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

NCT07232888 | Active Not Recruiting

• 1 other identifier: UAN-Fluoride
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fluorosis, Dental; Fluorosis

Keywords

Fluorine; Fluorides; Enamel fluorosis; Primary prevention; Health education

Outcome Measures

Primary Outcomes (1)

• Urinary fluoride concentrations.

  Decrease in urinary fluoride concentrations in children.

  Baseline, 3 , 6, and 12 months.

Secondary Outcomes (2)

• Knowledge, attitudes, and practices (KAP).

  Baseline, 3 , 6 and 12 months.

• fluoride concentrations in water.

  baseline, 3, 6, and 12 months.

Study Arms (2)

Experimental Side

EXPERIMENTAL

Behavioral: multicomponent intervention

Control side

ACTIVE COMPARATOR

Behavioral: Conventional intervention

Interventions

multicomponent intervention BEHAVIORAL

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)

Experimental Side

Conventional intervention BEHAVIORAL

The intervention will include training on the cariogenic diet, flossing, and hand washing.

Control side

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Antonio Nariño: lead

Study Sites (1)

Claudia García-Rojas

Neiva, Colombia

Location

MeSH Terms

Conditions

Fluorosis, Dental; Fluoride Poisoning; Health Education

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Poisoning; Chemically-Induced Disorders; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 18, 2025
• Study Start: May 2, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): August 29, 2027
• Last Updated: January 14, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)