Fluoride Varnish For Childsmile Nursery School Attenders
PT@3
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
1 other identifier
interventional
1,610
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2012
Longer than P75 for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2012
CompletedFirst Posted
Study publicly available on registry
August 29, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2017
CompletedOctober 26, 2017
October 1, 2017
4.9 years
August 24, 2012
October 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (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)
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 Outcomes (1)
d3mfs
24 months
Other Outcomes (1)
child oral quality of life
24 months
Study Arms (2)
treatment as usual
ACTIVE COMPARATORany treatment from the family dentist, plus the preventive intervention programme offered to nursery school children, including daily supervised toothbrushing
Duraphat® Fluoride Varnish
EXPERIMENTALtreatment 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.
Interventions
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
includes supervised toothbrushing, distribution of toothbrushes and toothpaste and oral health advice given at nursery school.
Eligibility Criteria
You may qualify if:
- 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').
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Glasgowlead
- NHS Research Scotlandcollaborator
Study Sites (4)
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
Related Publications (1)
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.
PMID: 26681191DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lorna MD Macpherson
University of Glasgow
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Glasgow Dental School
Study Record Dates
First Submitted
August 24, 2012
First Posted
August 29, 2012
Study Start
October 1, 2012
Primary Completion
August 31, 2017
Study Completion
August 31, 2017
Last Updated
October 26, 2017
Record last verified: 2017-10