Impact of Oral Health Package and Fluoride Varnish on Schoolchildren
Randomized Clinical Trial to Evaluate the Impact on Oral Health of the "Oral Health Package Law" (School Daily Brushing Program) Combined, or Not, With Fluor Varnish Application on Schoolchildren of Mérida, Mexico.
This study tests if a daily brushing program and fluoride varnish can improve the dental health of schoolchildren aged 6 to 8 in Mérida, Mexico.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 900 (estimated) |
| Ages | 6 Years to 8 Years |
| Sex | All |
| Sponsor | Anahuac Mayab University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Mérida, Yucatan) |
| Trial ID | NCT05960110 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a daily school brushing program combined with fluoride varnish application on the oral health of schoolchildren aged 6 to 8 in Mérida, Mexico. Participants will undergo dental screenings and receive specific oral hygiene instructions, including the use of fluoride toothpaste and supervised brushing sessions. The study will assess changes in caries, gum disease, and plaque levels over a two-year period, with follow-up evaluations and questionnaires to gather data on oral health outcomes.
Who should consider this trial
Good fit: Ideal candidates are healthy children aged 6 to 8 years enrolled in first, second, or third grade of primary education in Mérida.
Not a fit: Children with allergies to oral care products or those with specific dental conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve oral health and reduce the incidence of caries and gum disease among schoolchildren.
How similar studies have performed: Previous studies have shown positive outcomes with similar oral health interventions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1. Men and women, between 6-8 years of age; * 2. Children enrolled in first, second and third grade of primary education * 3. Availability during the duration of the study; * 4. Good general health (absence of any condition that, in the opinion of the Principal Investigator, could constitute a risk to the subject while participating in the study. * 5 Examples include heart problems, valve/hip replacements, etc.); * 6 Willingness to provide information related to his medical history; * 7 Informed consent form signed by the caregiver; * 8 Informed consent signed by the child Exclusion Criteria: * 1 Subjects must not have any of the following: * 2 The caregiver is unwilling to sign the informed consent form * 3 Subject participating in any other clinical study; * 4. Subject allergic to oral care products, consumer personal care products or their ingredients; * 5. Subjects with orthodontic bands, removable partial dentures, tumors of the hard parts or soft tissue of the oral cavity, or advanced periodontal disease * 6. Continued use of medications known to affect gingival tissues (ie, calcium channel blockers, phenytoin, cyclosporine); * 7. Subject is currently receiving chemotherapy * 8. Subject has leukemia
Where this trial is running
Mérida, Yucatan
- Anahuac Mayab University — Mérida, Yucatan, Mexico (Recruiting)
Study contacts
- Study coordinator: Mildred Salas, DDS
- Email: mildred.salas@anahuac.mx
- Phone: +52 999 134 7391
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.