Fluoride Varnish For Childsmile Nursery School Attenders (PT@3)
|ClinicalTrials.gov Identifier: NCT01674933|
Recruitment Status : Completed
First Posted : August 29, 2012
Last Update Posted : October 26, 2017
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 or disease||Intervention/treatment||Phase|
|Dental Caries||Drug: Duraphat® Fluoride Varnish Behavioral: treatment as usual||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1610 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||October 2012|
|Primary Completion Date :||August 31, 2017|
|Study Completion Date :||August 31, 2017|
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).
- 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 ]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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01674933
|Edinburgh, Scotland, United Kingdom|
|NHS Greater Glasgow and Clyde|
|Glasgow, Scotland, United Kingdom|
|Kirkcaldy, Scotland, United Kingdom|
|Perth, Scotland, United Kingdom|
|Principal Investigator:||Lorna MD Macpherson||University of Glasgow|