Active Dentin Caries in Primary Molars, Early Childhood Caries (ECC)
Conditions
Keywords
Early Childhood Caries, primary molar, Nano-Silver Fluoride, Silver Diamine Fluoride, SDF
Brief summary
Early childhood caries is a major public health problem affecting preschool children worldwide. Silver Diamine Fluoride is a well-established non-invasive treatment for arresting caries; however, it causes black discoloration of treated lesions. Nano-Silver Fluoride has been introduced as an alternative that may arrest caries without discoloration. This randomized clinical trial aims to compare the efficacy of Silver Diamine Fluoride and Nano-Silver Fluoride in arresting active dentin caries in primary teeth and to assess discoloration, post-operative pain, and parental satisfaction over a 12-month follow-up period.
Detailed description
This randomized clinical trial will be conducted on 30 children aged 3-5 years attending the outpatient clinic of Pediatric Dentistry, Faculty of Dentistry, Suez Canal University. Children with active dentin caries in primary molars will be randomly allocated into two groups: Silver Diamine Fluoride group and Nano-Silver Fluoride group. Both materials will be applied topically without caries excavation. Clinical evaluation will be performed at baseline and at 1, 3, 6, 9, and 12 months using ICDAS criteria, visual and tactile examination, assessment of post-operative pain, discoloration through standardized photographs, and parental satisfaction questionnaires. The primary outcome is caries arrest. Secondary outcomes include discoloration, pain, and parental satisfaction.
Interventions
Chitosan (28,585 μg/ml), Silver (376.5 μg/ml) and Sodium fluoride (5028.3 μg/ml)
DRUGSilver Diamine Fluoride
38% Silver Diamine Fluoride
Sponsors
October University for Modern Sciences and Arts
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
* Apparently healthy children. * Children with age ranged from 3-5 years from both genders. * Children who refused dental treatment with Frankl Behavior Rating Scale 1 and 2. * Children having molars with active dentin caries score (2,3,4) according to International Caries Detection and Assessment System- ICDAS II, detected by visual and tactile. * Parents/guardians accept treatment and write informed consent.
Exclusion criteria
* Children with allergy to silver from their medical history. * Children with ulcerative gingivitis. * Children with primary molars with the following criteria: * Symptomatic * Involving the pulp * Presence of fistula or sinus * Presence of gingival inflammation and Pain on percussion * Close to exfoliation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caries arrest of active dentin caries | 1, 3, 6, 9 and 12 months | Arrest of caries assessed clinically by hardness of dentin using blunt periodontal probe and ICDAS criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Discoloration of carious lesions | 1, 3, 6, 9 and 12 months | Assessment of color change using standardized pre- and post-operative photographs |
| Post-operative pain | 1, 3, 6, 9 and 12 months | Presence or absence of pain assessed through parental interview |
| Parental satisfaction | 1, 3, 6, 9 and 12 months | Evaluation using a structured parental satisfaction questionnaire |
Countries
Egypt
Contacts
CONTACTKhaled Abdelmonem Sayed Assistant Lecturer at Pediatric Dentistry Department, Master Holder
Outcome results
None listed