<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01674933</url>
  </required_header>
  <id_info>
    <org_study_id>GC12CO201</org_study_id>
    <nct_id>NCT01674933</nct_id>
  </id_info>
  <brief_title>Fluoride Varnish For Childsmile Nursery School Attenders</brief_title>
  <acronym>PT@3</acronym>
  <official_title>Comparison Of The Caries-Protective Effect Of Fluoride Varnish (Duraphat®) With Treatment As Usual In Nursery School Attendees Receiving Preventive Oral Health Support Through The Childsmile Oral Health Improvement Programme: An RCT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Glasgow</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NHS Research Scotland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Glasgow</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will compare the effectiveness of Duraphat® fluoride varnish in preventing any&#xD;
      further dental decay among 3-4 year old children in nursery schools.&#xD;
&#xD;
      It is important to ascertain the additional preventive value that fluoride varnish may&#xD;
      provide when applied in conjunction with other preventive measures which form part of a&#xD;
      national dental health improvement programme targeting children at risk from dental decay.&#xD;
      1600 children will be recruited into the study for 2 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to compare the effectiveness of Duraphat® fluoride varnish&#xD;
      plus treatment as usual (TAU) with TAU only in preventing any further dental decay.&#xD;
&#xD;
      Thus the study is a clinical trial of treatment as usual (TAU) versus TAU plus fluoride&#xD;
      varnish in the nursery school setting. TAU is the core Childsmile Nursery intervention&#xD;
      (supervised daily toothbrushing with fluoride toothpaste, free dental packs of fluoride&#xD;
      toothpaste, toothbrushes and advice).&#xD;
&#xD;
      Children will be screened by asking parents whether or not the child has previously been&#xD;
      hospitalised with asthma or diagnosed with any allergies. Provided that a child has no&#xD;
      contraindications to fluoride varnish then the child can proceed to study inclusion. On the&#xD;
      day of the planned application, the dental nurse will carry out a risk assessment to reduce&#xD;
      the possibility of children with oral/facial infections being included. After excluding&#xD;
      non-eligible children, a baseline dental examination will take place, followed by&#xD;
      randomisation into treatment as usual or treatment as usual plus fluoride varnish. This&#xD;
      second group will receive up to four fluoride varnish applications at 6 month intervals.&#xD;
      After two years, all study children will be offered a final dental examination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">August 31, 2017</completion_date>
  <primary_completion_date type="Actual">August 31, 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>d3mft ( a standard measure of dental health (number of teeth where decay which has penetrated the tooth enamel, plus the number of missing or filled teeth)</measure>
    <time_frame>24 months</time_frame>
    <description>d3mft is a standard measure of dental health (number of teeth where decay which has penetrated the tooth enamel, plus the number of missing or filled teeth).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>d3mfs</measure>
    <time_frame>24 months</time_frame>
    <description>a standard measure of dental health, comprising the number of tooth surfaces where decay which has penetrated the tooth enamel, plus the number of missing or filled teeth</description>
  </secondary_outcome>
  <other_outcome>
    <measure>child oral quality of life</measure>
    <time_frame>24 months</time_frame>
    <description>quality of life using a disease specific questionnaire designed by the University College London. Cost effectiveness will be expressed as cost per quality adjusted life years (QALYs). The economic analysis will estimate the mean costs and QALYs, with standard deviations or standard errors or as mean differences with 95% confidence intervals, over two years in the first instance.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1610</enrollment>
  <condition>Dental Caries</condition>
  <arm_group>
    <arm_group_label>treatment as usual</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>any treatment from the family dentist, plus the preventive intervention programme offered to nursery school children, including daily supervised toothbrushing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Duraphat® Fluoride Varnish</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>treatment as usual (ie any treatment from the family dentist, plus the preventive intervention programme offered to nursery school children, including daily supervised toothbrushing) plus up to 4 six-monthly applications of Duraphat Fluoride Varnish in the nursery school setting.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Duraphat® Fluoride Varnish</intervention_name>
    <description>0.25 ml per application will be painted on tooth surfaces by a Childsmile trained Extended Duties Dental Nurse, currently registered with the UK General Dental Council</description>
    <arm_group_label>Duraphat® Fluoride Varnish</arm_group_label>
    <other_name>Duraphat® Fluoride Varnish (Colgate-Palmolive).</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>treatment as usual</intervention_name>
    <description>includes supervised toothbrushing, distribution of toothbrushes and toothpaste and oral health advice given at nursery school.</description>
    <arm_group_label>treatment as usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children attending nurseries which cover significant numbers of children whose home&#xD;
             postcode is within the most deprived quintile of postcodes as measured by the Scottish&#xD;
             Index of Multiple Deprivation (SIMD) (Scottish Government 2011).&#xD;
&#xD;
          -  Children in the first year of nursery school (known as the 'ante pre school year'). On&#xD;
             average the children will be three years old.&#xD;
&#xD;
          -  Every eligible child in participating nurseries will be invited to join the study,&#xD;
             irrespective of the SIMD ranking of their own postcode.&#xD;
&#xD;
          -  Children with or without pre-existing cavities, as the cavity can be treated through&#xD;
             the usual primary care dental service (i.e. as part of 'treatment as usual').&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with contraindications for the Duraphat® varnish i.e. hypersensitivity to&#xD;
             colophony and/or any other constituents, ulcerative gingivitis, stomatitis, bronchial&#xD;
             asthma, history of allergic episodes requiring hospital admission (e.g. asthma).&#xD;
&#xD;
          -  Receipt of fluoride supplements due to a small risk of fluorosis.&#xD;
&#xD;
          -  Abnormalities of the skin around the mouth, lips (e.g. cold sores) and soft tissue&#xD;
             lesions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>36 Months</minimum_age>
    <maximum_age>50 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lorna MD Macpherson</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Glasgow</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NHS Lothian</name>
      <address>
        <city>Edinburgh</city>
        <state>Scotland</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHS Greater Glasgow and Clyde</name>
      <address>
        <city>Glasgow</city>
        <state>Scotland</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHS Fife</name>
      <address>
        <city>Kirkcaldy</city>
        <state>Scotland</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHS Tayside</name>
      <address>
        <city>Perth</city>
        <state>Scotland</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>October 25, 2017</last_update_submitted>
  <last_update_submitted_qc>October 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Glasgow</investigator_affiliation>
    <investigator_full_name>Lorna Macpherson</investigator_full_name>
    <investigator_title>Professor, Glasgow Dental School</investigator_title>
  </responsible_party>
  <keyword>dental</keyword>
  <keyword>prevention</keyword>
  <keyword>caries</keyword>
  <keyword>oral</keyword>
  <keyword>children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Listerine</mesh_term>
    <mesh_term>Fluorides</mesh_term>
    <mesh_term>Fluorides, Topical</mesh_term>
    <mesh_term>Sodium fluoride topical preparation</mesh_term>
    <mesh_term>Sodium Fluoride</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01674933
org study id: GC12CO201
nct id: NCT01674933
lead sponsor: 
collaborator: 
has dmc: No
The study will compare the effectiveness of Duraphat® fluoride varnish in preventing any
      further dental decay among 3-4 year old children in nursery schools.

