NCT07382245

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

January 30, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2026

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

26 days

First QC Date

January 25, 2026

Last Update Submit

January 25, 2026

Conditions

Early Childhood Caries (ECC)Active Dentin Caries in Primary Molars

Keywords

Early Childhood Cariesprimary molarNano-Silver FluorideSilver Diamine FluorideSDF

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Discoloration of carious lesions

    1, 3, 6, 9 and 12 months

  • Post-operative pain

    1, 3, 6, 9 and 12 months

  • Parental satisfaction

    1, 3, 6, 9 and 12 months

Study Arms (2)

Arm A: Nano-Silver Fluoride

EXPERIMENTAL

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

Arm B: Silver Diamine Fluoride

ACTIVE COMPARATOR

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

Interventions

Nano-Silver FluorideDRUG

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

Arm A: Nano-Silver Fluoride
Silver Diamine FluorideDRUG

38% Silver Diamine Fluoride

Arm B: Silver Diamine Fluoride

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, MSA University

Giza, Giza Governorate, 12611, Egypt

Location

MeSH Terms

Interventions

silver diamine fluoride

Central Study Contacts

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

CONTACT

+201114537612kasayed@msa.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer assistant at pediatric dentistry department- faculty of dentistry- October University for Modern Sciences and Arts -

Study Record Dates

First Submitted

January 25, 2026

First Posted

February 2, 2026

Study Start

January 30, 2026

Primary Completion

February 25, 2026

Study Completion

March 15, 2026

Last Updated

February 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Locations

EG(1)