Dental Caries in Children
Conditions
Brief summary
This randomized clinical trial aims to compare the effectiveness of two topical fluoride application protocols, namely 38% silver diamine fluoride and sodium fluoride with added casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) in arresting dental caries in children.
Detailed description
The present randomized clinical study is aiming to evaluate the effectiveness of silver diamine fluoride (SDF) in arresting dentin caries lesions when compared to MI Varnish a 5% sodium fluoride varnish which also contains RECALDENT™\* (CPP-ACP): Casein Phosphopeptide-Amorphous Calcium Phosphate. For this, healthy children aged 4-8 years with at least one active dentin carious lesion will be allocated randomly to one of two treatment groups: Group (1) SDF and Group (2) MI Varnish. Each participant will be assigned to one treatment group to avoid the possible synergistic effect of the different agents. Parents/ guardians of each child will be fully informed regarding the study design, objectives and probable advantages and side effects especially the black discoloration of SDF before their involvement by written consent. The International Caries Detection and Assessment System (ICDAS II) will be used to determine caries diagnosis and activity.visual and tactile examination will be done with a WHO probe to assess the primary outcome. the secondary outcome will be conducted by a questionnaire given to the parents.
Interventions
DRUGsilver diamine fluoride
38% silver diamine fluoride liquid will be applied with a brush
DRUGMI Varnish
topical fluoride varnish with calcium and phosphate
Sponsors
University of Baghdad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
1. Normal healthy children without any systemic disease ASA 1 physical status. 2. Children with at least one carious dentin lesion in their primary teeth, code 5 (ICDAS II)
Exclusion criteria
1. Children who suffer from major systemic diseases and require long term medications. 2. Children refuse the study intervention. 3. Children with silver or milk product sensitivity. 4. Presence of any gingival or perioral ulceration or stomatitis. 5. Tooth with abscess, fistula or severe pain.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| caries arrestment | 2 weeks | The measure will be done using international caries detection and assessment system II (ICDAS II) criteria for diagnosing active and arrested caries by WHO probe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parent perception | 0 - 2 weeks | parental perception for silver diamine fluoride staining will be conducted by questionnaire given to the parents |
Countries
Iraq
Outcome results
None listed