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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2012 by University of Glasgow
Sponsor:
Collaborator:
NHS Scotland
Information provided by (Responsible Party):
Lorna Macpherson, University of Glasgow
ClinicalTrials.gov Identifier:
NCT01674933
First received: August 24, 2012
Last updated: August 28, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Dental Caries
Drug: Duraphat® Fluoride Varnish
Behavioral: treatment as usual
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Glasgow:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • d3mfs [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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:
  • child oral quality of life [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1610
Study Start Date: October 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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 FV applications at 6 month intervals. After two years, all study children will be offered a final dental examination.

  Eligibility

Ages Eligible for Study:   36 Months to 47 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01674933

Contacts
Contact: Styephen Turner, MSc 00441315364997 s.turner@dundee.ac.uk

Locations
United Kingdom
NHS Lothian Not yet recruiting
Edinburgh, Scotland, United Kingdom
NHS Greater Glasgow and Clyde Not yet recruiting
Glasgow, Scotland, United Kingdom
Sponsors and Collaborators
University of Glasgow
NHS Scotland
Investigators
Principal Investigator: Lorna MD Macpherson University of Glasgow
  More Information

No publications provided

Responsible Party: Lorna Macpherson, Professor, Glasgow Dental School, University of Glasgow
ClinicalTrials.gov Identifier: NCT01674933     History of Changes
Other Study ID Numbers: GC12CO201
Study First Received: August 24, 2012
Last Updated: August 28, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by University of Glasgow:
dental
prevention
caries
oral
children

Additional relevant MeSH terms:
Dental Caries
Stomatognathic Diseases
Tooth Demineralization
Tooth Diseases
Fluorides
Listerine
Sodium Fluoride
Anti-Infective Agents
Anti-Infective Agents, Local
Cariostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014