Improving Dental Health Among Toddlers in the Dominican Republic

Sponsor

Universidad Iberoamericana (Other)

Overall Status

Completed

CT.gov ID

NCT04101617

Collaborator

University of Copenhagen (Other), Borrow Foundation (Other), Hospital General Plaza de la Salud (Other), Colgate Palmolive (Industry)

306

Enrollment

Location

Arms

29.6

Actual Duration (Months)

10.3

Patients Per Site Per Month

Study Details

Study Description

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

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries in Children Dental Caries	Behavioral: Oral Health education including printed educational material	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

306 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 13, 2019

Actual Primary Completion Date :

Jun 1, 2021

Actual Study Completion Date :

Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group 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 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.
No Intervention: Control Group Parents and their children will receive toothbrushes as well as toothpaste.

Arm

Intervention/Treatment

Experimental: Experimental group

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

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.

No Intervention: Control Group

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Months to 12 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy children
Parents agreed to participate in the program

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital General Plaza de la Salud	Santo Domingo	Distrito Nacional	Dominican Republic

Sponsors and Collaborators

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

Investigators

Study Director: Kim Ekstrand, PhD, The University of Copenhagen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ninoska Abreu Placeres, Researcher, Universidad Iberoamericana

ClinicalTrials.gov Identifier:

NCT04101617

Other Study ID Numbers:

CEI2017-14

First Posted:

Sep 24, 2019

Last Update Posted:

Dec 20, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dental Caries

Study Results

No Results Posted as of Dec 20, 2021