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Prospective Randomized trial of the effectiveness of 25 % xylitol toothpaste in prevention of severe carious lesions of Kosovar infants

Prospective Randomized trial of the effectiveness of 25 % xylitol toothpaste in prevention of severe carious lesions of Kosovar infants - Xylitol toothpaste in caries prevention

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00024367
Enrollment
520
Registered
2021-02-09
Start date
2013-09-02
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

K02

Interventions

Group 1: arm 1: test group to this group the Xylitol toothpaste was given and it was required from their parents to brush child tooth with this toothpaste twice a day. Also they had to come in a visit

Sponsors

Pediatric Dentist, Univeristy Dental Clinical Center of Kosovo
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Months to 11 Months

Inclusion criteria

Inclusion criteria: Initially, dyads were selected if children had no systemic disease, children were not older than 12 months and if mother were cooperative and gave approval to participate voluntary.

Exclusion criteria

Exclusion criteria: The exclusion maternal criteria were receiving chemotherapy or radiotherapy, having a cognitive or physical handicap or having a child being over 12 months of age.

Design outcomes

Primary

MeasureTime frame
Primary outcome was a comparison of caries prevalence (defined at d3-6 level) in test and control groups. The net proportion difference for the d3-6mfs ?0 prevalence is 32.2 % with control group having a prevalence of 49.5 % versus a test group, of 13.7 %.

Secondary

MeasureTime frame
Secondary outcome considered the comparison of groups in term of caries experiences at enamel breakdown level. The mean d3-6mfs of control group children was 3.8 (±5.9) and for the test group children 0.73: the preventive fraction based on these estimations, was 81.0 %.

Countries

Kosovo

Contacts

Public ContactBlerta Latifi-Xhemajli

Pediatric Dentist, Univeristy Dental Clinical Center of Kosovo

blerta.latifi@uni-pr.edu+38344129732

Outcome results

None listed

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