About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Children with allergy to silver from their medical history.
Children with ulcerative gingivitis.
Symptomatic
Involving the pulp
Trial design
Parallel
Treatments tested in this trial
Nano-Silver Fluoride
DrugChitosan (28,585 μg/ml), Silver (376.5 μg/ml) and Sodium fluoride (5028.3 μg/ml)
Silver Diamine Fluoride
Drug38% Silver Diamine Fluoride
Treatment groups
Trial outcomes
Primary outcomes
Caries arrest of active dentin caries
Arrest of caries assessed clinically by hardness of dentin using blunt periodontal probe and ICDAS criteria
Secondary outcomes
Discoloration of carious lesions
Assessment of color change using standardized pre- and post-operative photographs
Post-operative pain
Presence or absence of pain assessed through parental interview
Parental satisfaction
Evaluation using a structured parental satisfaction questionnaire
Sponsors and contacts
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