Fluoride Varnish For Childsmile Nursery School Attenders

Dental Caries Clinical Trial

— PT@3  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01674933
• Other study ID #: GC12CO201
• Status: Completed
• Phase: Phase 4
• First received: August 24, 2012
• Last updated: October 25, 2017
• Start date: October 2012
• Est. completion date: August 31, 2017

Study information

• Verified date: October 2017
• Source: University of Glasgow
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1610
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 36 Months to 50 Months

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries

Intervention

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

Behavioral:
• treatment as usual
includes supervised toothbrushing, distribution of toothbrushes and toothpaste and oral health advice given at nursery school.

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
University of Glasgow	NHS Scotland

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	child oral quality of life	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
Primary	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)	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	d3mfs	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