Early Childhood Caries (ECC), Dental Caries
Conditions
Keywords
silver diamine fluoride
Brief summary
Early Childhood Caries (ECC) remains a global public health concern, necessitating minimally invasive, fluoride-based alternatives to conventional restorative therapy. Silver Diamine Fluoride (SDF), Sodium Fluoride with Casein Phosphopeptide-Amorphous Calcium Phosphate (NaF + CPP-ACP), and Acidulated Phosphate Fluoride (APF) gel are widely employed chemotherapeutic agents; however, comparative clinical evidence of their effectiveness in ECC management remains limited. This randomized controlled clinical trial will evaluate and compare the efficacy of SDF gel, NaF + CPP-ACP, and APF gel in arresting and preventing ECC.
Interventions
Silver diamine fluoride gel is applied in gel form
This is in a Topical fluoride varnish
DRUGAcidulated phospahate fluoride gel 1.23%
This is a topical fluoride application for 1 minute application
Sponsors
University of Jazan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
This three-arm phase 2 clinical trial will be conducted to evaluate the effectiveness of silver diamine fluoride (SDF) for preventing or arresting dental caries.
Eligibility
Sex/Gender
ALL
Age
2 Years to 9 Years
Healthy volunteers
No
Inclusion criteria
* The participants who had at least one untreated cavitated active caries lesion with dentin exposed based on the Nyvad criteria (level 3: "Enamel/dentin cavity easily visible with the naked eye where the surface of cavity feels soft or leathery on gentle probing", characterized by dentin exposure without signs of pulp involvement, pain, abscess, sinus tract, or mobility. * Medically healthy children with no systemic disorders or developmental anomalies
Exclusion criteria
* Parents refused consent for study * Any child with special health care needs or with any systemic ailments will be excluded from the study * Teeth exhibiting irreversible pulpitis, abscess, pathological mobility, pathological radiographic changes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dental caries arrest | Caries arrest will be assessed 6 months after intervention | A lesion was considered active if a blunt dental probe penetrated the dentinal surface easily, whereas arrested caries resisted probe penetration, indicating surface hardening. |
Countries
Saudi Arabia
Outcome results
None listed