Early Childhood Caries in Jordanian Children

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

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).

Study Overview

• Status: Completed
• Conditions: Early Childhood Caries
• Intervention / Treatment: Drug: Silver Diamine Fluoride

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 Type: Interventional
• Enrollment (Actual): 159
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jordan
  • Irbid, Jordan, 22110
    • Jordan University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 5 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of early childhood caries	The percentage of children with early childhood caries	After 1 year
Caries Prevention	Prevention of new cavities	After 1 year of SDF application
Caries arrest	Arrest of existing cavities	After 1 year of SDF application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental acceptance of SDF	Reasons for acceptance or unacceptance of SDF application	Before application of SDF
Risk factors for early childhood caries	Early childhood caries risk factors questionnaire	After 1 year

Collaborators and Investigators

• Sponsor: King Abdullah University Hospital
• Collaborators: Jordan University of Science and Technology

Publications and helpful links

General Publications

• Gao SS, Zhang S, Mei ML, Lo EC, Chu CH. Caries remineralisation and arresting effect in children by professionally applied fluoride treatment - a systematic review. BMC Oral Health. 2016 Feb 1;16:12. doi: 10.1186/s12903-016-0171-6.
• Llodra JC, Rodriguez A, Ferrer B, Menardia V, Ramos T, Morato M. Efficacy of silver diamine fluoride for caries reduction in primary teeth and first permanent molars of schoolchildren: 36-month clinical trial. J Dent Res. 2005 Aug;84(8):721-4. doi: 10.1177/154405910508400807.
• Mei ML, Chu CH, Low KH, Che CM, Lo EC. Caries arresting effect of silver diamine fluoride on dentine carious lesion with S. mutans and L. acidophilus dual-species cariogenic biofilm. Med Oral Patol Oral Cir Bucal. 2013 Nov 1;18(6):e824-31. doi: 10.4317/medoral.18831.
• Ramos-Gomez FJ, Shepard DS. Cost-effectiveness model for prevention of early childhood caries. J Calif Dent Assoc. 1999 Jul;27(7):539-44.
• Zhi QH, Lo EC, Lin HC. Randomized clinical trial on effectiveness of silver diamine fluoride and glass ionomer in arresting dentine caries in preschool children. J Dent. 2012 Nov;40(11):962-7. doi: 10.1016/j.jdent.2012.08.002. Epub 2012 Aug 11.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: February 5, 2023
• First Submitted That Met QC Criteria: February 17, 2023
• First Posted (Actual): February 28, 2023

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 5, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: 47/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No