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Early Childhood Caries in Jordanian Children

K

King Abdullah University Hospital

Status

Completed

Conditions

Early Childhood Caries

Treatments

Drug: Silver Diamine Fluoride

Study type

Interventional

Funder types

Other

Identifiers

NCT05748054
47/2019

Details and patient eligibility

About

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).

Full 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.

Enrollment

159 patients

Sex

All

Ages

3 to 5 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

159 participants in 2 patient groups

Study group
Active Comparator group
Description:
Children who receive a single application of 38% SDF
Treatment:
Drug: Silver Diamine Fluoride
Control group
No Intervention group
Description:
Children do not receive any intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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