Fluorosis, DentalNCT07232888
Design of a Multicomponent Intervention to Reduce the Risk of Exposure Fluorine
A study testing multicomponent intervention and Conventional intervention in people with Fluorosis, Dental and Fluorosis, run by Universidad Antonio Nariño at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Fluorosis, Dental, Fluorosis
- What is being tested?
- multicomponent intervention and Conventional intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteColombia
- Study dates
- 2 May 2025to 29 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Fluorosis, Dental, Fluorosis
- Being tested
- multicomponent intervention, Conventional intervention
- Keywords
- Fluorine, Fluorides, Enamel fluorosis, Primary prevention, Health education
- Medical subject headings
- Fluorosis, Dental, Fluoride Poisoning, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multicomponent interventionBehavioural
- Installation of physical barriers: a reverse osmosis water filter.
- Educational sessions for parents: three thematic modules.
- Educational sessions for children: one thematic modules.
- Outreach activities: To ensure the sustainability of the intervention.
- 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 interventionBehavioural
The intervention will include training on the cariogenic diet, flossing, and hand washing.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Side | Experimental | Not described Receives: Behavioral: multicomponent intervention |
| Control side | Active comparator | Not described Receives: Behavioral: Conventional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary fluoride concentrations.
Decrease in urinary fluoride concentrations in children.
Measured: Baseline, 3 , 6, and 12 months.
Secondary outcomes (2)
Knowledge, attitudes, and practices (KAP).
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.
Measured: Baseline, 3 , 6 and 12 months.
fluoride concentrations in water.
Reduction in fluoride concentrations in water.
Measured: baseline, 3, 6, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start2 May 2025
- Primary completion30 May 2026 (estimated)
- Study completion29 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fluorosis, DentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Antonio Nariño
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232888
- Sponsor's protocol ID
- UAN-Fluoride
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garcia-Rojas CL, Perdomo AKF, Martinez JO, Losada-Farfan W, Llanos AB, Mendez YAL, Robledo MCG, Martinez-Mier EA, Colmenares GG. Design of a multicomponent intervention to reduce the risk of exposure to high concentrations of fluoride in children in Huila, Colombia. Contemp Clin Trials. 2026 Jun;165:108328. doi: 10.1016/j.cct.2026.108328. Epub 2026 Apr 22.
PubMed 42031231
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design of a Multicomponent Intervention to Reduce the Risk of Exposure to High Concentrations of Fluoride in Children in Huila, Colombia
- ClinicalTrials.gov ID
- NCT07232888
- Acronym / sponsor ID
- UAN-Fluoride
- Conditions
- Fluorosis, Dental, Fluorosis
- Keywords
- Fluorine, Fluorides, Enamel fluorosis, Primary prevention, Health education
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Universidad Antonio NariñoUniversity, hospital or other
- Study start
- 2 May 2025 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 29 Aug 2027 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Side | Experimental | Behavioral: multicomponent intervention |
| Control side | Active comparator | Behavioral: Conventional intervention |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multicomponent intervention1. 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) | Behavioural | Experimental Side |
| Conventional interventionThe intervention will include training on the cariogenic diet, flossing, and hand washing. | Behavioural | Control side |
Primary outcome
Urinary fluoride concentrations.
Time frame: Baseline, 3 , 6, and 12 months.
Decrease in urinary fluoride concentrations in children.
2 secondary outcomes
Knowledge, attitudes, and practices (KAP).
Time frame: Baseline, 3 , 6 and 12 months.
fluoride concentrations in water.
Time frame: baseline, 3, 6, and 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Derived from this study: PubMed 42031231Garcia-Rojas CL, Perdomo AKF, Martinez JO, Losada-Farfan W, Llanos AB, Mendez YAL, Robledo MCG, Martinez-Mier EA, Colmenares GG. Design of a multicomponent intervention to reduce the risk of exposure to high concentrations of fluoride in children in Huila, Colombia. Contemp Clin Trials. 2026 Jun;165:108328. doi: 10.1016/j.cct.2026.108328. Epub 2026 Apr 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multicomponent intervention and Conventional intervention in people with Fluorosis, Dental and Fluorosis, run by Universidad Antonio Nariño at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary fluoride concentrations. (time frame: Baseline, 3 , 6, and 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07232888, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.