Early Childhood Caries in Jordanian Children

Sponsor
King Abdullah University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05748054
Collaborator
Jordan University of Science and Technology (Other)
159
1
2
15
10.6

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Silver Diamine Fluoride
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
159 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Early Childhood Caries in Jordanian Children: Prevalence, Risk Factors and Prevention Using Silver Diamine Fluoride
Actual Study Start Date :
Nov 1, 2019
Actual Primary Completion Date :
Oct 1, 2020
Actual Study Completion Date :
Feb 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Study group

Children who receive a single application of 38% SDF

Drug: Silver Diamine Fluoride
A 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.
Other Names:
  • SDF
  • No Intervention: Control group

    Children do not receive any intervention

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of early childhood caries [After 1 year]

      The percentage of children with early childhood caries

    2. Caries Prevention [After 1 year of SDF application]

      Prevention of new cavities

    3. Caries arrest [After 1 year of SDF application]

      Arrest of existing cavities

    Secondary Outcome Measures

    1. Risk factors for early childhood caries [After 1 year]

      Early childhood caries risk factors questionnaire

    2. Parental acceptance of SDF [Before application of SDF]

      Reasons for acceptance or unacceptance of SDF application

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 5 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Children with early childhood caries involving anterior and/or posterior primary teeth

    • Children with with cavitated lesions with active caries

    • Children with no clinical signs of pulp involvement

    Exclusion criteria:
    • Children with grossly broken down teeth

    • Children with teeth with more than one third of the crown missing

    • Children with pulpally involved teeth (with pulp exposure, presence of an abscess or a sinus) Children with obvious discoloration, and abnormal mobility

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jordan University of Science and Technology Irbid Jordan 22110

    Sponsors and Collaborators

    • King Abdullah University Hospital
    • Jordan University of Science and Technology

    Investigators

    • Principal Investigator: Ola B. Al-Batayneh, Jordan University of Science and Technology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    King Abdullah University Hospital
    ClinicalTrials.gov Identifier:
    NCT05748054
    Other Study ID Numbers:
    • 47/2019
    First Posted:
    Feb 28, 2023
    Last Update Posted:
    Mar 7, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 7, 2023