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

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Dental Caries	Drug: Duraphat® Fluoride Varnish; Behavioral: treatment as usual	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	1610 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
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
Study Start Date :	October 2012
Actual Primary Completion Date :	August 31, 2017
Actual Study Completion Date :	August 31, 2017

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: Duraphat® Fluoride Varnish (Colgate-Palmolive).

Outcome Measures

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Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

1. 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

Other Outcome Measures:

1. 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.

Eligibility Criteria

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Ages Eligible for Study:	36 Months to 50 Months (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United Kingdom
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

Sponsors and Collaborators

University of Glasgow

NHS Scotland

Investigators

Principal Investigator:	Lorna MD Macpherson	University of Glasgow

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Lorna Macpherson, Professor, Glasgow Dental School, University of Glasgow
ClinicalTrials.gov Identifier:	NCT01674933 History of Changes
Other Study ID Numbers:	GC12CO201
First Posted:	August 29, 2012
Last Update Posted:	October 26, 2017
Last Verified:	October 2017

Keywords provided by Lorna Macpherson, University of Glasgow:

dental; prevention; caries; oral; children

Additional relevant MeSH terms:

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Fluorides; Fluorides, Topical; Sodium fluoride topical preparation	Sodium Fluoride; Listerine; Cariostatic Agents; Protective Agents; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents