Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Seal or Varnish? A Randomised Trial To Determine The Relative Cost And Effectiveness Of Pit And Fissure Sealants And Fluoride Varnish In Preventing Dental Decay

    Summary
    EudraCT number
    		 2010-023476-23
    Trial protocol
    		 GB  
    Global end of trial date
    21 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jan 2019
    First version publication date
    06 Jan 2019
    Other versions
    Summary report(s)
    		 HTA Final report v2.0
    Appendices

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    SPON766-09
    Additional study identifiers
    ISRCTN number
    		 ISRCTN17029222
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cardiff University
    Sponsor organisation address
    7th Floor, 30-36 Newport Road, Cardiff, United Kingdom, CF24 0DE
    Public contact
    Ivor Chestnutt, Cardiff University, 02920 746680, ChestnuttIG@cardiff.ac.uk
    Scientific contact
    Ivor Chestnutt, Cardiff University, 02920 746680, ChestnuttIG@cardiff.ac.uk
    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
    12 Apr 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective for this study was to: To compare the clinical effectiveness of Pit and Fissure Sealants (PFS) and Fluoride Varnish (FV) in preventing dental caries in first permanent molars in 6-7 year-olds, as determined by: • The proportion of children developing caries on any one of up to four treated first permanent molars • The number of treated first permanent molar teeth caries-free at 36 months
    Protection of trial subjects
    For participants receiving either the Pit and Fissue Sealant or Fluoride Varnish, preventing dental caries in their first permanent molar teeth outweighed the risk of the potential side effects from either treatment. FV application is not recommended in children with severe allergic tendencies (i.e. those who have previously been hospitalised for asthma). We actively sought out and excluded such children from the study.
    Background therapy
    		 There is no background therapy used in this trial.
    Evidence for comparator
    		 Pit and fissure sealants comprise a Bis-GMA resin, which is applied to the occlusal surface of the tooth using acid-etch technology. They work by physically obliterating the pit and fissure system which harbours cariogenic organisms and thereby inhibit the initiation of caries. First developed in the 1960s, they are an established technology and widely used in clinical practice. Numerous studies have investigated the clinical effectiveness of fissure sealants and this has been the subject of a recent Cochrane review. A meta-analysis of seven studies comparing sealed teeth to untreated controls demonstrated caries reductions ranging from 87% at 12 months to 60% at 48-54 months (Ahovuo-Saloranta et al., 2008). Fluoride varnishes have also been marketed since the 1960s and comprise a topical medication which is painted onto the tooth surface. They contain a high concentration of fluoride (22,600 ppm) and are licensed for application by dental professionals. The varnish forms a quick-setting base which subsequently releases fluoride. Fluoride acts to prevent caries by inhibiting the demineralisation and encouraging the remineralisation of dental enamel. A Cochrane review suggested a pooled prevented fraction estimate of 46% (95%CI 30%-63%) when fluoride varnish is tested against no treatment controls (Marhino et al., 2002).
    Actual start date of recruitment
    07 Jul 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 1015
    Worldwide total number of subjects
    1015
    EEA total number of subjects
    1015
    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)
    1015
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were recruited from primary schools in 'Communities first' areas in South Wales as designated by the Welsh assembley government. Recruitment ocurred between July 2011 and September 2012.

    Pre-assignment
    Screening details
    		 Invited participants who provided consent to participation were screened for adherence to inclusion/ exclusion criteria through a returned medical history form and subsequently via baseline dental examination.

    Pre-assignment period milestones
    Number of subjects started
    		 1406 [1]
    Intermediate milestone: Number of subjects
    Assessment of medical history: 1406
    Intermediate milestone: Number of subjects
    Screening assessment: 1303
    Number of subjects completed
    		 1015

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 2
    Reason: Number of subjects
    		 Physician decision: 103
    Reason: Number of subjects
    		 Deemed ineligble: 286
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Participants returned consent and medical history prior to assessment for inclusion in the trial. Only those that were deemed eligible were officially enrolled on the study.
    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Varnish
    Arm description
    		 Participants allocated to this arm received 6 monthly treatments of fluoride varnish applied to first permanent mo;ars included in the trial.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Duraphat
    Investigational medicinal product code
    PL 00049/0042
    Other name
    Pharmaceutical forms
    Dental suspension
    Routes of administration
    Dental use
    Dosage and administration details
    Fluoride varnish (FV) was supplied as 10 ml tubes (50 mg/ml dental suspension, equivalent to 22,600ppm fluoride) for multiple applications and applied topically as a thin layer to the pits, fissures and smooth surfaces of eligible teeth. As per the Duraphat Summary of Product Characteristics (SmPC), dosage per single application did not exceed 0.4 ml. Initial application of FV will occured within 2 weeks of the baseline dental examination, and was performed by a suitably qualified and trained dental hygienist according to the conventional clinical protocol established by the Community Dental Service. FV was re-applied at 6, 12, 18, 24, and 30 months ( maximum of six applications).

