Clinical trial

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

Name
47/2019
Description
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 arms
Trial start
2019-11-01
Estimated PCD
2020-10-01
Trial end
2021-02-01
Status
Completed
Treatment
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.
Arms:
Study group
Other names:
SDF
Size
159
Primary endpoint
Prevalence of early childhood caries
After 1 year
Caries Prevention
After 1 year of SDF application
Caries arrest
After 1 year of SDF application
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 159, 'type': 'ACTUAL'}}
Updated at
2023-03-07

1 organization

1 product

1 indication