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Preventive Effect of Salt Fluoridation

NCT02585882 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 441

Last updated 2015-10-26

No results posted yet for this study

Summary

This was a block-randomized, controlled, open-label trial and was executed in two preschools in The Gambia. Fluoridated table salt (250 mg F/kg salt) was administered in daily communal preschool feeding. In total, 304 children in the test group and 137 children in the control group, aged 3 to 5 years were enrolled according to inclusion criteria (complete primary dentition and a parental or legal guardian informed consent). Mean difference of incidence of cavitated carious lesions (Δd3/4mft) after 12 months was the primary end point. The relative preventive dental caries effect was. Secondary end points were the difference of incidence of white spot lesions and the difference of incidence of total carious lesions.

Conditions

  • Fluorides, Dental Caries

Interventions

OTHER

Fluoride table salt

Sponsors & Collaborators

  • University of Witten/Herdecke

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-08-31
Completion
2015-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02585882 on ClinicalTrials.gov