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

Not Applicable

• Conditions: K02; Dental caries

• Registration Number: DRKS00024367
• Lead Sponsor: Pediatric Dentist, Univeristy Dental Clinical Center of Kosovo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-10-07
• Study Start: 2021-02-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 520

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

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 %.