Randomized Clinical Trial: Oral Health Package Law and Fluor Varnish Impact on Schoolchildren in Merida, Mexico (DBMX)
Caries, Gum Disease
About this trial
This is an interventional prevention trial for Caries focused on measuring Caries, gum disease
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
Sites / Locations
- Anahuac Mayab UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Test Group
Control Group
Fluoride toothpaste and fluoride varnish
Fluoride toothpaste