      It is important to ascertain the additional preventive value that fluoride varnish may
      provide when applied in conjunction with other preventive measures which form part of a
      national dental health improvement programme targeting children at risk from dental decay.
      1600 children will be recruited into the study for 2 years.
The objective of this study is to compare the effectiveness of Duraphat® fluoride varnish
      plus treatment as usual (TAU) with TAU only in preventing any further dental decay.

      Thus the study is a clinical trial of treatment as usual (TAU) versus TAU plus fluoride
      varnish in the nursery school setting. TAU is the core Childsmile Nursery intervention
      (supervised daily toothbrushing with fluoride toothpaste, free dental packs of fluoride
      toothpaste, toothbrushes and advice).

      Children will be screened by asking parents whether or not the child has previously been
      hospitalised with asthma or diagnosed with any allergies. Provided that a child has no
      contraindications to fluoride varnish then the child can proceed to study inclusion. On the
      day of the planned application, the dental nurse will carry out a risk assessment to reduce
      the possibility of children with oral/facial infections being included. After excluding
      non-eligible children, a baseline dental examination will take place, followed by
      randomisation into treatment as usual or treatment as usual plus fluoride varnish. This
      second group will receive up to four fluoride varnish applications at 6 month intervals.
      After two years, all study children will be offered a final dental examination.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: d3mft ( a standard measure of dental health (number of teeth where decay which has penetrated the tooth enamel, plus the number of missing or filled teeth)
time frame: 24 months
description: d3mft is a standard measure of dental health (number of teeth where decay which has penetrated the tooth enamel, plus the number of missing or filled teeth).
measure: d3mfs
time frame: 24 months
description: a standard measure of dental health, comprising the number of tooth surfaces where decay which has penetrated the tooth enamel, plus the number of missing or filled teeth
measure: child oral quality of life
time frame: 24 months
description: quality of life using a disease specific questionnaire designed by the University College London. Cost effectiveness will be expressed as cost per quality adjusted life years (QALYs). The economic analysis will estimate the mean costs and QALYs, with standard deviations or standard errors or as mean differences with 95% confidence intervals, over two years in the first instance.
arm group label: treatment as usual
arm group type: Active Comparator
description: any treatment from the family dentist, plus the preventive intervention programme offered to nursery school children, including daily supervised toothbrushing
arm group label: Duraphat® Fluoride Varnish
arm group type: Experimental
description: treatment as usual (ie any treatment from the family dentist, plus the preventive intervention programme offered to nursery school children, including daily supervised toothbrushing) plus up to 4 six-monthly applications of Duraphat Fluoride Varnish in the nursery school setting.
intervention type: Drug
intervention name: Duraphat® Fluoride Varnish
description: 0.25 ml per application will be painted on tooth surfaces by a Childsmile trained Extended Duties Dental Nurse, currently registered with the UK General Dental Council
arm group label: Duraphat® Fluoride Varnish
other name: Duraphat® Fluoride Varnish (Colgate-Palmolive).
intervention type: Behavioral
intervention name: treatment as usual
description: includes supervised toothbrushing, distribution of toothbrushes and toothpaste and oral health advice given at nursery school.
arm group label: treatment as usual
criteria: 
gender: All
minimum age: 36 Months
maximum age: 50 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Lorna MD Macpherson
role: Principal Investigator
affiliation: University of Glasgow
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Glasgow
investigator full name: Lorna Macpherson
investigator title: Professor, Glasgow Dental School
mesh term: Dental Caries
mesh term: Listerine
mesh term: Fluorides
mesh term: Fluorides, Topical
mesh term: Sodium fluoride topical preparation
mesh term: Sodium Fluoride