NCT07359937

Design of a Multicomponent Intervention to Reduce the Risk of Exposure Fluorine

ENROLLING BY INVITATION NA Last updated 22 January 2026

What this trial tests

NA trial testing multicomponent intervention in Fluorosis, Dental in 90 participants. Enrolling by invitation.

Timeline

1 August 2025

Primary endpoint
6 August 2026

30 June 2027

Quick facts

Lead sponsor	Universidad Antonio Nariño
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	90
Start date	1 August 2025
Primary completion	6 August 2026
Estimated completion	30 June 2027
Sites	1 location across Colombia

Drugs / interventions tested

• multicomponent intervention
• Conventional intervention

Conditions studied

• Fluorosis, Dental — all drugs for Fluorosis, Dental →
• Fluorosis — all drugs for Fluorosis →

Sponsor

Universidad Antonio Nariño

Who can join

Adults 2 to 5, any sex, with Fluorosis, Dental or Fluorosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction Systemic exposure to fluoride is a significant challenge for global public health; this is because although fluoride prevents dental caries, prolonged exposure to high concentrations can cause adverse effects on various organs and systems, especially the teeth. Despite the existence of preventive strategies to reduce this exposure, evidence on the effectiveness of multicomponent interventions is limited. This protocol describes the design of a randomized controlled trial to evaluate the effects of a multicomponent intervention on parents and children to reduce the risk of exposure to high concentrations of fluoride in children. Methods This is a randomized controlled trial, and kindergartens in the municipalities of the Department of Huila, Colombia, will be recruited. The intervention group will receive a comprehensive five-component program: installation of water filters to reduce fluoride consumption; educational sessions for parents and children to raise awareness and promote healthy practices; outreach activities to strengthen collective knowledge; and a maintenance phase to ensure the program's sustainability. In contrast, the control group will participate in a conventional educational strategy focused on the parent-child dyad. Measurements will be taken at four points in time: pre-intervention for baseline and post-intervention at 3, 6, and 12 months. The evaluation of results includes the concentration of fluoride in children's urine, fluoride levels in water (to validate the effectiveness of filtration), and changes in parents' knowledge, attitudes, and practices. Discussion The trial will evaluate the effectiveness of a multicomponent intervention aimed at parents and children to reduce the risk of fluoride exposure. Through integrative methodological approaches and objective measurements, it will demonstrate significant improvements in reducing fluoride exposure in children and in parents' knowledge, attitudes, and practices. It will contribute to child health programs, strengthen preventive oral health strategies with an impact on public policy, community health, and new lines of research on fluoride.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.