Randomized Clinical Trial: Oral Health Package Law and Fluor Varnish Impact on Schoolchildren in Merida, Mexico

Launched by ANAHUAC MAYAB UNIVERSITY · Jul 18, 2023

Keywords

ClinConnect Summary

This clinical trial, called the "Randomized Clinical Trial: Oral Health Package Law and Fluor Varnish Impact on Schoolchildren in Merida, Mexico," is studying how a daily school brushing program and the use of fluoride varnish can improve oral health in children aged 6 to 8 years old. The focus is on preventing problems like cavities and gum disease among schoolchildren in public elementary schools in Mérida, Mexico. The study will follow participants for two years, from 2023 to 2025, to see how these methods affect their dental health.

To participate, children need to be between 6 and 8 years old, currently enrolled in the first three grades of elementary school, and in good general health. Parents or caregivers must also be willing to provide consent for their child to join the study. However, children with certain health issues, allergies to oral care products, or those currently undergoing treatments like chemotherapy will not be eligible. Participants can expect regular check-ups and guidance on oral health during the trial, helping them learn good brushing habits while also receiving fluoride treatment to strengthen their teeth.

Gender

ALL

Eligibility 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