    Arm title
    		 Sealant
    Arm description
    		 Participants allocated to this arm received a pit and fissure sealant on the occlusal surface of any erupted first permanent moar included in the trial.
    Arm type
    		 Non-IMP comparator

    Investigational medicinal product name
    Delton Light Curing Pit & Fissure Sealant
    Investigational medicinal product code
    CE0086
    Other name
    Pharmaceutical forms
    Dental gel
    Routes of administration
    Dental use
    Dosage and administration details
    The Pit and Fissure Sealant (PFS) used for evaluation in the study was Delton Light Curing Opaque Pit & Fissure Sealant, which is the same PFS used in the current school based Designed to Smile programme. PFS will be supplied as 2.7 ml bottles for multiple applications and applied topically as a thin layer to occlusal surface of eligible teeth. Initial application of PFS will occur within 2 weeks of the baseline dental examination, and will be performed by a suitably qualified and trained dental hygienist according to the conventional clinical protocol established by the Community Dental Service. The condition of the PFS will be re-examined at 6, 12, 18, 24, and 30 months, and will be re-applied if the existing sealant has become detached, or if attachment is considered insufficient.

    Number of subjects in period 1
    		Varnish Sealant
    Started
    501
    514
    Completed
    501
    514
    Period 2
    Period 2 title
    36 Months
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [2]
    Blinding implementation details
    Only dental assessors were blind to treatment allocation. Assessors did not have access to any of the treatment records or trial documentation in order to maintain their blind. However, it may have been possible for the assessors to identifythose children treated with pit and fissure sealant as this would be apparent on inspection.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sealant
    Arm description
    		 -
    Arm type
    		 Non-IMP comparator

    Investigational medicinal product name
    Delton Light Curing Pit & Fissure Sealant
    Investigational medicinal product code
    CE0086
    Other name
    Pharmaceutical forms
    Dental gel
    Routes of administration
    Dental use
    Dosage and administration details
    The Pit and Fissure Sealant (PFS) used for evaluation in the study was Delton Light Curing Opaque Pit & Fissure Sealant, which is the same PFS used in the current school based Designed to Smile programme. PFS will be supplied as 2.7 ml bottles for multiple applications and applied topically as a thin layer to occlusal surface of eligible teeth. Initial application of PFS will occur within 2 weeks of the baseline dental examination, and will be performed by a suitably qualified and trained dental hygienist according to the conventional clinical protocol established by the Community Dental Service. The condition of the PFS will be re-examined at 6, 12, 18, 24, and 30 months, and will be re-applied if the existing sealant has become detached, or if attachment is considered insufficient.

    Arm title
    		 Varnish
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Duraphat
    Investigational medicinal product code
    PL 00049/0042
    Other name
    Pharmaceutical forms
    Dental suspension
    Routes of administration
    Dental use
    Dosage and administration details
    Fluoride varnish (FV) was supplied as 10 ml tubes (50 mg/ml dental suspension, equivalent to 22,600ppm fluoride) for multiple applications and applied topically as a thin layer to the pits, fissures and smooth surfaces of eligible teeth. As per the Duraphat Summary of Product Characteristics (SmPC), dosage per single application did not exceed 0.4 ml. Initial application of FV will occured within 2 weeks of the baseline dental examination, and was performed by a suitably qualified and trained dental hygienist according to the conventional clinical protocol established by the Community Dental Service. FV was re-applied at 6, 12, 18, 24, and 30 months ( maximum of six applications).

    Notes
    [2] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: The physical nature of the technologies under test limited the scope for blinding. Both the participant and the dental hygenist were aware of the treatment provided. The dentist undertaking the clinical ental examination as baseline, 12, 24 and 36 months was not informed of the arm to which the participant had been randomised. However, the presence or absence of fissure sealants at assessment would obviously indicate the likely treatment recevied.
    Number of subjects in period 2
    		Sealant Varnish
    Started
    514
    501
    12 months
    484
    474
    24 months
    468
    452
    36 months
    418
    417
    Completed
    418
    417
    Not completed
    96
    84
         Consent withdrawn by subject
    5
    6
         Missed final assessment (primary outcome)
    -
    14
         Missed assessment (primary outcome)
    16
    -
         Lost to follow-up
    75
    64

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Varnish
    Reporting group description
    		 Participants allocated to this arm received 6 monthly treatments of fluoride varnish applied to first permanent mo;ars included in the trial.

