Improving Dental Health Among Toddlers in the Dominican Republic

Not Applicable

Completed

• Conditions: Dental Caries in Children; Dental Caries
• Interventions: Behavioral: Oral Health education including printed educational material

• Registration Number: NCT04101617
• Lead Sponsor: Universidad Iberoamericana

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-13
• Study First Submitted: 2019-09-19
• Study First Submitted QC: 2019-09-23
• Study First Posted: 2019-09-24
• Primary Completion: 2021-06-01
• Study Completion: 2021-08-01
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-17
• Last Update Posted: 2021-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 306

Inclusion Criteria

• Healthy children
• Parents agreed to participate in the program

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Oral Health education including printed educational material	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.

Primary Outcome Measures

Name	Time	Method
Dental caries status	Up to ten months	Detection of dental caries lesions using the International Caries Detection and Assessment System (ICDAS) criteria.

Trial Locations

Locations (1)

Hospital General Plaza de la Salud; 🇩🇴 Santo Domingo, Distrito Nacional, Dominican Republic