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Not yet recruiting NCT07382245

Efficacy of Silver Diamine Fluoride Versus Nano-Silver Fluoride in Arresting Active Dentin Caries in Primary Teeth in Young Children

No phase Interventional Early Childhood Caries (ECC) Active Dentin Caries in Primary Molars

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nano-Silver Fluoride, Silver Diamine Fluoride.
Who it may be relevant to
Registry conditions: Early Childhood Caries (ECC), Active Dentin Caries in Primary Molars. Basic parameters: 3 years — 5 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Efficacy of Silver Diamine Fluoride Versus Nano-Silver Fluoride in Arresting Active Dentin Caries in Primary Teeth in Young Children: A Randomized Clinical Trial

Overview

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

  • Drug Nano-Silver Fluoride
    Chitosan (28,585 μg/ml), Silver (376.5 μg/ml) and Sodium fluoride (5028.3 μg/ml)
  • Drug Silver Diamine Fluoride
    38% Silver Diamine Fluoride

Primary outcome measures

  • Caries arrest of active dentin caries [Time frame: 1, 3, 6, 9 and 12 months]
Secondary outcome measures (3)
  • Discoloration of carious lesions [Time frame: 1, 3, 6, 9 and 12 months]
  • Post-operative pain [Time frame: 1, 3, 6, 9 and 12 months]
  • Parental satisfaction [Time frame: 1, 3, 6, 9 and 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Dentistry, MSA University — Giza

Identifiers

NCT: NCT07382245 · Khaled SDF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