Fluoride Varnish For Childsmile Nursery School Attenders (PT@3)

October 25, 2017 updated by: Lorna Macpherson, University of Glasgow

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

1610

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Scotland
      • Edinburgh, Scotland, United Kingdom
        • NHS Lothian
      • Glasgow, Scotland, United Kingdom
        • NHS Greater Glasgow and Clyde
      • Kirkcaldy, Scotland, United Kingdom
        • NHS FIFE
      • Perth, Scotland, United Kingdom
        • NHS Tayside

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children attending nurseries which cover significant numbers of children whose home postcode is within the most deprived quintile of postcodes as measured by the Scottish Index of Multiple Deprivation (SIMD) (Scottish Government 2011).
  • Children in the first year of nursery school (known as the 'ante pre school year'). On average the children will be three years old.
  • Every eligible child in participating nurseries will be invited to join the study, irrespective of the SIMD ranking of their own postcode.
  • Children with or without pre-existing cavities, as the cavity can be treated through the usual primary care dental service (i.e. as part of 'treatment as usual').

Exclusion Criteria:

  • Children with contraindications for the Duraphat® varnish i.e. hypersensitivity to colophony and/or any other constituents, ulcerative gingivitis, stomatitis, bronchial asthma, history of allergic episodes requiring hospital admission (e.g. asthma).
  • Receipt of fluoride supplements due to a small risk of fluorosis.
  • Abnormalities of the skin around the mouth, lips (e.g. cold sores) and soft tissue lesions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: treatment as usual
any treatment from the family dentist, plus the preventive intervention programme offered to nursery school children, including daily supervised toothbrushing
Behavioral: treatment as usual
includes supervised toothbrushing, distribution of toothbrushes and toothpaste and oral health advice given at nursery school.
Experimental: Duraphat® Fluoride Varnish
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.
Drug: Duraphat® Fluoride Varnish
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
Other Names:
  • Duraphat® Fluoride Varnish (Colgate-Palmolive).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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).
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
d3mfs
Time Frame: 24 months
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
24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
child oral quality of life
Time Frame: 24 months
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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Glasgow

Collaborators

NHS Research Scotland

Investigators

  • Principal Investigator: Lorna MD Macpherson, University of Glasgow

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

August 31, 2017

Study Completion (Actual)

August 31, 2017

Study Registration Dates

First Submitted

August 24, 2012

First Submitted That Met QC Criteria

August 28, 2012

First Posted (Estimate)

August 29, 2012

Study Record Updates

Last Update Posted (Actual)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 25, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC12CO201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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