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The effect of MI Varnish™ on the development of tooth decay in 6- and 12-year-old children in Riga, Latvia

The effect of MI Varnish™ on dental caries among 6- and 12-year-old children in Riga, Latvia. A 3-year study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10584414
Enrollment
128
Registered
2022-03-07
Start date
2016-02-01
Completion date
Unknown
Last updated
2023-08-28

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

Conditions

Dental caries development Oral Health

Interventions

Current interventions, as of 04/04/2022: All children were recruited into the study during their regular dental check-ups in a random manner as follows. During the visit, children are listed in seri
12 years old into group 3), while even numbers were recruited into the control groups (6 years old into group 2
12 years old into group 4). Following the baseline caries examination, the treatment groups (groups 1 & 3) received the application of MI Varnish™ (5% sodium fluoride GC Corp., Tokyo, Japan), while
Dentsply Caulk, Germany) and then MI Varnish™ (GC Corp., Tokyo, Japan) was reapplied on all too

Sponsors

Riga Stradinš University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Healthy volunteers at the age of 6 and 12 years, living in Riga.

Exclusion criteria

Exclusion criteria: 1. Children and/or their parents refused to participate in the study 2. The families moved away from Riga 3. Children or parents did not answer the 3 telephone calls confirming their appointments 4. Orthodontic braces 5. General ill-health within the study period

Design outcomes

Primary

MeasureTime frame
Current primary outcome measure as of 04/04/2022: Measured at baseline and 36 months: 1. Caries increment measured using the caries assessment criteria of the ICDAS II (https://www.iccms-web.com) 2. Oral hygiene indices measured using the Green-Vermillion oral hygiene index (G-V index) 3. Dietary habits measured using a questionnaire for children and/or their parents about snacking habit, intake of chocolates, carbonated soft or sport drinks during the day, number of tea spoons of sugar (t.s.) per cup of tea, and the number of cups of tea consumed daily _____ Previous primary outcome measure: Measured at baseline and every 3 months for 36 months: 1. Caries increment measured using the caries assessment criteria of the ICDAS II and digital bitewing (BW) X-rays 2. Oral hygiene indices measured using the Green-Vermillion oral hygiene index (G-V index) 3. Dietary habits measured using a questionnaire for children and/or their parents about snacking habit, intake of chocolates, carbonated soft or sport drinks during the day, number of tea spoons of sugar (t.s.) per cup of tea, and the number of cups of tea consumed daily

Secondary

MeasureTime frame
There are no secondary outcome measures

Countries

Latvia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 12, 2026