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

January 13, 2026 updated by: Universidad Antonio Nariño

Design of a Multicomponent Intervention to Reduce the Risk of Exposure to High Concentrations of Fluoride in Children in Huila, Colombia

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Neiva, Colombia
        • Claudia García-Rojas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Kindergartens located in municipalities with exposure to fluoride concentrations in water.
  • Have a school feeding program.
  • The child must be enrolled.
  • They must be registered in the school feeding program.
  • The primary caregiver must be able to read.
  • The caregiver must agree to participate voluntarily and sign the informed consent form.
  • The caregiver must commit to attending all components of the intervention (education and collection of the child's urine sample).

Exclusion Criteria:

  • Parents or children with conditions or situations that may interfere with the assimilation of the components of the strategy.
  • Children who wear diapers will be excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Side
Behavioral: multicomponent intervention
  1. Installation of physical barriers: a reverse osmosis water filter.
  2. Educational sessions for parents: three thematic modules.
  3. Educational sessions for children: one thematic modules.
  4. Outreach activities: To ensure the sustainability of the intervention.
  5. Maintenance phase: The population will have free access to educational resources through the "Camaleón Sonriente cuida tus dientes" (Smiling Chameleon Takes Care of Your Teeth)
Active Comparator: Control side
Behavioral: Conventional intervention
The intervention will include training on the cariogenic diet, flossing, and hand washing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary fluoride concentrations.
Time Frame: Baseline, 3 , 6, and 12 months.
Decrease in urinary fluoride concentrations in children.
Baseline, 3 , 6, and 12 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge, attitudes, and practices (KAP).
Time Frame: Baseline, 3 , 6 and 12 months.
To assess changes in parents' knowledge and attitudes, the Knowledge, Attitudes, and Practices (KAP) survey will be administered, after validation. The instrument was designed for this purpose, taking into account the components of the intervention. The knowledge section consists of 12 items and explores parents' understanding of natural and non-natural sources of fluoride and its effects on oral and systemic health. The attitudes section consists of 10 items and identifies perceptions, beliefs, motivations, and willingness to act in response to fluoride risk, water quality, willingness to change habits, and dental follow-ups. The practices section, with 9 items, addresses information on current behaviors related to consulting fluoride content, modifying water sources, dental care, and supervision in the use of dental products. Each section of the instrument includes ordinal scale variables and provides an overall score that allows each section to be classified as good, fair, or poor.
Baseline, 3 , 6 and 12 months.
fluoride concentrations in water.
Time Frame: baseline, 3, 6, and 12 months.
Reduction in fluoride concentrations in water.
baseline, 3, 6, and 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Antonio Nariño

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2025

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

August 29, 2027

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

November 15, 2025

First Posted (Estimated)

November 18, 2025

Study Record Updates

Last Update Posted (Actual)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UAN-Fluoride

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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