    Reporting group title
    Sealant
    Reporting group description
    		 Participants allocated to this arm received a pit and fissure sealant on the occlusal surface of any erupted first permanent moar included in the trial.

    Reporting group values
    		 Varnish Sealant Total
    Number of subjects
    		 501 514 1015
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 501 514 1015
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 266 277 543
        Male
    		 235 237 472
    Number of children with dentine caries in the primary dentition (d4-6)
    This is the number of children at baseline who were assessed as having caries into dentine in their primary dentition (baby teeth)
    Units: Subjects
        Children with dentine caries
    		 266 286 552
        Children without dentine caries
    		 235 228 463
    Number of children with dentine caries in the primary dentition (d4-6mft)
    Number of children assessed as having dentine into caries in the primary dentition at the tooth level
    Units: Subjects
        Dentine caries in the primary dentition (d4-6mft)
    		 339 342 681
        No dentine caries in primary dentition (d4-6mft)
    		 162 172 334
    Children with untreated dentine caries in any First Permanent Molar (D4-6)
    The number of cihldren assessed as having untreated caries into dentine at the surface level on any one first permanent molar (FPM)
    Units: Subjects
        Untreated dentine caries on any FMP (D4-6)
    		 23 22 45
        Without untreated dentine caries on any FMP (D4-6)
    		 478 492 970
    Children with dentine caries in any first permanent molar (D4-6MFT)
    Number of children assessed as having caries into dentine at the tooth level in any first permanent molar (FPM).
    Units: Subjects
        Dentine caries in any FPM (D4-6MFT)
    		 31 27 58
        Without dentine caries in any FPM (D4-6MFT)
    		 470 487 957

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Varnish
    Reporting group description
    		 Participants allocated to this arm received 6 monthly treatments of fluoride varnish applied to first permanent mo;ars included in the trial.

    Reporting group title
    Sealant
    Reporting group description
    		 Participants allocated to this arm received a pit and fissure sealant on the occlusal surface of any erupted first permanent moar included in the trial.
    Reporting group title
    Sealant
    Reporting group description
    		 -

    Reporting group title
    Varnish
    Reporting group description
    		 -

    Primary: Number of children developiong dentine caries on any FPM

    		 Close Top of page
    End point title
    		 Number of children developiong dentine caries on any FPM
    End point description
    The proportion of children with dentine caries (D4-6MFT) on any FMP in the trial at 36 month examination
    End point type
    Primary
    End point timeframe
    36 months
    End point values
    		 Sealant Varnish
    Number of subjects analysed
    418
    417
    Units: D4-6MFT
        No dentinal caries on any first permanent molar
    336
    344
        Dentine caries (D4-6MFT) on at least one FPM
    82
    73
    Statistical analysis title
    		 Primary Outcome
    Comparison groups
    Sealant v Varnish
    Number of subjects included in analysis
    835
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 1.21
    Variability estimate
    Standard deviation
    Statistical analysis title
    		 Primary Outcome ( adjusted for school attended)
    Comparison groups
    Sealant v Varnish
    Number of subjects included in analysis
    835
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 1.21
    Variability estimate
    Standard deviation

    Secondary: Number of children developing dentine caries at 36 months by number of FPM in trial

    		 Close Top of page
    End point title
    		 Number of children developing dentine caries at 36 months by number of FPM in trial
    End point description
    End point type
    Secondary
    End point timeframe
    36 months
    End point values
    		 Sealant Varnish
    Number of subjects analysed
    418
    417
    Units: D4-6MFT
        No caries on any FPM
    336
    344
        Caries on 1 FPM
    53
    43
        Caries on 2 FPM
    22
    17
        Caries on 3 FPM
    5
    9
        Caries on 4 FPM
    2
    4
    Statistical analysis title
    		 FPM with dentine caries, restoration or extraction
    Statistical analysis description
    Ordinal regression analysis of the number of FPM with dentine caries, a restoration or extracted but to caries (D4-6MFT) at 36 months by trial intervention arm.
    Comparison groups
    Sealant v Varnish
    Number of subjects included in analysis
    835
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Ordinal Regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 1.2
    Variability estimate
    Standard deviation

