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OpenTrials
Completed

NCT Number: NCT04101617

Improving Dental Health Among Toddlers in the Dominican Republic

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.

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Key information

Age range

10 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital General Plaza de la Salud

Santo Domingo, Nacional, Dominican Republic

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy children
  • Parents agreed to participate in the program

Exclusion criteria

-

Treatment and study plan

Oral Health education including printed educational material

Behavioral

Printed and online educational materials were developed and provided to pediatricians so they can share relevant information about caries control to parents of toddlers. A previous interview was performed to pediatricians as focus groups to know how they are doing their evaluations and what do they take into account during the children visits in order to identify where to focus for the training what it is necessary to change. After that pediatricians were trained to give oral health recommendations. So, to the intervention group, the pediatricians will give these recommendations to the parents and also they will give them a printed educational material previously developed for the project.

Primary outcomes

  1. Dental caries status

    Time frame: Up to ten months

    Detection of dental caries lesions using the International Caries Detection and Assessment System (ICDAS) criteria.

Sponsors and collaborators

Lead sponsor

Universidad Iberoamericana

Other

Collaborators

  • Borrow Foundation
  • Colgate Palmolive
  • Hospital General Plaza de la Salud
  • University of Copenhagen

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 24, 2019
Registry last updated
Dec 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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