Fluoride Varnish For Childsmile Nursery School Attenders (PT@3)
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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 |
- 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).
- 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
- 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: | August 2017 |
| Estimated Primary Completion Date: | March 2017 (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 fluoride varnish 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 50 Months (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01674933
| United Kingdom | |
| 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 | |
| Principal Investigator: | Lorna MD Macpherson | University of Glasgow |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | June 3, 2016 |
| 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 Tooth Demineralization Tooth Diseases Stomatognathic Diseases Fluorides Fluorides, Topical Sodium fluoride topical preparation |
Sodium Fluoride Listerine Cariostatic Agents Protective Agents Physiological Effects of Drugs Anti-Infective Agents, Local Anti-Infective Agents |
ClinicalTrials.gov processed this record on September 30, 2016