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    Clinical Trial Results:
    Prevention and treatment of initial rotcaries among elderly in Skåne.

    Summary
    EudraCT number
    		 2015-005300-29
    Trial protocol
    		 SE  
    Global end of trial date
    19 Feb 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Oct 2024
    First version publication date
    25 Oct 2024
    Other versions
    Summary report(s)
    		 Effect of a single application of silver diamine fluoride on root caries after 12 months in institutionalised older adults—A randomised clinical trial

    Trial information

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    Trial identification
    Sponsor protocol code
    SDF1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Malmö University
    Sponsor organisation address
    20506 Malmö, Malmö, Sweden, 20506 Malmö
    Public contact
    Dan Ericson, Malmö University, Faculty of Odontology, +46 0705432497, dan.ericson@mau.se
    Scientific contact
    Dan Ericson, Malmö University, Faculty of Odontology, +46 0705432497, dan.ericson@mau.se
    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
    19 Feb 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Feb 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Feb 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this randomized, single-blinded, placebo-controlled trial was to evaluate the additive effect of a single annual application of SDF for prevention and treatment of incipient root caries in older adult nursing home residents.
    Protection of trial subjects
    The cleaned root surfaces of the included teeth were dried with cotton gauze and a dry field was created using cotton rolls. The adjacent gingiva was protected with petroleum jelly. After mouth rinsing following the first treatment at baseline, the patients were asked to describe their experiences of taste, smell, or other sensations during application. Their responses were recorded, along with the tooth surface color and gingival status. Study procedures and protocols were scrutinized by the study monitor every six months. After 129 (36%) of the participants had been evaluated (by August 2018), independent data and safety monitoring were conducted with respect to efficacy and safety, in order to identify any differences between the study groups that would warrant early termination of the trial.
    Background therapy
    		 All participants received routine oral healthcare from the dental care provider, in accordance with risk assessment based on yearly oral health examinations. The individualized procedures included professional tooth cleaning, fluoride varnish application, and dietary and oral hygiene instruction in relation to assessed caries risk. The participants received supervised personal oral hygiene procedures including fluoride toothpaste because they were care-dependent.
    Evidence for comparator
    		 See below
    Actual start date of recruitment
    09 Jan 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
    Sweden: 356
    Worldwide total number of subjects
    356
    EEA total number of subjects
    356
    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)
    0
    From 65 to 84 years
    92
    85 years and over
    264

    Subject disposition

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    Recruitment
    Recruitment details
    		 Eligible participants were recruited from January 2017 to October 2018 in nursing homes in Skåne.

    Pre-assignment
    Screening details
    		 Eligible individuals were identified during routine dental examination visits. The responsible medical nurse advised whether the individual was able to understand and to make an informed decision to consent to participation. Each received oral and written information about the study.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    Placebo application.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Silver diamine fluoride
    Arm description
    		 Application of Silver diamine fluoride
    Arm type
    		 Experimental

    Investigational medicinal product name
    Advantage Arrest Silver Diamine Fluoride 38%, Advantage Arrest, LLC, Redmond, OR 97756, USA, Lot 16 152
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dental solution
    Routes of administration
    Dental use
    Dosage and administration details
    The cleaned root surfaces of the included teeth were dried with cotton gauze and a dry field was created using cotton rolls. The adjacent gingiva was protected with petroleum jelly. Participants were randomly assigned to receive SDF (Advantage Arrest Silver Diamine Fluoride 38%, Advantage Arrest, LLC, Redmond, OR 97756, USA, Lot 16 152) or placebo (tap water), applied sparingly on root surfaces with a micro applicator brush and left undisturbed for 1 minute. Participants were then allowed to rinse with water.

    Arm title
    		 Placebo
    Arm description
    		 Placebo (tap water)
    Arm type
    		 Placebo

    Investigational medicinal product name
    water
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dental suspension
    Routes of administration
    Dental use
    Dosage and administration details
    water

    Number of subjects in period 1
    		Silver diamine fluoride Placebo
    Started
    174
    182
    Completed
    135
    138
    Not completed
    39
    44
         Lost to follow-up
    39
    44

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 Care home residents

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 356 356
    Age categorical
    Subjects were 70 years and older
    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)
    		 0 0
        From 65-84 years
    		 92 92
        85 years and over
    		 264 264
    Age continuous
    Individuals fulfilling trial 356
    Units: years
        arithmetic mean (standard deviation)
    		 88 ( 6.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 249 249
        Male
    		 107 107

    End points

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    End points reporting groups
    Reporting group title
    Silver diamine fluoride
    Reporting group description
    		 Application of Silver diamine fluoride

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo (tap water)

    Primary: root caries change score

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    End point title
    		 root caries change score
    End point description
    The status at surface level was classified as new caries or caries progression (+1), no change (0), or caries regression/inactivation (−1) and the root caries change score is the summation of the individual surface scores within the subject.
    End point type
    Primary
    End point timeframe
    over all study
    End point values
    		 Silver diamine fluoride Placebo
    Number of subjects analysed
    138
    135
    Units: subjects
        Root caries change score +3
    1
    0
        Root caries change score +2
    6
    3
        Root caries change score +1
    11
    10
        Root caries change score 0
    110
    108
        Root caries change score -1
    8
    12
        Root caries change score -2
    2
    2
    Statistical analysis title
    		 Root surface status at baseline and after 12 month
    Statistical analysis description
    Comparison of root change score between SDF and Placebo
    Comparison groups
    Silver diamine fluoride v Placebo
    Number of subjects included in analysis
    273
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    At baseline directly after treatment. At 6 month monitor report.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    240531
    Reporting groups
    Reporting group title
    Dental hygienist operator
    Reporting group description
    		 Dental hygienist delivering treatment

    Reporting group title
    Study monitor
    Reporting group description
    		 Study monitor

    Serious adverse events
    		 Dental hygienist operator Study monitor
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 356 (0.00%)
    0 / 356 (0.00%)
         number of deaths (all causes)
    0
    75
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Dental hygienist operator Study monitor
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 356 (0.56%)
    0 / 356 (0.00%)
    Injury, poisoning and procedural complications
    Gingival erosion
         subjects affected / exposed
    2 / 356 (0.56%)
    0 / 356 (0.00%)
         occurrences all number
    2
    0

    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/36404644
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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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