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    Clinical Trial Results:
    Fluoride in saliva during and after use of high-fluoride toothpaste

    Summary
    EudraCT number
    		 2020-000213-33
    Trial protocol
    		 DK  
    Global end of trial date
    23 Feb 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Feb 2022
    First version publication date
    03 Feb 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    14012020
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University
    Sponsor organisation address
    Vennelyst Boulevard 9, Aarhus, Denmark, 8000
    Public contact
    Line Staun Larsen, Department of Dentistry and Oral Health, +45 87168479, line.staun@dent.au.dk
    Scientific contact
    Line Staun Larsen, Department of Dentistry and Oral Health, +45 87168479, line.staun@dent.au.dk
    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
    05 Jan 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Feb 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Feb 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To explore how much regular brushing with 5,000 ppm fluoride toothpaste (Duraphat 5mg/g toothpaste) would elevate the salivary fluoride concentration compared to brushing with 1,450 ppm fluoride toothpaste, and to study how fast the salivary fluoride concentration would return to baseline levels following resumption of brushing with 1,450 ppm fluoride toothpaste.
    Protection of trial subjects
    N/A
    Background therapy
    		 N/A
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    01 Sep 2020
    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
    Denmark: 50
    Worldwide total number of subjects
    50
    EEA total number of subjects
    50
    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)
    50
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Students from Aarhus University who volunteered based on posters in campus canteens during the period from August 2020 to January 2021.

    Pre-assignment
    Screening details
    		 Adults (≥ 18 year), at least 20 teeth, non-pregnant and non-nursing, an unstimulated salivary flow rate of at least 1 ml/5 min.

    Period 1
    Period 1 title
    Overall trial: trial & wash-out phase (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    Identical tubes; toothpaste kits (one kit for each participant) were prepared and labelled by authorised pharmaceutical staff at the Hospital Pharmacy Central Denmark Region.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Test arm
    Arm description
    		 Trial phase: Participants used Duraphat 5mg/g tandpasta (toothpaste) twice daily for three weeks. Wash-out phase: Participants used 1,450 ppm fluoride toothpaste (Colgate® Fresh Gel; a cosmetic product, not medicine) twice daily for two weeks. (The phases were consecutive.)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Duraphat 5mg/g tandpasta
    Investigational medicinal product code
    Other name
    Duraphat® 5000 ppm Fluoride Toothpaste
    Pharmaceutical forms
    Toothpaste
    Routes of administration
    Oral use
    Dosage and administration details
    Toothbrushing twice daily (morning and evening) with 1 g of toothpaste.

    Investigational medicinal product name
    Colgate® Fresh Gel; a cosmetic product, not medicine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Toothpaste
    Routes of administration
    Oral use
    Dosage and administration details
    Toothbrushing twice daily (morning and evening) with 1 g of toothpaste.

    Arm title
    		 Control arm
    Arm description
    		 Trial phase: Participants used 1,450 ppm fluoride toothpaste (Colgate® Fresh Gel; a cosmetic product, not medicine) twice daily for three weeks. Wash-out phase: Participants continued to use 1,450 ppm fluoride toothpaste twice daily for two weeks. (The phases were consecutive.)
    Arm type
    		 Control arm

    Investigational medicinal product name
    Colgate® Fresh Gel; a cosmetic product, not medicine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Toothpaste
    Routes of administration
    Oral use
    Dosage and administration details
    Toothbrushing twice daily (morning and evening) with 1 g of toothpaste.

    Number of subjects in period 1
    		Test arm Control arm
    Started
    25
    25
    Completed
    24
    24
    Not completed
    1
    1
         Covid19-related circumstances
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Test arm
    Reporting group description
    		 Trial phase: Participants used Duraphat 5mg/g tandpasta (toothpaste) twice daily for three weeks. Wash-out phase: Participants used 1,450 ppm fluoride toothpaste (Colgate® Fresh Gel; a cosmetic product, not medicine) twice daily for two weeks. (The phases were consecutive.)

    Reporting group title
    Control arm
    Reporting group description
    		 Trial phase: Participants used 1,450 ppm fluoride toothpaste (Colgate® Fresh Gel; a cosmetic product, not medicine) twice daily for three weeks. Wash-out phase: Participants continued to use 1,450 ppm fluoride toothpaste twice daily for two weeks. (The phases were consecutive.)

