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

Sponsor

Anahuac Mayab University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05960110

Collaborator

Colgate Palmolive (Industry)

900

Enrollment

Location

Arms

32.1

Anticipated Duration (Months)

28.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Caries Gum Disease	Drug: Fluoride varnish Drug: Fluoride toothpaste	Phase 3

Detailed Description

First visit:

The child will be asked to report to the school clinic to be screened by the dentist and/or hygienist to determine if he or she is a suitable test subject. If the parents and the child decide to participate and is accepted into the study, the family need to follow a specific set of instructions. The child will not perform or receive any oral hygiene (other than that described below).

At the beginning of the study, the child's teeth and gums will be examined to determine if they are eligible to participate in the study. The parents/tutors will agree to use only the fluoride toothpaste provided for the duration of the study and will be required to brush

their teeth daily in the school setting. There will be no restrictions regarding eating habits. A clinical score will be made to assess the level of caries, gingivitis and plaque level of all teeth and will be recorded on the evaluation forms. Questionnaires will be completed, and the child will be provided with a medium soft-bristled toothbrush and a tube of household toothpaste. Supervised brushing will be performed by asking the child to coat the

toothbrush head with their assigned toothpaste and brush their teeth for two (2) minutes. Subsequently, the child may receive a topical application of fluoride varnish depending on which group they belong to in this clinical trial.

The participants and their family will be asked if they want to participate in the

teleconsultation program where they will have access to an information platform with sessions to connect with a professional to obtain oral health guidance.

Teleconsultation control - 3 months (optional)

They will be able to schedule a teleconsultation visit where they will connect with a dental professional to receive individualized care and recommendations for the child's oral health.

Visit 2 (6 months)

At the 6-month visit, the child's teeth and gums will be examined. They will agree to use only the fluoride toothpaste provided to them for the duration of the study and will be required to brush their teeth daily in the school setting. There will be no restrictions

regarding eating habits.

A clinical score will be made to assess the level of caries, gingivitis and plaque level of all teeth and will be recorded on the evaluation forms. Questionnaires will be completed and the child will be provided with a medium soft-bristled toothbrush and a tube of household toothpaste. Supervised brushing will be performed by asking the child to coat the

Teleconsultation control - 9 months (optional)

They will be able to schedule a teleconsultation visit where they will connect with a dental professional to receive individualized care and recommendations for the child's oral health.

Visit 3 (12 months)

At the 12-month visit, the child's teeth and gums will be examined. They will agree to use only the fluoride toothpaste provided to them for the duration of the study and will be

required to brush their teeth daily in the school setting. There will be no restrictions regarding eating habits.

Consultation control - 15 months (optional)

They will be able to schedule a teleconsultation visit where they will connect with a dental professional to receive individualized care and recommendations for the child's oral health.

Visit 4 (18 months)

At the 18-month visit, the child's teeth and gums will be examined. They will agree to use only the fluoride toothpaste provided to them for the duration of the study and will be

required to brush their teeth daily in the school setting. There will be no restrictions regarding eating habits.

Consultation control - 21 months (optional)

They will be able to schedule a teleconsultation visit where they will connect with a dental professional to receive individualized care and recommendations for the child's oral health.

Visit 5 (24 months)

At the 24-month visit, the child's teeth and gums will be examined. They will agree to use only the fluoride toothpaste provided to them for the duration of the study and will be

required to brush their teeth daily in the school setting. There will be no restrictions regarding eating habits.

While participating as a subject in this study, the child may not use any oral product other than the one given to him. The child cannot participate as a subject in any other clinical study. Also, the child may not use drugs, except over-the-counter pain relievers, during the course of the study. The parents or legal guardians agree to inform the investigator of any new medications the child plans to take, including, but not limited to, antibiotics, antiseptics, decongestants, and antihistamines.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

900 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A parallel randomized single-blinded clinical trialA parallel randomized single-blinded clinical trial

Masking:

Single (Outcomes Assessor)

Masking Description:

The outcomes assessor will be blinded to the treatment allocation of the participants. Coded data sheets are used to maintain the blinding

Primary Purpose:

Prevention

Official Title:

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.

Actual Study Start Date :

Jun 22, 2023

Anticipated Primary Completion Date :

Dec 22, 2025

Anticipated Study Completion Date :

Feb 22, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test Group Fluoride toothpaste and fluoride varnish	Drug: Fluoride varnish Fluoride varnish 26200 ppm
Sham Comparator: Control Group Fluoride toothpaste	Drug: Fluoride toothpaste Fluoride toothpaste 1450 ppm

Arm

Intervention/Treatment

Experimental: Test Group

Fluoride toothpaste and fluoride varnish

Drug: Fluoride varnish

Fluoride varnish 26200 ppm

Sham Comparator: Control Group

Fluoride toothpaste

Drug: Fluoride toothpaste

Fluoride toothpaste 1450 ppm

Outcome Measures

Primary Outcome Measures

Impact on oral health [24 months]
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.

Secondary Outcome Measures

Caries assessment [24 months]
Caries will be evaluated by International Caries Detection and Assessment System (ICDAS) score
Gingivitis assessment [24 months]
Gingivitis will be evaluated by Silness-Löe Index
Plaque assessment [24 months]
Plaque assessment will be evaluated by Silness-Löe Index

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 8 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

1. Men and women, between 6-8 years of age;
1. Children enrolled in first, second and third grade of primary education
1. Availability during the duration of the study;
1. 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;
1. Subject allergic to oral care products, consumer personal care products or their ingredients;
1. Subjects with orthodontic bands, removable partial dentures, tumors of the hard parts or soft tissue of the oral cavity, or advanced periodontal disease
1. Continued use of medications known to affect gingival tissues (ie, calcium channel blockers, phenytoin, cyclosporine);
1. Subject is currently receiving chemotherapy
1. Subject has leukemia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anahuac Mayab University	Mérida	Yucatan	Mexico	97302

Sponsors and Collaborators

Anahuac Mayab University
Colgate Palmolive

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mildred Beatriz Salas Ley, DDS orthodontic specialist, Anahuac Mayab University

ClinicalTrials.gov Identifier:

NCT05960110

Other Study ID Numbers:

AnahuacMayabU
EXT-2023-02-DB-FV-MEX

First Posted:

Jul 25, 2023

Last Update Posted:

Jul 25, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mildred Beatriz Salas Ley, DDS orthodontic specialist, Anahuac Mayab University

Caries, gum disease

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 25, 2023