Completed

Cooperation Between Dentists and Pediatricians to Improve Dental Health Among Toddlers in the Dominican Republic

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What is being tested

Oral Health education including printed educational material

Behavioral
Who is being recruted

Dental Caries+1

+ Stomatognathic Diseases

+ Tooth Diseases

From 10 to 12 Months
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: February 2019
See protocol details

Summary

Principal SponsorUniversidad Iberoamericana
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 13, 2019

Actual date on which the first participant was enrolled.

Caries prevalence in the Dominican Republic (DR) seems high, although recent information is lacking. In DR there is a growth and development program for all children from the age of 0 to 5.Even though there is a mandatory educational health program for children and parents in this program, where periodically pediatricians examine them, this program does not include oral health education/prevention. Thus, it is proposed A) to devise materials to be used by pediatricians to share relevant information about caries control to parents of toddlers, and B) to evaluate the impact of such material on caries prevention for groups of toddlers over a 1.5-year period. Educational material will be developed for parents, and the pediatricians will deliver this material to 10-months-old children randomly selected at Plaza de la Salud Hospital. The PI will train the pediatricians in caries prevention and how to deliver the information to the parents in a clear manner. A total of 306 will be allocated into two groups. The experimental group (128 children) will receive the devised educational materials at 10 months, follow-up information will be provided at growth and development visits when the child is 18-, and 24 months old. The second group will be considered as the control group and will not receive any educational materials (178 children). All the enrolled children will receive fluoride containing toothpaste and tooth brushes. After 18 months when the children will be about 3 years old they will be examined to assess dental caries status. A sample mortality rate of 40% is expected during the two-year follow-up. Differences in caries status between the two groups will be examined using Welch's independent t-tests for unequal variances.

Official TitleCooperation Between Dentists and Pediatricians to Improve Dental Health Among Toddlers in the Dominican Republic
NCT04101617
Principal SponsorUniversidad Iberoamericana
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

306 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 10 to 12 Months

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Dental CariesStomatognathic DiseasesTooth DiseasesTooth Demineralization

Criteria

Inclusion Criteria: * Healthy children * Parents agreed to participate in the program Exclusion Criteria: \-

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will receive previously designed educational material with recommendations for healthy habits and oral health recommendations. Also, pediatricians will give the parents oral health education. Parents and their children will receive toothbrushes as well as toothpaste.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Hospital General Plaza de la Salud

Santo Domingo, Dominican RepublicOpen Hospital General Plaza de la Salud in Google Maps
CompletedOne Study Center
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