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.

AnahuacMayabU

Study aimed at evaluating the impact on oral health of the "Ley del Paquete de Salud Bucal" (daily school brushing program) combined, or not, with the application of fluoride varnish in schoolchildren from 6 to 8 years old who attend public elementary schools in Mérida, Mexico. with a two-year follow-up (2023-2025).

2023-06-22

2025-12-22

2026-02-22

Recruiting

Early phase I

900

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A parallel randomized single-blinded clinical trial', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'The outcomes assessor will be blinded to the treatment allocation of the participants. Coded data sheets are used to maintain the blinding', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 900, 'type': 'ESTIMATED'}}

2023-07-25