Improving Dental Health Among Toddlers in the Dominican Republic

NCT ID: NCT04101617

Last Updated: 2021-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 306 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-13
• Study Completion Date: 2021-08-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Oral Health education including printed educational material

Intervention Type: 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.

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Healthy children
• Parents agreed to participate in the program

Exclusion Criteria

-

• Minimum Eligible Age: 10 Months
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Copenhagen

OTHER

Sponsor Role: collaborator

Borrow Foundation

UNKNOWN

Sponsor Role: collaborator

Hospital General Plaza de la Salud

UNKNOWN

Sponsor Role: collaborator

Colgate Palmolive

INDUSTRY

Sponsor Role: collaborator

Universidad Iberoamericana

OTHER

Sponsor Role: lead

Responsible Party

Ninoska Abreu Placeres

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kim Ekstrand, PhD

Role: STUDY_DIRECTOR

The University of Copenhagen

Locations

Hospital General Plaza de la Salud

Santo Domingo, Nacional, Dominican Republic

Countries

Dominican Republic

Other Identifiers

CEI2017-14

Identifier Type: -

Identifier Source: org_study_id