Comparison of the caries-protective effect of fluoride varnish (Duraphat®) with treatment as usual in nursery school attenders receiving preventive oral health support through the Childsmile Programme: a Randomised Controlled Trial - Fluoride varnish for Childsmile nursery school attenders: an RCT

Greater Glasgow and Clyde NHS Board0 个研究点目标入组 1,284 人开始时间: 2012年10月25日最近更新: 2020年7月27日

适应症

试验速览

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•1. Attendance at a Local Authority nursery school or class as a ante pre-school attendee (entry after third birthday).
•2. Participating nurseries will serve significant numbers of children whose home postcode is within the most deprived quintile of postcodes as measured by the Scottish Index of Multiple Deprivation. Every eligible child in participating nurseries will be invited to join the study, irrespective of the SIMD ranking of their own postcode.
•3. Children with or without pre-existing cavities are included, as the cavity can be treated through the usual primary care dental service (ie as part of ‘treatment as usual’).
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 1610
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•Children with contraindications for Duraphat varnish i.e.
•hypersensitivity to colophony and/or any other constituents,
•ulcerative gingivitis,
•stomatitis,
•bronchial asthma,
•history of allergic episodes requiring hospital admission (eg for asthma).
•2. Receipt of fluoride supplements, due to a small risk of fluorosis.
•3. Abnormalities of the skin around the mouth, lips (e.g. cold sores) and soft tissue lesions.

发起方

Greater Glasgow and Clyde NHS Board