Comparing three ways to prevent cavities in children's first permanent molars
Official title: Comparison of Efficacy of Three Preventive Methods to Reduce the Incidence of Coronal Caries in Mexican Schoolchildren: a Randomized Clinical Trial.
Run by Universidad Nacional Autonoma de Mexico · NCT07131358 · Data updated 2026-11-12
This project will test three prevention methods—fluoride varnish alone, a glass ionomer sealant plus fluoride varnish, and a Giomer® sealant—in Mexican schoolchildren aged 6–8 to see which best prevents cavities in their first permanent molars.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 8 Years |
| Sex | All |
| Enrollment | 204 (estimated) |
| Sponsor | Universidad Nacional Autonoma de Mexico Academic / other |
| Locations | 3 sites (Nezahualcóyotl, State of Mexico and 2 other locations) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | September 24, 2025 |
| Trial ID | NCT07131358 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 6–8 with at least one erupted first permanent molar, classified at moderate or high caries risk, who attend the participating public primary schools in Nezahualcóyotl are ideal candidates.
✕Probably not a fit
Children with incisor-molar hypomineralization, dental fluorosis, existing sealants on first permanent molars, disabilities preventing exams, or allergies to milk protein, methacrylate, or acetone may not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
About 204 children aged 6–8 from public primary schools in Nezahualcóyotl, State of Mexico, will be assigned to one of three groups (68 per group) receiving fluoride varnish alone, a conventional glass ionomer pit-and-fissure sealant plus fluoride varnish, or a pit-and-fissure sealant with Giomer® technology. Dental examinations at baseline and during follow-up will record the incidence of coronal caries in first permanent molars using standard diagnostic criteria. The trial focuses on children at moderate or high caries risk and excludes those with conditions such as hypomineralization, fluorosis, prior sealants, or relevant allergies. Results will compare how each preventive approach changes caries rates over the follow-up period to identify the most effective option for this population.
Why it matters
Potential benefit: If one method substantially lowers caries rates, it could reduce the need for dental treatment and improve children's oral health and quality of life.
How similar studies have gone: Fluoride varnish and conventional pit-and-fissure sealants have supporting evidence for caries prevention, but evidence for Giomer® sealants and for adding varnish to sealants is limited and inconclusive.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Schoolchildren between 6 and 8 years of age, of both sexes, with at least one erupted permanent first molar, healthy or with incipient caries (ICDAS codes 1 and 2), attending public primary schools in the State of Mexico located in the municipality of Nezahualcóyotl. * Schoolchildren with a moderate or high risk of tooth decay according to the caries risk assessment. Exclusion Criteria: * Schoolchildren with the presence of incisor-molar hypomineralization or dental fluorosis. * Schoolchildren with the presence of sealants of fissures and fissures or with a history of their placement in any of the first permanent molars. * School children who have a disability that prevents them from performing the oral clinical examination or interview. * Schoolchildren with allergies or suspected allergies to milk protein and its derivatives, methacrylate monomer and/or acetone.
Where it's running
-
Primary School "Belisario Dominguez"
Nezahualcóyotl, State of Mexico, Mexico Recruiting -
Primary School "Emiliano Zapata"
Nezahualcóyotl, State of Mexico, Mexico Recruiting -
Primary School "Venustiano Carranza"
Nezahualcóyotl, State of Mexico, Mexico Recruiting
Study contacts
- Study coordinator: Aida Borges, PhD
- Email: aborges@unam.mx
- Phone: (52) 55 56 22 55 48
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.