Improving Dental Health Among Toddlers in the Dominican Republic

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04101617
• Other study ID #: CEI2017-14
• Status: Completed
• Phase: N/A
• Start date: February 13, 2019
• Est. completion date: August 1, 2021

Study information

• Verified date: December 2021
• Source: Universidad Iberoamericana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: August 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Months to 12 Months

Eligibility

Inclusion Criteria:

• Healthy children

• Parents agreed to participate in the program

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

Behavioral:
• Oral Health education including printed educational material
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.

Locations

Country	Name	City	State
Dominican Republic	Hospital General Plaza de la Salud	Santo Domingo	Distrito Nacional

Sponsors (5)

Lead Sponsor	Collaborator
Universidad Iberoamericana	Borrow Foundation, Colgate Palmolive, Hospital General Plaza de la Salud, University of Copenhagen

Country where clinical trial is conducted

Dominican Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dental caries status	Detection of dental caries lesions using the International Caries Detection and Assessment System (ICDAS) criteria.	Up to ten months