    Reporting group values
    		 Test arm Control arm Total
    Number of subjects
    		 25 25 50
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 22.4 ( 1.5 ) 23.5 ( 2.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 20 17 37
        Male
    		 5 8 13

    End points

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    End points reporting groups
    Reporting group title
    Test arm
    Reporting group description
    		 Trial phase: Participants used Duraphat 5mg/g tandpasta (toothpaste) twice daily for three weeks. Wash-out phase: Participants used 1,450 ppm fluoride toothpaste (Colgate® Fresh Gel; a cosmetic product, not medicine) twice daily for two weeks. (The phases were consecutive.)

    Reporting group title
    Control arm
    Reporting group description
    		 Trial phase: Participants used 1,450 ppm fluoride toothpaste (Colgate® Fresh Gel; a cosmetic product, not medicine) twice daily for three weeks. Wash-out phase: Participants continued to use 1,450 ppm fluoride toothpaste twice daily for two weeks. (The phases were consecutive.)

    Primary: Salivary fluoride at day 0 (baseline) of the trial phase

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    End point title
    		 Salivary fluoride at day 0 (baseline) of the trial phase [1]
    End point description
    Saliva sampling days during the experimental period: day 0 (baseline), 7, 10, 14, 21, 22, 23, 24, 28 and 35. According to phases: day 0, 7, 10, 14 and 21 of the trial phase and day 1 ,2 ,3 ,7 and 14 of the wash-out phase. Day 21 of the trial phase is identical to day 0 in the wash-out phase.
    End point type
    Primary
    End point timeframe
    Day 0 (baseline) of the trial phase.
    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: Scientific paper, incl. detailed statistical analysis description, will be uploaded after publication.
    End point values
    		 Test arm Control arm
    Number of subjects analysed
    24
    24
    Units: parts per million
        geometric mean (confidence interval 95%)
    0.016 (0.012 to 0.021)
    0.014 (0.011 to 0.019)
    No statistical analyses for this end point

    Primary: Salivary fluoride at day 7 of the trial phase

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    End point title
    		 Salivary fluoride at day 7 of the trial phase [2]
    End point description
    End point type
    Primary
    End point timeframe
    Day 7 of the trial phase.
    Notes
    [2] - 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: Scientific paper, incl. detailed statistical analysis description, will be uploaded after publication.
    End point values
    		 Test arm Control arm
    Number of subjects analysed
    24
    24
    Units: parts per million
        geometric mean (confidence interval 95%)
    0.035 (0.025 to 0.048)
    0.020 (0.014 to 0.029)
    No statistical analyses for this end point

    Primary: Salivary fluoride at day 10 of the trial phase

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    End point title
    		 Salivary fluoride at day 10 of the trial phase [3]
    End point description
    End point type
    Primary
    End point timeframe
    Day 10 of the trial phase.
    Notes
    [3] - 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: Scientific paper, incl. detailed statistical analysis description, will be uploaded after publication.
    End point values
    		 Test arm Control arm
    Number of subjects analysed
    24
    24
    Units: Parts per million
        geometric mean (confidence interval 95%)
    0.036 (0.024 to 0.052)
    0.021 (0.015 to 0.030)
    No statistical analyses for this end point

    Primary: Salivary fluoride at day 14 of the trial phase

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    End point title
    		 Salivary fluoride at day 14 of the trial phase [4]
    End point description
    End point type
    Primary
    End point timeframe
    Day 14 of the trial phase.
    Notes
    [4] - 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: Scientific paper, incl. detailed statistical analysis description, will be uploaded after publication.
    End point values
    		 Test arm Control arm
    Number of subjects analysed
    24
    24
    Units: parts per million
        geometric mean (confidence interval 95%)
    0.032 (0.021 to 0.049)
    0.017 (0.012 to 0.024)
    No statistical analyses for this end point

    Primary: Salivary fluoride at day 21 of the trial phase (end of trial phase)

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    End point title
    		 Salivary fluoride at day 21 of the trial phase (end of trial phase) [5]
    End point description
    End point type
    Primary
    End point timeframe
    Day 21 of trial phase.
    Notes
    [5] - 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: Scientific paper, incl. detailed statistical analysis description, will be uploaded after publication.
    End point values
    		 Test arm Control arm
    Number of subjects analysed
    24
    24
    Units: parts per million
        geometric mean (confidence interval 95%)
    0.044 (0.029 to 0.066)
    0.023 (0.015 to 0.034)
    No statistical analyses for this end point

