Improving Dental Health Among Toddlers in the Dominican Republic

NCT04101617 | Completed

• 1 other identifier: CEI2017-14
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Caries in Children; Dental Caries

Outcome Measures

Primary Outcomes (1)

• Dental caries status

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

  Up to ten months

Study Arms (2)

Experimental group

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.

Behavioral: Oral Health education including printed educational material

Control Group

NO INTERVENTION

Parents and their children will receive toothbrushes as well as toothpaste.

Interventions

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.

Experimental group

Eligibility Criteria

• Age: 10 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children
• Parents agreed to participate in the program

Sponsors & Collaborators

• Universidad Iberoamericana: lead
• University of Copenhagen: collaborator
• Borrow Foundation: collaborator
• Hospital General Plaza de la Salud: collaborator
• Colgate Palmolive: collaborator

Study Sites (1)

Hospital General Plaza de la Salud

Santo Domingo, Nacional, Dominican Republic

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Kim Ekstrand, PhD

  The University of Copenhagen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 24, 2019
• Study Start: February 13, 2019
• Primary Completion: June 1, 2021
• Study Completion: August 1, 2021
• Last Updated: December 20, 2021

Record last verified: 2021-12

Locations

DO (1)