Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT01674933
Eligibility 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
36 Months
Maximum Age:
50 Months
Study:
NCT01674933
Study Brief:
Protocol Section:
NCT01674933