    Primary: Salivary fluoride at day 1 of the wash-out phase

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    End point title
    		 Salivary fluoride at day 1 of the wash-out phase [6]
    End point description
    End point type
    Primary
    End point timeframe
    Day 1 of the wash-out phase.
    Notes
    [6] - 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: Scientific paper, incl. detailed statistical analysis description, will be uploaded after publication.
    End point values
    		 Test arm Control arm
    Number of subjects analysed
    24
    24
    Units: parts per million
        geometric mean (confidence interval 95%)
    0.025 (0.016 to 0.039)
    0.015 (0.011 to 0.020)
    No statistical analyses for this end point

    Primary: Salivary fluoride at day 2 of the wash-out phase

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    End point title
    		 Salivary fluoride at day 2 of the wash-out phase [7]
    End point description
    End point type
    Primary
    End point timeframe
    Day 2 of the wash-out phase.
    Notes
    [7] - 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: Scientific paper, incl. detailed statistical analysis description, will be uploaded after publication.
    End point values
    		 Test arm Control arm
    Number of subjects analysed
    24
    24
    Units: parts per million
        geometric mean (confidence interval 95%)
    0.023 (0.014 to 0.036)
    0.019 (0.014 to 0.025)
    No statistical analyses for this end point

    Primary: Salivary fluoride at day 3 of the wash-out phase

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    End point title
    		 Salivary fluoride at day 3 of the wash-out phase [8]
    End point description
    End point type
    Primary
    End point timeframe
    Day 3 of the wash-out phase.
    Notes
    [8] - 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: Scientific paper, incl. detailed statistical analysis description, will be uploaded after publication.
    End point values
    		 Test arm Control arm
    Number of subjects analysed
    24
    24
    Units: parts per million
        geometric mean (confidence interval 95%)
    0.024 (0.016 to 0.038)
    0.018 (0.013 to 0.025)
    No statistical analyses for this end point

    Primary: Salivary fluoride at day 7 of the wash-out phase

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    End point title
    		 Salivary fluoride at day 7 of the wash-out phase [9]
    End point description
    End point type
    Primary
    End point timeframe
    Day 7 of the wash-out phase.
    Notes
    [9] - 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: Scientific paper, incl. detailed statistical analysis description, will be uploaded after publication.
    End point values
    		 Test arm Control arm
    Number of subjects analysed
    24
    24
    Units: parts per million
        geometric mean (confidence interval 95%)
    0.023 (0.016 to 0.034)
    0.025 (0.016 to 0.039)
    No statistical analyses for this end point

    Primary: Salivary fluoride at day 14 of the wash-out phase (end of the wash-out phase)

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    End point title
    		 Salivary fluoride at day 14 of the wash-out phase (end of the wash-out phase) [10]
    End point description
    End point type
    Primary
    End point timeframe
    Day 14 of the wash-out phase.
    Notes
    [10] - 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: Scientific paper, incl. detailed statistical analysis description, will be uploaded after publication.
    End point values
    		 Test arm Control arm
    Number of subjects analysed
    24
    24
    Units: parts per million
        geometric mean (confidence interval 95%)
    0.025 (0.017 to 0.036)
    0.016 (0.011 to 0.023)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During the trial, from inclusion of the first participant to the end of trial.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 N/A
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Test arm
    Reporting group description
    		 Trial phase: Participants used Duraphat 5mg/g tandpasta (toothpaste) twice daily for three weeks. Wash-out phase: Participants used 1,450 ppm fluoride toothpaste (Colgate® Fresh Gel; a cosmetic product, not medicine) twice daily for two weeks. (The phases were consecutive.)

    Reporting group title
    Control arm
    Reporting group description
    		 Trial phase: Participants used 1,450 ppm fluoride toothpaste (Colgate® Fresh Gel; a cosmetic product, not medicine) twice daily for three weeks. Wash-out phase: Participants continued to use 1,450 ppm fluoride toothpaste twice daily for two weeks. (The phases were consecutive.)

    Serious adverse events
    		 Test arm Control arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Test arm Control arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    Vascular disorders
    Migraine
    Additional description: A participant, with no history of migraines, reported to have had a migraine for two days (day 12 and 13 in the trial phase).
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Rash
    Additional description: Skin rash in the ear, neck and thorax areas developed two weeks into the trial phase.
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
         occurrences all number
    1
    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
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