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Fluoride Varnish For Childsmile Nursery School Attenders

NCT01674933 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1610

Last updated 2017-10-26

No results posted yet for this study

Summary

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.

Conditions

  • Dental Caries

Interventions

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

BEHAVIORAL

treatment as usual

includes supervised toothbrushing, distribution of toothbrushes and toothpaste and oral health advice given at nursery school.

Sponsors & Collaborators

  • NHS Research Scotland

    collaborator OTHER

  • University of Glasgow

    lead OTHER

Principal Investigators

  • Lorna MD Macpherson · University of Glasgow

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
36 Months
Max Age
50 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01674933 on ClinicalTrials.gov