Effectiveness and Acceptability of SDF Compared to ART for the Management of Early Childhood Caries
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age24-71
SponsorUniversidad de La Frontera
About this trial
The goal 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 at the community level. The main question it aims to answer are:
• It's SDF more accepted and effective than ART in early childhood caries management when implemented at the community level?
Participants will be diagnosed by an experienced and calibrated dentist using the International Caries Detection and Assessment System (ICDAS), then children with decayed teeth will be treated with SDF (experimental) or ART (control); another operator will choose randomly the treatment for each participant. Furthermore, oral health education component will be given to children, parents and educators.
Follow-up visits will be made at 6 and 12 months after child's treatment is complete. Before and after treatment parents will be asked to complete a child personal background survey (before), Early Childhood Oral Health Impact Scale (ECOHIS) questionnaire (before and at follow-ups) and a oral health satisfaction survey (one week after treatment and at follow-ups). The acceptability will be assessed through quantitative and qualitative methods.
Researchers will compare the SDF's groups and the ART's group to see which of them is more accepted and effective.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Silver Diamine Fluoride
- Atraumatic Restorative Treatment
Treatment groups
156 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov