An interventional study of Nano-Silver Fluoride and Silver Diamine Fluoride in Early Childhood Caries (ECC) and Active Dentin Caries in Primary Molars, sponsored by October University for Modern Sciences and Arts. Not yet recruiting at 1 site in Egypt. Open to participants aged 3 Years to 5 Years. Per ClinicalTrials.gov, last updated 2026-02-02.
Sponsored by October University for Modern Sciences and Arts · Not applicable, Interventional, and Treatment
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.
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.
October University for Modern Sciences and Arts is the lead sponsor of 50 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Topical application of Nano-Silver Fluoride varnish containing silver nanoparticles, chitosan, and fluoride applied to active dentin caries lesions in primary molars. Application will be performed twice: at baseline and after 6 months, without caries excavation or restoration.
Drug: Nano-Silver Fluoride
Topical application of 38% Silver Diamine Fluoride varnish applied to active dentin caries lesions in primary molars. Application will be performed twice: at baseline and after 6 months, without caries excavation or restoration.
Drug: Silver Diamine Fluoride
Chitosan (28,585 μg/ml), Silver (376.5 μg/ml) and Sodium fluoride (5028.3 μg/ml)
38% Silver Diamine Fluoride
Caries arrest of active dentin caries
Arrest of caries assessed clinically by hardness of dentin using blunt periodontal probe and ICDAS criteria
Time frame: 1, 3, 6, 9 and 12 months
Discoloration of carious lesions
Assessment of color change using standardized pre- and post-operative photographs
Time frame: 1, 3, 6, 9 and 12 months
Post-operative pain
Presence or absence of pain assessed through parental interview
Time frame: 1, 3, 6, 9 and 12 months
Parental satisfaction
Evaluation using a structured parental satisfaction questionnaire
Time frame: 1, 3, 6, 9 and 12 months
Plan to share: Yes
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This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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October University for Modern Sciences and Arts