Fluoride Varnish For Childsmile Nursery School Attenders
NCT ID: NCT01674933
Last Updated: 2017-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1610 participants
INTERVENTIONAL
2012-10-31
2017-08-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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treatment as usual
any treatment from the family dentist, plus the preventive intervention programme offered to nursery school children, including daily supervised toothbrushing
treatment as usual
includes supervised toothbrushing, distribution of toothbrushes and toothpaste and oral health advice given at nursery school.
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.
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
Interventions
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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
treatment as usual
includes supervised toothbrushing, distribution of toothbrushes and toothpaste and oral health advice given at nursery school.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
36 Months
50 Months
ALL
Yes
Sponsors
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NHS Research Scotland
OTHER
University of Glasgow
OTHER
Responsible Party
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Lorna Macpherson
Professor, Glasgow Dental School
Principal Investigators
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Lorna MD Macpherson
Role: PRINCIPAL_INVESTIGATOR
University of Glasgow
Locations
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NHS Lothian
Edinburgh, Scotland, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, Scotland, United Kingdom
NHS Fife
Kirkcaldy, Scotland, United Kingdom
NHS Tayside
Perth, Scotland, United Kingdom
Countries
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References
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Wright W, Turner S, Anopa Y, McIntosh E, Wu O, Conway DI, Macpherson LM, McMahon AD. Comparison of the caries-protective effect of fluoride varnish with treatment as usual in nursery school attendees receiving preventive oral health support through the Childsmile oral health improvement programme - the Protecting Teeth@3 Study: a randomised controlled trial. BMC Oral Health. 2015 Dec 18;15:160. doi: 10.1186/s12903-015-0146-z.
Other Identifiers
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GC12CO201
Identifier Type: -
Identifier Source: org_study_id