Early Childhood Caries
Conditions
Keywords
Caries arrest, early childhood caries, Nanosilver fluoride
Brief summary
Aim of the study: To evaluate and compare the clinical cariostatic efficacy of NSF with 38% SDF solution after sex and twelve months in arresting ECC lesions. The Null hypothesis will be that no statistically significant difference will be detected between the two groups in the arrest of carious lesions in children with ECC.
Interventions
DRUGNanosilver
preventive material for arresting caries
DRUGSilver diamine fluoride
preventive material for arresting caries
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 4 Years
Healthy volunteers
No
Inclusion criteria
* Children younger than 4 years old. * The presence of at least one active carious lesion on a primary tooth, with scores 3 and higher (according to the International Detection and Assessment System- ICDAS II) * Completion of an informed consent to participate in the study.
Exclusion criteria
* Children reporting spontaneous or elicited pain from caries or showing any signs of pulpal infection, swelling and/or abscess, obvious discoloration of the tooth and premature hypermobility. * Parental refusal to participate in the study. * Allergy or sensitivity to silver or any of the materials included in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| caries arrest | 6 months and 1 year | percentage of arresting caries in primary teeth |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparing parental satisfaction and adverse effects with interventions | 6 months | assessed by a self-rated questionnaire with responses on a 4-point Likert scale ranging from very satisfied, satisfied, unsatisfied, to very unsatisfied - Parents were also asked about adverse effects |
| Evaluating oral health related quality of life of children and their families. | 6 months and 1 year | by using the Arabic version of the Early Childhood Oral Health Impact Scale (A-ECOHIS) |
| Assessing caries increment on remaining teeth in the oral cavity other than the tooth/ teeth receiving the preventive agent | 6 months and 1 year | caries increment which is the number of new caries lesions developed over the study period detected using dmfs (change in dmfs score) |
Countries
Egypt
Outcome results
None listed