NCT05748054

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 28, 2023

Completed
Last Updated

March 7, 2023

Status Verified

February 1, 2023

Enrollment Period

11 months

First QC Date

February 5, 2023

Last Update Submit

March 5, 2023

Conditions

Early Childhood Caries

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Risk factors for early childhood caries

    After 1 year

  • Parental acceptance of SDF

    Before application of SDF

Study Arms (2)

Study group

ACTIVE COMPARATOR

Children who receive a single application of 38% SDF

Drug: Silver Diamine Fluoride

Control group

NO INTERVENTION

Children do not receive any intervention

Interventions

Silver Diamine FluorideDRUG

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.

Also known as: SDF
Study group

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordan University of Science and Technology

Irbid, 22110, Jordan

Location

Related Publications (5)

  • 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.

    PMID: 16040729BACKGROUND

  • 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.

    PMID: 23722131BACKGROUND

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

    PMID: 10530112BACKGROUND

  • 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.

    PMID: 22892463BACKGROUND

  • 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.

    PMID: 26831727BACKGROUND

MeSH Terms

Interventions

silver diamine fluoride

Study Officials

  • Ola B. Al-Batayneh

    Jordan University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2023

First Posted

February 28, 2023

Study Start

November 1, 2019

Primary Completion

October 1, 2020

Study Completion

February 1, 2021

Last Updated

March 7, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

JO(1)