Hospital General Plaza de la Salud
Santo Domingo, Nacional, Dominican Republic
NCT Number: NCT04101617
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.
Looking for future studies?
Notify Me10 month–12 month
All sexes
Interventional
Not applicable
Santo Domingo, Nacional, Dominican Republic
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-
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.
Time frame: Up to ten months
Detection of dental caries lesions using the International Caries Detection and Assessment System (ICDAS) criteria.
Universidad Iberoamericana
Other
Cooperation Between Dentists and Pediatricians to Improve Dental Health Among Toddlers in the Dominican Republic
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06829550
Congenital Abnormalities, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Indianapolis, Indiana, United States
View Trial DetailsNCT07023939
Dental Caries, Dental Caries in Children
Beirut, Lebanon
View Trial DetailsNCT03770286
Dental Caries, Dental Caries Class II
Los Angeles, California, United States
View Trial DetailsNCT06558747
Dental Caries, Dental Caries in Children
Antalya, Turkey (Türkiye)
View Trial Details