The online version of this article (doi:10.1186/s12903-015-0146-z) contains supplementary material, which is available to authorized users.
The study is funded by the Scottish Government who also provide funds for Childsmile, the University of Glasgow, the Childsmile Central Evaluation & Research Team and the Health Boards for the Childsmile Programme.
AM wrote the first draft of the protocol. All authors contributed to the development of the protocol through its various amendments. BW, ST and DC are responsible for study coordination, LM is the Chief Investigator, and AM is the study statistician. YA, OW and EM designed the economic evaluation. ST was responsible for obtaining ethical approval for the trial. All authors contributed to the writing of the manuscript and read and approved the final version of the manuscript.
The Scottish Government set out its policy on addressing the poor oral health of Scottish children in 2005. This led to the establishment of Childsmile, a national programme designed to improve the oral health of children in Scotland. One element of the programme promotes daily tooth brushing in all nurseries in Scotland (Childsmile Core). A second targeted component (Childsmile Nursery) offers twice-yearly application of fluoride varnish to children attending nurseries in deprived areas. Studies suggest that fluoride varnish application can reduce caries in both adult and child populations. This trial aims to explore the effectiveness and cost-effectiveness of additional preventive value fluoride varnish application compared to Childsmile Core.
The Protecting Teeth@3 Study is an ongoing 2 year parallel group randomised treatment as usual controlled trial. Three-year-old children attending the ante pre-school year are randomised (1:1) to the intervention arm (fluoride varnish & treatment as usual) or the control arm (treatment as usual). Children in the intervention arm will have Duraphat® fluoride varnish painted on the primary tooth surfaces and will continue to receive treatment as usual: the core Childsmile Nursery intervention. Children in the treatment as usual arm will receive the same series of contacts, without the application of varnish and will also continue with the Childsmile Core intervention. Interventions are undertaken by Childsmile trained extended duty dental nurses at six-monthly intervals. Participants receive a baseline dental inspection in nursery and an endpoint inspection in Primary 1 at the age of 5 years old.
We will use primary and secondary outcome measures to compare the effectiveness of Duraphat® fluoride varnish plus treatment as usual with treatment as usual only in preventing any further dental decay. We will also undertake a full economic evaluation of the trial.
This study is registered at ClinicalTrials.gov. Number: NCT01674933 (24 August 2012).
Additional file 1: MHRA Notification of trial. (PDF 53 kb)12903_2015_146_MOESM1_ESM.pdf
Additional file 2: CHU9D questionnaire – Nursery version. (DOCX 79 kb)12903_2015_146_MOESM2_ESM.docx
Additional file 3: PedsQL questionnaire – Nursery version. (DOCX 129 kb)12903_2015_146_MOESM3_ESM.docx
Additional file 4: SOHO-5 questionnaire. (DOCX 48 kb)12903_2015_146_MOESM4_ESM.docx
Additional file 5: Child’s use of health and dental care services questionnaire. (DOCX 20 kb)12903_2015_146_MOESM5_ESM.docx
Additional file 6: Subjective global transition judgement questions. (DOCX 24 kb)12903_2015_146_MOESM6_ESM.docx
Additional file 7: Questionnaire Cover Sheet – Round 1. (DOCX 27 kb)12903_2015_146_MOESM7_ESM.docx
Additional file 8: Flowchart for Assessing and Reporting Adverse Reactions. (DOCX 38 kb)12903_2015_146_MOESM8_ESM.docx
Additional file 9: Trial staff costs questionnaire. (DOCX 445 kb)12903_2015_146_MOESM9_ESM.docx
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- 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
David I. Conway
Lorna M. D. Macpherson
Alex D. McMahon
- BioMed Central
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