CariesPhase 3DBMXNCT05960110
Randomized Clinical Trial: Oral Health Package Law and Fluor Varnish Impact on Schoolchildren in Merida, Mexico
A Phase 3 study testing Fluoride varnish and Fluoride toothpaste in people with Caries and Gum Disease, run by Anahuac Mayab University at 1 site in Mexico.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries, Gum Disease
- What is being tested?
- Fluoride varnish and Fluoride toothpaste
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 900 participants
- Where
- 1 siteMexico
- Study dates
- 22 Jun 2023to 22 Feb 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Anahuac Mayab University
Mérida, Yucatán, 97302
Mildred Salas, DDS, +529991347391, mildred.salas@anahuac.mx
About this study
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 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).
Read the 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.
- Conditions
- Caries, Gum Disease
- Being tested
- Fluoride varnish, Fluoride toothpaste
- Keywords
- Caries, gum disease
- Medical subject headings
- Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoride varnishDrug
Fluoride varnish 26200 ppm
Fluoride toothpasteDrug
Fluoride toothpaste 1450 ppm
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Fluoride toothpaste and fluoride varnish Receives: Drug: Fluoride varnish |
| Control Group | Sham comparator | Fluoride toothpaste Receives: Drug: Fluoride toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (3)
Caries assessment
Caries will be evaluated by International Caries Detection and Assessment System (ICDAS) score
Measured: 24 months
Gingivitis assessment
Gingivitis will be evaluated by Silness-Löe Index
Measured: 24 months
Plaque assessment
Plaque assessment will be evaluated by Silness-Löe Index
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start22 Jun 2023
- Primary completion22 Dec 2025 (estimated)
- Study completion22 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A parallel randomized single-blinded clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anahuac Mayab University
- Sponsor type
- University, hospital or other
- Collaborators
- Colgate Palmolive
- Responsible party
- Principal investigator, Mildred Beatriz Salas Ley, Anahuac Mayab University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960110
- Sponsor's protocol ID
- AnahuacMayabU
- Other IDs
- EXT-2023-02-DB-FV-MEX
- Acronym
- DBMX
- Status last verified
- Jul 2023
- First submitted
- 18 Jul 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05960110
- Acronym / sponsor ID
- DBMX / AnahuacMayabU
- Conditions
- Caries, Gum Disease
- Keywords
- Caries, gum disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Anahuac Mayab UniversityUniversity, hospital or other
- Collaborators
- Colgate Palmolive
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 22 Dec 2025 (estimated)
- Study completion
- 22 Feb 2026 (estimated)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A parallel randomized single-blinded clinical trial
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Drug: Fluoride varnishFluoride toothpaste and fluoride varnish |
| Control Group | Sham comparator | Drug: Fluoride toothpasteFluoride toothpaste |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.);
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluoride varnishFluoride varnish 26200 ppm | Drug | Test Group |
| Fluoride toothpasteFluoride toothpaste 1450 ppm | Drug | Control Group |
Primary outcome
Impact on oral health
Time frame: 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.
3 secondary outcomes
Caries assessment
Time frame: 24 months
Gingivitis assessment
Time frame: 24 months
Plaque assessment
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluoride varnish and Fluoride toothpaste in people with Caries and Gum Disease, run by Anahuac Mayab University at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mildred Salas, DDS (+52 999 134 7391, mildred.salas@anahuac.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact on oral health (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.