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Improving Dental Health Among Toddlers in the Dominican Republic

Primary Purpose

Dental Caries in Children, Dental Caries

Status
Completed
Phase
Not Applicable
Locations
Dominican Republic
Study Type
Interventional
Intervention
Oral Health education including printed educational material
Sponsored by
Universidad Iberoamericana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries in Children

Eligibility Criteria

10 Months - 12 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy children
  • Parents agreed to participate in the program

Exclusion Criteria:

-

Sites / Locations

  • Hospital General Plaza de la Salud

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 19, 2019
Last Updated
December 17, 2021
Sponsor
Universidad Iberoamericana
Collaborators
University of Copenhagen, Borrow Foundation, Hospital General Plaza de la Salud, Colgate Palmolive
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1. Study Identification

Unique Protocol Identification Number
NCT04101617
Brief Title
Improving Dental Health Among Toddlers in the Dominican Republic
Official Title
Cooperation Between Dentists and Pediatricians to Improve Dental Health Among Toddlers in the Dominican Republic
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
February 13, 2019 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Iberoamericana
Collaborators
University of Copenhagen, Borrow Foundation, Hospital General Plaza de la Salud, Colgate Palmolive

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries in Children, Dental Caries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
306 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Parents and their children will receive toothbrushes as well as toothpaste.
Intervention Type
Behavioral
Intervention Name(s)
Oral Health education including printed educational material
Intervention Description
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 Outcome Measure Information:
Title
Dental caries status
Description
Detection of dental caries lesions using the International Caries Detection and Assessment System (ICDAS) criteria.
Time Frame
Up to ten months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy children Parents agreed to participate in the program Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Ekstrand, PhD
Organizational Affiliation
The University of Copenhagen
Official's Role
Study Director
Facility Information:
Facility Name
Hospital General Plaza de la Salud
City
Santo Domingo
State/Province
Distrito Nacional
Country
Dominican Republic

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Improving Dental Health Among Toddlers in the Dominican Republic

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