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Effect of fluoride varnish with and without calcium phosphate on dental caries prevention in preschool children: a randomized control trial

Effect of fluoride varnish with and without calcium phosphate on dental caries prevention in preschool children: a randomized control trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20180527003
Enrollment
Unknown
Registered
2018-05-27
Start date
2018-06-12
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

healthy preschool children with active dental caries Fluoride varnish Dental Caries Calcium Phosphate Preschool children Prevention

Interventions

Fluoride varnish without calcium phosphate (Duraphat) is 5% sodium fluoride apply active dental caries in children,Fluoride varnish with calcium phosphate (Embrace) is 5% sodium fluoride with calcium
Active Comparator Other,Active Comparator Other
Fluoride varnish without calcium phosphate (Duraphat),Fluoride varnish with calcium phosphate (Embrace)

Sponsors

Faculty of dentistry, Khon Kaen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Months to 3 Years

Inclusion criteria

Inclusion criteria: -Children under 3 years of age -Children who have active white spot lesion or enamel caries at least one tooth

Exclusion criteria

Exclusion criteria: -Children who have allergy on extract pine tree and colophonium -Children who have tooth anomaly and structure deficiency -Children who will not reside in Amphur Muang, Khon Kaen on the following one year and who plan to migrate away from Khon Kaen during the study time -Primary careers are who unable to response to questionnaire -Children who have medical condition that will affect the treatment eg. severe asthma -Children who have received fluoride varnish not over 3 months

Design outcomes

Primary

MeasureTime frame
Caries increment 12 months The mean difference dmfs from baseline, 6 months and 12 months,Caries increment 12 months The mean difference dmfs from baseline, 6 months and 12 months

Secondary

MeasureTime frame
transition of caries lesion 12 months The difference ICDAS score from baseline, 6 months and 12 months follow up

Countries

Thailand

Contacts

Public ContactOnauma Angwaravong

Faculty of Dentistry, Khon Kaen University

onaang@kku.ac.th043202405

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026