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CompletedNCT05761041Updated Jul 20, 2023

Silver Diamine Fluoride Versus Sodium Fluoride Varnish With Parental Behavior Modification in Arresting Early Childhood Caries

A Phase 3 interventional study of Sodium Fluoride Varnish (5%) and Motivational Interviewing in Early Childhood Caries, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 1 Year to 4 Years. Per ClinicalTrials.gov, last updated 2023-07-20.

Sponsored by Alexandria University · Phase 3, Interventional, and Prevention

From the registry’s dates

  • Primary completion was Mar 2023, 3 years 6 months ago, and no results have been posted to the registry.
  • Registered 10 months after the study started (first participant enrolled Mar 2022, registered Feb 2023).
Phase
Phase 3
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
1 Year to 4 Years
Sex
All
01

Study summary

Arresting dental caries using silver diamine fluoride (SDF) has gained attention recently for the management of early childhood caries (ECC). However, black staining is one of its drawbacks. A possible affordable alternative can be Sodium Fluoride (NaF) supported with good oral hygiene induced by parental Motivational Interviewing (MI).

The trial aims to compare the impact of SDF versus NaF supported by MI on lesion activity in preschool children.

02

Conditions studied

  • Early Childhood Caries

Keywords

  • ECC
  • 38% SDF
  • 5% NaF
  • Motivational Interviewing
  • Preschoolers
03

In context

Lead sponsor

Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 4 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Children aged ≤ 4 years old.
  2. The presence of at least one active carious lesion on a primary tooth, with scores 3 and higher (according to the International Detection and Assessment System- ICDAS II)
  3. Children whose caregivers have means of communication (mobile phones).
  4. Completion of an informed consent to participate in the study.

Exclusion criteria

Exclusion Criteria:

  1. Children reporting spontaneous or elicited pain from caries or showing any signs of pulpal infection, swelling and/or abscess.
  2. Parental refusal to participate in the study.
  3. Allergy or sensitivity to silver or any of the materials included in the study.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
140 participants (actual)

Study arms

  • Experimental
    Naf + MI

    Sodium Fluoride Varnish 5% (Applied biannually) + two MI sessions: baseline face-to-face session and phone call after 3months.

    Drug: Sodium Fluoride Varnish (5%) · Behavioral: Motivational Interviewing

  • Active comparator
    SDF

    Silver Diamine fluoride 38% (Applied biannually)

    Drug: SDF

Interventions

  • DrugSodium Fluoride Varnish (5%)

    Applied at baseline

  • BehavioralMotivational Interviewing

    Two MI sessions: face-to-face at baseline and phone call at 3 months

  • DrugSDF

    Applied bianually

06

What researchers measure

Primary outcomes

  1. Caries Arrest

    Percentage of arrested carious lesions

    Time frame: 6 months

Secondary outcomes

  1. Caries Increment

    Number of new carious lesions will be assessed using decayed, missing (due to caries), and filled primary tooth surface index (dmfs)

    Time frame: 6 months

  2. Parental satisfaction

    Parents will be asked if application was an easy process, pain free for their child and taste is acceptable. Answers will be on a 5 point Likert scale (Strongly agree, Agree, Neutral , Disagree, Strongly disagree).

    Time frame: Baseline and 6 months

07

Study locations

1 site
  • Alexandria University
    Alexandria, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05761041
Lead sponsor
Alexandria University
Collaborators
Science, Technology & Innovation Funding Authority (STDF)
Responsible party
randa hassan abdelsamea yassin (Teaching Assistant, Alexandria University) — Principal investigator
First posted
Mar 9, 2023
Start date
Mar 28, 2022
Primary completion
Mar 30, 2023
Completion
Apr 15, 2023
Last update
Jul 20, 2023

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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