclusion criteria of the study were: (a) individuals 18 years of age and older with at least one titanium dental implant, (b) single/three-unit fixed implant-supported restoration with bleeding on gentle probing (BOP) and/pus and (c) implant in function for at least 1 year, with no progressive radiographic bone loss.

    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
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DELMOPINOL
    Arm description
    		 Mechanical debridement combined with delmopinol mouthrinse
    Arm type
    		 Experimental

    Investigational medicinal product name
    delmopinol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Mouth rinsing 10 ml twice a day in addition to their regular oral hygiene practice

    Arm title
    		 CHLORHEXIDINE
    Arm description
    		 Mechanical debridement combined with Chlorhexidine mouthrinse.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    CHLORHEXIDINE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Mouth rinsing 0.2% CHX solution 10 ml twice a day in addition to their regular oral hygiene practice

    Arm title
    		 PLACEBO
    Arm description
    		 Placebo mouthrinse
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo mouthrinse
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Mouth rinsing Placebo mouthrinse 10 ml twice a day in addition to their regular oral hygiene practice

    Number of subjects in period 1
    		DELMOPINOL CHLORHEXIDINE PLACEBO
    Started
    31
    30
    28
    Completed
    31
    30
    28

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    DELMOPINOL
    Reporting group description
    		 Mechanical debridement combined with delmopinol mouthrinse

    Reporting group title
    CHLORHEXIDINE
    Reporting group description
    		 Mechanical debridement combined with Chlorhexidine mouthrinse.

    Reporting group title
    PLACEBO
    Reporting group description
    		 Placebo mouthrinse

    Primary: Changes in mean mBI

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    End point title
    		 Changes in mean mBI
    End point description
    End point type
    Primary
    End point timeframe
    Baseline, 1 and 3 months after treatment
    End point values
    		 DELMOPINOL CHLORHEXIDINE PLACEBO
    Number of subjects analysed
    31
    30
    28
    Units: 1
        arithmetic mean (standard deviation)
    1.00 ( 0.49 )
    1.03 ( 0.44 )
    1.08 ( 0.52 )
    Statistical analysis title
    		 Changes mean IBOP
    Comparison groups
    DELMOPINOL v CHLORHEXIDINE v PLACEBO
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    After baseline anytime and otherwise at 1 and 3 months after treatment.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Frequency threshold for reporting non-serious adverse events: 2%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Side effects reported were expected and there were no serious adverse events.

    More information

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    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32315444
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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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