Clinical Trials Directory

Trials / Completed

CompletedNCT05748054

Early Childhood Caries in Jordanian Children

Early Childhood Caries in Jordanian Children: Prevalence, Risk Factors and Prevention Using Silver Diamine Fluoride

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
159 (actual)
Sponsor
King Abdullah University Hospital · Academic / Other
Sex
All
Age
3 Years – 5 Years
Healthy volunteers
Accepted

Summary

In this cross sectional epidemiological study, we aimed to report the prevalence of early childhood caries (ECC) in children attending kindergartens in Jordan, and its associated risk factors. We also, aimed to determine the effectiveness of silver diamine fluoride as a caries control material and its acceptance among parents of children with ECC. Children (n=887) with mean age 4.64 ± 1.56 were examined. Among this sample there was a number of children (n=159) who were enrolled in a randomized controlled trial to study silver diamine fluoride efficacy in caries control. The sample consisted of two groups; the study group (children who received single spot application of 38% SDF) and control group (children who were examined only).

Detailed description

Background: Early childhood caries is a well-known international public health challenge amongst young children. Aims: To report the prevalence of early childhood caries in children attending kindergartens in Jordan, and its associated risk factors. To determine the effectiveness of silver diamine fluoride as a caries control material and its acceptance among parents of children with ECC. Methods: This is a cross sectional epidemiological study comprised of children (n=887) with mean age 4.64 ± 1.56 who attended kindergartens of different cities in Jordan, this sample received questionnaires to fill data related to their demographic, socioeconomic, oral hygiene, oral health, nursing and nutritional habits. These children were also examined to determine early childhood caries prevalence in Jordan. Among this sample there was a number of children (n=159) with the mean age 4.8 ± 0.85 who were planned to be involved in a sample of a randomized controlled trial to study silver diamine fluoride efficacy in caries control. The sample consisted of two groups; the study group (children who received single spot application of 38% SDF) and control group (children who were examined only). Application of SDF started after distribution and receiving back approval letters from children's parents accompanied with questionnaires for data related to the approval/disapproval of the application. The sample were followed up for 1 year.

Conditions

Interventions

TypeNameDescription
DRUGSilver Diamine FluorideA colourless solution known with its alkaline nature; it simply consists of a union of silver, fluoride and ammonia. It can be applied on caries cavities using a micro-brush.

Timeline

Start date
2019-11-01
Primary completion
2020-10-01
Completion
2021-02-01
First posted
2023-02-28
Last updated
2023-03-07

Locations

1 site across 1 country: Jordan

Source: ClinicalTrials.gov record NCT05748054. Inclusion in this directory is not an endorsement.