Early Childhood Caries in Jordanian Children

Early Childhood Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05748054
• Other study ID #: 47/2019
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: February 1, 2021

Study information

• Verified date: February 2023
• Source: King Abdullah University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: February 1, 2021
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Early Childhood Caries

Intervention

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.

Locations

Country	Name	City	State
Jordan	Jordan University of Science and Technology	Irbid

Sponsors (2)

Lead Sponsor	Collaborator
King Abdullah University Hospital	Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

Ramos-Gomez FJ, Shepard DS. Cost-effectiveness model for prevention of early childhood caries. J Calif Dent Assoc. 1999 Jul;27(7):539-44. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of early childhood caries	The percentage of children with early childhood caries	After 1 year
Primary	Caries Prevention	Prevention of new cavities	After 1 year of SDF application
Primary	Caries arrest	Arrest of existing cavities	After 1 year of SDF application
Secondary	Risk factors for early childhood caries	Early childhood caries risk factors questionnaire	After 1 year
Secondary	Parental acceptance of SDF	Reasons for acceptance or unacceptance of SDF application	Before application of SDF