CompletedNot Applicable

Fluoride Caries-control Effectiveness/Feasibility in Children

Colombia814 participantsStarted 2022-08-22

Plain-language summary

The aim of this study is to compare the effectiveness and feasibility of using silver diamine fluoride solution (SDF) vs. sodium fluoride varnish (NaF) for caries management in children from Bogotá (and its suburban areas) and Cartagena, in terms of: 1. Preventive effect: number of carious dental surfaces (cavitated); 2. Arrest effect: number of arrested carious tooth surfaces (cavitated); 3. Presence and number of adverse effects in soft/hard oral tissues. Null hypothesis: Effectiveness and feasibility of silver diamine fluoride is superior to the sodium fluoride for caries management: Alternative hypothesis: Effectiveness and feasibility of silver diamine fluoride is not superior to the sodium fluoride for caries management. This Randomize Clinical Trial included 752 3-4 year-old medically healthy children from Bogotá and Cartagena. Participants were randomized equality distributed per city to receive either SDF (38%) or NaF (5%) biannually. Primary outcomes: cavity prevention and arresting effect. Secondary: feasibility (adherence, fidelity), dental-care parental satisfaction/acceptance and adverse effects. Data were analysed using t-tests, Chi-square, and Generalized estimating equations -GEE (0.05 statistical significance).

Who can participate

Age range

3 Years – 4 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 3-4-year-old children (from Bogotá/Cartagena) * Informed consent signed. * Self-reported good general health (parents) Exclusion criteria: * Intention to move in the next 12 months * Systemic disease, physical/mental disability * Regularly medication intake * Non-cooperative children

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

one-year proportion of children with new cavities and mean number of new cavities (preventive effect)

Timeframe: 12 months

one-year proportion of children with inactive cavities and mean number of inactive cavities (arresting effect)

Timeframe: 12 months

Trial details

NCT IDNCT06690008

SponsorUniversidad El Bosque, Bogotá

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-30

View on ClinicalTrials.gov More Caries,Dental trials