CompletedNot Applicable

Cost-effectiveness of Topical Fluoride in Preventing Deciduous Dental Caries in Preschool Children

1,083 participantsStarted 2016-07-01

Plain-language summary

Fluoride foam and fluoride varnish are effectiveness in prevention deciduous dental caries. However, the relative clinical efficacy and cost-effectiveness of these two interventions are uncertain. This study aims to evaluate the relative clinical effectiveness and cost-effectiveness of fluoride foam and fluoride varnish in preventing dental caries in the primary teeth of preschool children with high caries risk.

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.

Kindergartens Inclusion Criteria: * Kindergartens which are all located in Harbin, Heilongjiang Province, China; * Kindergartens which are basically the same in terms of school scale, student source structure, economic level and sanitary conditions; * Kindergartens with the same source of domestic water, or with the same fluoride concentration in water , and the fluoride concentration in water less than 1.0mg/L. Children Inclusion Criteria: * Children aged over 3-year and under 4-year at the time of the survey; * Children in good health; * Children with a certain degree of understanding and good compliance; * Children whose parents sign the informed consent form. Exclusion Criteria: * Children who are unable to cooperate or have a strong vomiting reflex; * Children with a history of asthma or allergies; * Children with other contraindications specified in the product manual.

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

The mean number of decayed,missing and filled teeth at baseline,12 months and 24 months

Timeframe: 24 months

The mean number of decayed,missing and filled teeth surfaces at baseline,12 months and 24 months

Timeframe: 24 months

The change of mean number of decayed,missing and filled teeth at baseline,12 months and 24 months

Timeframe: 24 months

The change of mean number of decayed,missing and filled teeth surfaces at baseline,12 months and 24 months

Timeframe: 24 months

Trial details

NCT IDNCT05025163

SponsorNational Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-10-16

View on ClinicalTrials.gov More Dental Caries in Children trials

Plain-language summary

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.

What they're measuring

The mean number of decayed,missing and filled teeth at baseline,12 months and 24 months

Timeframe: 24 months

The mean number of decayed,missing and filled teeth surfaces at baseline,12 months and 24 months

Timeframe: 24 months

The change of mean number of decayed,missing and filled teeth at baseline,12 months and 24 months

Timeframe: 24 months

The change of mean number of decayed,missing and filled teeth surfaces at baseline,12 months and 24 months

Timeframe: 24 months