Early Childhood Caries in Jordanian Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2021-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Silver Diamine Fluoride Effectiveness Versus Atraumatic Restorative Treatment in Arresting ECC

NCT04514094

Early Childhood Caries

COMPLETED NA

SDF Effectiveness on Arresting Caries in Children

NCT05872542

Dental Caries in Children

RECRUITING PHASE4

Effectiveness of Nano-silver Fluoride and Silver Diamine Fluoride for Arresting Early Childhood Caries

NCT05255913

Early Childhood Caries

COMPLETED NA

Oral Health-Related Quality of Life of Early Childhood Caries Using Silver Diamine Fluoride Versus Drill and Fill Technique

NCT05337449

UNKNOWN NA

Evaluation Of Fluoride Uptake By Dentine Following Silver Diamine Fluoride Under Resin Modified Glass Ionomer Restoration In Carious Primary Molars

NCT04777968

Dental Caries

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Early Childhood Caries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study group

Children who receive a single application of 38% SDF

Group Type ACTIVE_COMPARATOR

Silver Diamine Fluoride

Intervention Type DRUG

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.

Control group

Children do not receive any intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

SDF

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes