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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Early Childhood Caries (ECC); Active Dentin Caries in Primary Molars
• Intervention / Treatment: Drug: Nano-Silver Fluoride; Drug: Silver Diamine Fluoride

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Khaled Abdelmonem Sayed Assistant Lecturer at Pediatric Dentistry Department, Master Holder; Phone Number: +201114537612; Email: kasayed@msa.edu.eg

Study Locations

• Egypt
  • Giza Governorate
    • Giza, Giza Governorate, Egypt, 12611
      • Faculty of Dentistry, MSA University
      • Contact: Khaled Abdelmonem, Master degree; Phone Number: 01114537612; Email: kasayed@msa.edu.eg
      • Principal Investigator: khaled Abdelmonem, master degree

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Nano-Silver Fluoride; 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; Chitosan (28,585 μg/ml), Silver (376.5 μg/ml) and Sodium fluoride (5028.3 μg/ml)
Active Comparator: Arm B: Silver Diamine 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; 38% Silver Diamine Fluoride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caries arrest of active dentin caries	Arrest of caries assessed clinically by hardness of dentin using blunt periodontal probe and ICDAS criteria	1, 3, 6, 9 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discoloration of carious lesions	Assessment of color change using standardized pre- and post-operative photographs	1, 3, 6, 9 and 12 months
Post-operative pain	Presence or absence of pain assessed through parental interview	1, 3, 6, 9 and 12 months
Parental satisfaction	Evaluation using a structured parental satisfaction questionnaire	1, 3, 6, 9 and 12 months

Collaborators and Investigators

• Sponsor: October University for Modern Sciences and Arts

Study record dates

Study Major Dates

• Study Start (Estimated): January 30, 2026
• Primary Completion (Estimated): February 25, 2026
• Study Completion (Estimated): March 15, 2026

Study Registration Dates

• First Submitted: January 25, 2026
• First Submitted That Met QC Criteria: January 25, 2026
• First Posted (Actual): February 2, 2026

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 25, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Silver Diamine Fluoride; SDF; Early Childhood Caries; primary molar; Nano-Silver Fluoride
• Additional Relevant MeSH Terms: silver diamine fluoride
• Other Study ID Numbers: Khaled SDF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No