Effectiveness of fluoride varnish in preventing caries on primary dentition: A 2 year follow-up randomized controlled clinical trial

Effectiveness of fluoride varnish in preventing caries on primary dentition: A 2 year follow-up randomized controlled clinical trial - Prevention of caries in young children

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00013980

Enrollment

500

Registered

2018-02-05

Start date

2013-12-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

caries prevention

Interventions

Group 1: Fluoride varnish was applied on the children teeth four times a year at intervals every three months, for too years Group 2: Control group: After the parents were informed about the nature a

Eligibility

Sex/Gender

All

Age

8 Months to 29 Months

Inclusion criteria

Inclusion criteria: incusion criteria were the age of children and consent form given from the parents that their child can participate in the study

Exclusion criteria

Exclusion criteria: exclusion criteria were the age of children and consent form not given from the parents that their child can participate in the study

Design outcomes

Primary

Measure	Time frame
In the base year of the study, after examining the 504 children, caries free(dmfts=0) were 403 children (80.0%). Mean dmfs according to the ICDAS- index, was 1.1 ± 2.9. After abstention of 77 children (15%) at the end of the study, the total number of examined subjects was 427. Caries free were 240 children (56.2%) and mean dmfs was 7.6±11.9. The period between the two phases of examination, characterized by significant statistical difference in the prevalence and the mean dmfs (p 0.001). After applying the F-varnish four times a year for 24 months, we have found a significant difference (p-0.0001) of dmfs-index between test (dmfs = 5.2 (10.5) and the control group (dmfs = 10.1 (12.9)	—

Measure

Time frame

In the base year of the study, after examining the 504 children, caries free(dmfts=0) were 403 children (80.0%). Mean dmfs according to the ICDAS- index, was 1.1 ± 2.9. After abstention of 77 children (15%) at the end of the study, the total number of examined subjects was 427. Caries free were 240 children (56.2%) and mean dmfs was 7.6±11.9. The period between the two phases of examination, characterized by significant statistical difference in the prevalence and the mean dmfs (p 0.001). After applying the F-varnish four times a year for 24 months, we have found a significant difference (p-0.0001) of dmfs-index between test (dmfs = 5.2 (10.5) and the control group (dmfs = 10.1 (12.9)

—

Secondary

Measure	Time frame
Fluoride varnish applications every three months, in a period for 2 years, also had a impact in several clinical issues: prevalence, experience and severity reductions. The reduction of caries was evaluated after the dental status of caries was recorded at the endpoint of the study. Dental status was recorded through the “International Caries Detection and Assessment System” (ICADS)-index	—

Contacts

Public ContactBlerta Latifi-Xhemajli

Pediatric Dentist, University Dental Clinical Center of Kosovo

blerta.latifi@uni-pr.edu+37744129732

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 20, 2026