Effectiveness and Acceptability of SDF Compared to ART for the Management of Early Childhood Caries
156 patients around the world
Available in Chile
An open-label parallel superiority randomized clinical trial (RCT) will be conducted
involving children aged 2 to 5 years.
The aim of this clinical trial is to assess the acceptability and clinical effectiveness
of Silver Diamine Fluoride (SDF) in comparison with Atraumatic Restorative Treatment
(ART) in Early Childhood Caries (ECC) management. As well, this clinical trial sought to
compare the oral health quality of life related and to contrast possible adverse effects
between both therapies.
Participants will be screened and diagnosed by an experienced and calibrated dentist
using the International Caries Detection and Assessment System (ICDAS), thereafter only
children with decayed teeth (or tooth) will be treated. After the diagnostic participants
eligibles will be randomly chosen by another operator to be treated with SDF or ART for
all teeth who need treatment in the child:
- Experimental: SDF application in decayed teeth and oral health education component.
- Control: ART technique in decayed teeth and oral health education component.
The oral health education component will be given to children, parents and educators.
The eligible children parents will be asked to fulfill a children personal background
survey (before treatment), the Early childhood oral health impact scale (ECOHIS)
questionnaire (before and after treatment at follow-ups) and a oral health satisfaction
survey (a week after treatment and at follow-ups). The acceptability will be assessed
through quantitative and qualitative methods.
A sample is: 234 teeth with carious lesions per group is estimated. Estimating an average
of three teeth with carious lesions per child, 78 children are necessary per group.
Universidad de La Frontera
1Research sites
156Patients around the world
This study is for people with
Dental and oral disorders
Cavities
Requirements for the patient
To 71 Months
All Gender
Medical requirements
Children belonging to INTEGRA or JUNJI kindergarten, from 2 years up to 5 years and 11 months with informed consent signed by parents and assent from the child.
Children with at least one active cavitated caries lesion, extended in dentin with no signs of pulp involvement and diagnosed with ICDAS code 5.
Children with underlying systemic disease or disability.
Children with known allergies to dental materials used.
Children with transitory residence.
Children with severe alterations of the dental estructure.