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NCT Number: NCT07382245

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

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.

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Key information

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, MSA University

Giza, Giza Governorate, 12611, Egypt

Location contact

Khaled Abdelmonem, Master degree

CONTACT

[email protected]

01114537612

khaled Abdelmonem, master degree

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nano-Silver Fluoride

Drug

Chitosan (28,585 μg/ml), Silver (376.5 μg/ml) and Sodium fluoride (5028.3 μg/ml)

Silver diamine fluoride

Drug

38% Silver Diamine Fluoride

Primary outcomes

  1. Caries arrest of active dentin caries

    Time frame: 1, 3, 6, 9 and 12 months

    Arrest of caries assessed clinically by hardness of dentin using blunt periodontal probe and ICDAS criteria

Secondary outcomes

  1. Discoloration of carious lesions

    Time frame: 1, 3, 6, 9 and 12 months

    Assessment of color change using standardized pre- and post-operative photographs

  2. Post-operative pain

    Time frame: 1, 3, 6, 9 and 12 months

    Presence or absence of pain assessed through parental interview

  3. Parental satisfaction

    Time frame: 1, 3, 6, 9 and 12 months

    Evaluation using a structured parental satisfaction questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Khaled Abdelmonem Sayed Assistant Lecturer at Pediatric Dentistry Department, Master Holder

CONTACT

[email protected]

+201114537612

Sponsors and collaborators

Lead sponsor

October University for Modern Sciences and Arts

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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