Comparing three ways to prevent cavities in children's first permanent molars
Comparison of Efficacy of Three Preventive Methods to Reduce the Incidence of Coronal Caries in Mexican Schoolchildren: a Randomized Clinical Trial.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 204 (estimated) |
| Ages | 6 Years to 8 Years |
| Sex | All |
| Sponsor | Universidad Nacional Autonoma de Mexico Academic / other |
| Locations | 3 sites (Nezahualcóyotl, State of Mexico and 2 other locations) |
| Trial ID | NCT07131358 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Nezahualcóyotl, State of Mexico and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.