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

Primary Purpose

Caries, Gum Disease

Status
Recruiting
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Fluoride varnish
Fluoride toothpaste
Sponsored by
Anahuac Mayab University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Caries focused on measuring Caries, gum disease

Eligibility Criteria

6 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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

Arm Type

Experimental

Sham Comparator

Arm Label

Test Group

Control Group

Arm Description

Fluoride toothpaste and fluoride varnish

Fluoride toothpaste

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 18, 2023
Last Updated
July 18, 2023
Sponsor
Anahuac Mayab University
Collaborators
Colgate Palmolive
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1. Study Identification

Unique Protocol Identification Number
NCT05960110
Brief Title
Randomized Clinical Trial: Oral Health Package Law and Fluor Varnish Impact on Schoolchildren in Merida, Mexico
Acronym
DBMX
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2023 (Actual)
Primary Completion Date
December 22, 2025 (Anticipated)
Study Completion Date
February 22, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Anahuac Mayab University
Collaborators
Colgate Palmolive

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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 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. 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. 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. 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. 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. 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries, Gum Disease
Keywords
Caries, gum disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A parallel randomized single-blinded clinical trial
Masking
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
Allocation
Randomized
Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test Group
Arm Type
Experimental
Arm Description
Fluoride toothpaste and fluoride varnish
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
Fluoride toothpaste
Intervention Type
Drug
Intervention Name(s)
Fluoride varnish
Intervention Description
Fluoride varnish 26200 ppm
Intervention Type
Drug
Intervention Name(s)
Fluoride toothpaste
Intervention Description
Fluoride toothpaste 1450 ppm
Primary Outcome Measure Information:
Title
Impact on oral health
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Caries assessment
Description
Caries will be evaluated by International Caries Detection and Assessment System (ICDAS) score
Time Frame
24 months
Title
Gingivitis assessment
Description
Gingivitis will be evaluated by Silness-Löe Index
Time Frame
24 months
Title
Plaque assessment
Description
Plaque assessment will be evaluated by Silness-Löe Index
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mildred Salas, DDS
Phone
+52 999 134 7391
Email
mildred.salas@anahuac.mx
First Name & Middle Initial & Last Name or Official Title & Degree
University Anahuac Mayab
Phone
+529999424800
Email
investigacionuam@anahuac.mx
Facility Information:
Facility Name
Anahuac Mayab University
City
Mérida
State/Province
Yucatan
ZIP/Postal Code
97302
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mildred Salas, DDS
Phone
+529991347391
Email
mildred.salas@anahuac.mx

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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