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

NCT05960110 | Recruiting Phase 3

• 2 other identifiers: AnahuacMayabUEXT-2023-02-DB-FV-MEX
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Caries; Gum Disease

Keywords

Caries, gum disease

Outcome Measures

Primary Outcomes (1)

• Impact on oral health

  To evaluate 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.

  24 months

Secondary Outcomes (3)

• Caries assessment

  24 months

• Gingivitis assessment

  24 months

• Plaque assessment

  24 months

Study Arms (2)

Test Group

EXPERIMENTAL

Fluoride toothpaste and fluoride varnish

Drug: Fluoride varnish

Control Group

SHAM COMPARATOR

Fluoride toothpaste

Drug: Fluoride toothpaste

Interventions

Fluoride varnish DRUG

Fluoride varnish 26200 ppm

Test Group

Fluoride toothpaste DRUG

Fluoride toothpaste 1450 ppm

Control Group

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \. Men and women, between 6-8 years of age;
• \. Children enrolled in first, second and third grade of primary education
• \. Availability during the duration of the study;
• \. 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.
• Examples include heart problems, valve/hip replacements, etc.);
• Willingness to provide information related to his medical history;
• Informed consent form signed by the caregiver;
• Informed consent signed by the child

You may not qualify if:

• Subjects must not have any of the following:
• The caregiver is unwilling to sign the informed consent form
• Subject participating in any other clinical study;
• \. Subject allergic to oral care products, consumer personal care products or their ingredients;
• \. Subjects with orthodontic bands, removable partial dentures, tumors of the hard parts or soft tissue of the oral cavity, or advanced periodontal disease
• \. Continued use of medications known to affect gingival tissues (ie, calcium channel blockers, phenytoin, cyclosporine);
• \. Subject is currently receiving chemotherapy
• \. Subject has leukemia

Sponsors & Collaborators

• Anahuac Mayab University: lead
• Colgate Palmolive: collaborator

Study Sites (1)

Anahuac Mayab University

Mérida, Yucatán, 97302, Mexico

RECRUITING

MeSH Terms

Conditions

Gingival Diseases

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Mildred Salas, DDS

CONTACT

+52 999 134 7391; mildred.salas@anahuac.mx

University Anahuac Mayab

CONTACT

+529999424800; investigacionuam@anahuac.mx

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be blinded to the treatment allocation of the participants. Coded data sheets are used to maintain the blinding
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS orthodontic specialist

Model Details: A parallel randomized single-blinded clinical trial

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: July 25, 2023
• Study Start: June 22, 2023
• Primary Completion: December 22, 2025
• Study Completion: February 22, 2026
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)