    Secondary: Number of surfaces with dentine caries per participant

    		 Close Top of page
    End point title
    		 Number of surfaces with dentine caries per participant
    End point description
    The number of FPM surfaces per particiant developing dentine caries at 36 months
    End point type
    Secondary
    End point timeframe
    36 months
    End point values
    		 Sealant Varnish
    Number of subjects analysed
    418
    417
    Units: D4-6MFS
        D4-6 MFS=0
    336
    344
        1 with caries
    46
    36
        2 with caries
    14
    17
        3 with caries
    11
    7
        4 with caries
    3
    6
        5 with caries
    4
    4
        6 with caries
    1
    1
        7 with caries
    2
    0
        10 with caries
    1
    0
        20 with caries
    0
    2
    Statistical analysis title
    		 Number of FPM surfaces with dentine caries
    Statistical analysis description
    Ordinal regression ananlysis of the number of FPM surfaces with dentine caries (D4-6MFS) at 36 months by trial arm
    Comparison groups
    Sealant v Varnish
    Number of subjects included in analysis
    835
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Ordinal Regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 1.19

    Secondary: Association of treatment visits

    		 Close Top of page
    End point title
    		 Association of treatment visits
    End point description
    The number of treatment visits attended by each child who also underwent a final clinical examination at 36 months.
    End point type
    Secondary
    End point timeframe
    36 months
    End point values
    		 Sealant Varnish
    Number of subjects analysed
    418
    417
    Units: Number of treatment visits
        1 treatment visit, No FPM with DMFT
    1
    0
        2 treatment visits, No FPM with DMFT
    0
    0
        3 treatment visits, No FPM with DMFT
    1
    4
        4 treatment visits, No FPM with DMFT
    13
    11
        5 treatment visits, No FPM with DMFT
    75
    80
        6 treatment visits, No FPM with DMFT
    246
    249
        1 treatment visit, at least one FPM with DMFT
    0
    0
        2 treatment visits, at least one FPM with DMFT
    0
    1
        3 treatment visits, at least one FPM with DMFT
    1
    0
        4 treatment visits, at least one FPM with DMFT
    3
    4
        5 treatment visits, at least one FPM with DMFT
    17
    16
        6 treatment visits, at least one FPM with DMFT
    61
    52
    Statistical analysis title
    		 Effects of treatment adherence
    Statistical analysis description
    To determine the effects of adherence to the scheduled number of treatment visits, a Complier Average Causal Effect analysis was conducted. As Fissure Sealant was the standard treatment in the Design to Smile program prior to the trial, this was assumed to be the control with treatment visits set to a constant (zero).
    Comparison groups
    Sealant v Varnish
    Number of subjects included in analysis
    835
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Complier Average Causual Effect
    Parameter type
    		 Efficacy coefficient
    Point estimate
    -0.005
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.014
         upper limit
    		 0.004

    Secondary: Adherence to pre-specified treatment window

    		 Close Top of page
    End point title
    		 Adherence to pre-specified treatment window
    End point description
    End point type
    Secondary
    End point timeframe
    36 months
    End point values
    		 Sealant Varnish
    Number of subjects analysed
    418
    417
    Units: Number of treatments outside window
        0 treatments outside window
    302
    296
        1 treatment outside window
    106
    112
        2 treatment outside window
    7
    5
        3 treatment outside window
    1
    3
        4 treatment outside window
    2
    0
        5 treatment outside window
    0
    1
    Statistical analysis title
    		 Effect of number of treatments outside of window
    Statistical analysis description
    To test for the effect of adherence to the treatmnt window, a binary indicator was added to the primary model which categorise the participants as having received: 1) All of their treatment visits within window 2) At least one visit out of window
    Comparison groups
    Sealant v Varnish
    Number of subjects included in analysis
    835
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.052
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.43
         upper limit
    		 1

    Secondary: Enamel caries on any FPM in the trial

    		 Close Top of page
    End point title
    		 Enamel caries on any FPM in the trial
    End point description
    The proportion of children with D1-6MFT (caries into enamel) on any FPM in the trial at 36 months
    End point type
    Secondary
    End point timeframe
    36 months
    End point values
    		 Sealant Varnish
    Number of subjects analysed
    418
    417
    Units: D1-6MFT
        No caries on any FPM
    95
    135
        Caries D1-6MFT on at least one FPM
    323
    282
    Statistical analysis title
    		 Effect of treatment on caries in enamel
    Comparison groups
    Sealant v Varnish
    Number of subjects included in analysis
    835
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.41
         upper limit
    		 0.78

