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NCT Number: NCT07359937

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

multicomponent intervention

Behavioral
  • 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)

Conventional intervention

Behavioral

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

Primary outcomes

  1. Urinary fluoride concentrations

    Time frame: Time Frame: Baseline, 3 , 6, and 12 months.

    Decrease in urinary fluoride concentrations in children

Secondary outcomes

  1. Knowledge, attitudes, and practices (KAP)

    Time frame: 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.

  2. Fluoride concentrations in water

    Time frame: Time Frame: baseline, 3, 6, and 12 months

    Reduction in fluoride concentrations in water.

Sponsors and collaborators

Lead sponsor

Universidad Antonio Nariño

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 22, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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