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 represents a significant challenge for global public health. Although it prevents dental caries, prolonged high concentrations affect organs and systems, especially teeth. Despite preventive strategies, evidence of their effectiveness is limited. This protocol describes a randomized controlled trial to evaluate a multicomponent intervention in parents and children that reduces the risk of exposure to high concentrations of fluoride in children. METHODS: Randomized trial in kindergartens in municipalities in the Department of Huila, Colombia. The intervention group will receive a five-component program: installation of water filters to reduce fluoride consumption; educational sessions for parents and children to promote awareness and healthy practices; outreach activities to strengthen collective knowledge; and a maintenance phase for sustainability. The control group will participate in a conventional educational strategy on cariogenic diet, flossing, and hand washing, focused on the parent-child dyad. Measurements will be taken at four points in time: baseline (pre-intervention) and post-intervention at 3, 6, and 12 months. The evaluation will include fluoride concentration in children's urine, levels in water (filter validation), and changes in parental knowledge, attitudes, and practices. DISCUSSION: The trial will evaluate the effectiveness of the multicomponent intervention in reducing fluoride exposure. With comprehensive methodological approaches and objective measurements, it will demonstrate significant improvements in fluoride levels in children and in parental knowledge, attitudes, and practices. It will contribute to child health programs, strengthen preventive strategies in oral health, impact public policy and community health, and open new lines of research on fluoride. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT07232888 Link:https://clinicaltrials.gov/study/NCT07232888.