    Secondary: Whole mouth caries experience

    		 Close Top of page
    End point title
    		 Whole mouth caries experience
    End point description
    Total number of permanent teeth, per participant, affected by D4-6MFT
    End point type
    Secondary
    End point timeframe
    36 Months
    End point values
    		 Sealant Varnish
    Number of subjects analysed
    418
    417
    Units: NUmber of teeth
        0 permanent teeth with D4-6MFT
    326
    334
        1 permanent teeth with D4-6MFT
    56
    42
        2 permanent teeth with D4-6MFT
    27
    26
        3 permanent teeth with D4-6MFT
    5
    11
        4 permanent teeth with D4-6MFT
    3
    4
        6 permanent teeth with D4-6MFT
    1
    0
    Statistical analysis title
    		 Impact of trial treatment on all permanent teeth
    Statistical analysis description
    To examine the difference in the number of affected teeth Poisson and Binomial distribution modelling was carried out.
    Comparison groups
    Sealant v Varnish
    Number of subjects included in analysis
    835
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Poisson regression
    Parameter type
    		 Incident Rate Ratio
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 1.2
    Statistical analysis title
    		 Copy of Impact of trial treatment on all perman...
    Statistical analysis description
    To examine the difference in the number of affected teeth Poisson and Binomial distribution modelling was carried out.
    Comparison groups
    Sealant v Varnish
    Number of subjects included in analysis
    835
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Negative Binomial regression
    Parameter type
    		 Incident Rate Ratio
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.46
    Statistical analysis title
    		 Copy of Copy of Impact of trial treatment on al...
    Statistical analysis description
    To examine the difference in the number of affected teeth Poisson and Binomial distribution modelling was carried out.
    Comparison groups
    Sealant v Varnish
    Number of subjects included in analysis
    835
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Zero inflated poisson regression
    Parameter type
    		 Incident Rate Ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.35
    Statistical analysis title
    		 Copy of Copy of Copy of Impact of trial treatme...
    Statistical analysis description
    To examine the difference in the number of affected teeth Poisson and Binomial distribution modelling was carried out.
    Comparison groups
    Sealant v Varnish
    Number of subjects included in analysis
    835
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 0 inflated negative binomial regression
    Parameter type
    		 Incident Rate Ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 1.35

    Secondary: Number of children developing dentine caries on any treated FPM at 12 months

    		 Close Top of page
    End point title
    		 Number of children developing dentine caries on any treated FPM at 12 months
    End point description
    The proportion of children with caries (D4-6MFT) on any treated FPM in the trial at the 12 month annual examination
    End point type
    Secondary
    End point timeframe
    12 month examination
    End point values
    		 Sealant Varnish
    Number of subjects analysed
    450
    444
    Units: D4-6MFT
        No caries on any FPM
    414
    407
        Caries on at least one FPM
    36
    37
    Statistical analysis title
    		 Proportion of children with caries
    Statistical analysis description
    Proportion of children with caries (D4-6MFT) on any treated FPM at 12 months
    Comparison groups
    Sealant v Varnish
    Number of subjects included in analysis
    894
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.21

    Secondary: Number of children developing dentine caries on any treated FPM at 24 months

    		 Close Top of page
    End point title
    		 Number of children developing dentine caries on any treated FPM at 24 months
    End point description
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    		 Sealant Varnish
    Number of subjects analysed
    439
    424
    Units: D4-6MFT
        No caries on any FPM
    378
    361
        Caries on at least one FPM
    61
    63
    Statistical analysis title
    		 Proportion of children with caries
    Statistical analysis description
    Proportion of children with caries (D4-6MFT) on any treated FPM at 24 months
    Comparison groups
    Sealant v Varnish
    Number of subjects included in analysis
    863
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.41
         upper limit
    		 2.62

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events were monitored from baseline treatment (0 months) until the final examination (36 months)
    Adverse event reporting additional description
    No adverse events were reported in either arm for the duration o the trial.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Sealant
    Reporting group description
    		 All participants randomised to receive Pit and Fissure Sealant

    Reporting group title
    Varnish
    Reporting group description
    		 All participants randomised to receive fluoride varnish

    Serious adverse events
    		 Sealant Varnish
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 514 (0.00%)
    0 / 502 (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
    		 Sealant Varnish
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 514 (0.00%)
    0 / 502 (0.00%)
    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: The treatments studied in this trial are licensed and well tolerated. No serious adverse events were reported

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Jul 2011
    Amendment included re-wording of primary objective as requested by ethics committee Change to timing of participant ID assignation Changes to methods of approach for data colelction; use of home based questionnaires as opposed to telephone administration or via semi-structured questionnaires Revisions to frequency and of method of clinical, health economics and process evaluation assessments Clarification of adverse event assessment and adverse event reporting

    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/28613154
    http://www.ncbi.nlm.nih.gov/pubmed/28394709
    http://www.ncbi.nlm.nih.gov/pubmed/23167481
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Thu May 02 19:18:18 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA