Improved dental health for remote Aboriginal children: a cluster randomised trial.

Not Applicable

Completed

• Conditions: Early childhood caries; Public Health - Epidemiology; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12609001000291
• Lead Sponsor: Menzies School of Health Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-11-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

Aboriginal
Aged 18m to 4y
Living in a remote community
Able to attend clinic for regular follow up

Exclusion Criteria

Allergy to fluoride varnish
Receiving treatment for asthma
Congenital dental disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Caries increment (rate of new caries) assessed by dental examination.[2 years from baseline.]

Secondary Outcome Measures

Name	Time	Method
Caries increment (with adjustment of potential confounders) assessed by dental examination.[2 years from baseline.];Gingivitis assessed by dental examination.[2 years from baseline.];Dental abscess assessed by dental examination.[2 years from baseline.];The proportion of children undergoing a dental procedure (including fluoride varnish application) by dentist or dental therapist assessed by dental examination and review of medical records.[2 years from baseline.];Behavioural change as reported by parents in questionnaires completed at baseline and at 2 year follow up.[2 years from baseline.];Adverse events- any reaction to fluoride varnish requiring medical review. Reactions resulting in admission to hospital or considered life-threatening will be reported as serious adverse events. These will be assessed by review of medical records.[2 years from baseline.]