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A cluster randomised control trial to measure the benefit of fluoride varnish in preventing dental decay when applied to the permanent teeth of children for three years in the school setting - Fluoride varnish to prevent dental decay in young children

A cluster randomised control trial to measure the benefit of fluoride varnish in preventing dental decay when applied to the permanent teeth of children for three years in the school setting - Fluoride varnish to prevent dental decay in young children

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-003845-15-GB
Enrollment
6800
Registered
2005-09-15
Start date
2005-12-13
Completion date
Unknown
Last updated
2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental caries in first permanent molars

Interventions

Trade Name: Colgate Duraphat 5% Sodium Fluoride Varnish Product Name: Duraphat Product Code: Duraphat Pharmaceutical Form: Dental suspension

Sponsors

University of Manchester
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All Children in state maintained schools aged 7-8 years(at baseline) in Burnley, Pendle and Rossendale, Blackburn with Darwen and Hyndburn and Ribble Valley PCTs whose parents consent to their participation will be included. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Excluded children will be those whose parents do not consent to their participation, or have serious allergies including asthma.

Design outcomes

Primary

MeasureTime frame
Secondary Objective: ;Main Objective: To determine if fluoride varnish (Duraphat) applied in the school setting 3 times a year for 3 years to the biting surfaces of the permanent back teeth of children aged 6-8 years at the start of the study, leads to reduced levels of dental decay in the permanent back teeth when compared with a control group receiving no Duraphat.; Primary end point(s): It is the last dental examination of the last subject included in the study.

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026