NCT05642494 is a Phase 3 clinical trial of SDF in Early Childhood Caries, sponsored by Alexandria University.

Who is sponsoring NCT05642494?

NCT05642494 is sponsored by Alexandria University.

What drugs are being tested in NCT05642494?

Interventions in NCT05642494: SDF, NaF.

What condition does NCT05642494 study?

NCT05642494 studies Early Childhood Caries.

Is NCT05642494 still recruiting?

NCT05642494 is currently completed. Last updated 19 July 2023.

Last reviewed 2023-07-19 · How we verify

NCT05642494

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Silver Diamine Fluoride(SDF) Versus SDF Combined With Sodium Fluoride Varnish in the Arrest of Early Childhood Caries

Completed Phase 3 Last updated 19 July 2023

What this trial tests

Phase 3 trial testing SDF in Early Childhood Caries in 220 participants. Completed in 30 April 2023.

Timeline

1 March 2022

Primary endpoint
30 March 2023

30 April 2023

Quick facts

Lead sponsor	Alexandria University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	220
Start date	1 March 2022
Primary completion	30 March 2023
Estimated completion	30 April 2023
Sites	1 location across Egypt

Drugs / interventions tested

SDF — full drug profile →
NaF — full drug profile →

Conditions studied

Early Childhood Caries — all drugs for Early Childhood Caries →

Sponsor

Alexandria University

Who can join

Adults 1 to 4, any sex, with Early Childhood Caries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Early childhood caries (ECC) is the most common chronic childhood disease worldwide. Early restorative intervention may treat the disease but this is often difficult especially with uncooperative children so it may be left untreated. Remineralization of affected dentin using silver diamine fluoride (SDF) can arrest these lesions. This trial aims to compare the effectiveness of 38% SDF solution versus 38% SDF solution with 5% sodium fluoride (NaF) varnish after six months in arresting ECC lesions.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Silver diamine fluoride with sodium fluoride varnish versus silver diamine fluoride in arresting early childhood caries: a 6-months follow up of a randomized field trial.
Abdellatif EB, El Kashlan MK, El Tantawi M. · · 2023 · cited 13× · PMID 37978488 · DOI 10.1186/s12903-023-03597-5
Silver Diamine Fluoride with Sodium Fluoride Varnish versus Silver Diamine Fluoride in arresting early childhood caries: A randomized field trial
Abdellatif E, Tantawi ME, Elkashlan MK. · · 2023 · DOI 10.21203/rs.3.rs-3083824/v1

Verify or expand the search:

Other trials of SDF

Trials testing the same drug.

NCT05964387 — Effect of Silver Diamine Fluoride on Local Anesthesia in Hypomineralized Molars · NA · recruiting
NCT05392868 — Managing Dentine Hypersensitivity With Silver Diamine Fluoride on Older Adults · Phase 2 · unknown
NCT05761041 — Silver Diamine Fluoride Versus Sodium Fluoride Varnish With Parental Behavior Modification in Arresting Early Childhood · Phase 3 · completed
NCT05748067 — Minimally Invasive Treatment for Permanent Molars Affected With Molar-incisor Hypomineralization Defects · NA · completed
NCT04765904 — Clinical Efficiency and Treatment Failure of Hall Versus SDF Techniques in the Management of Carious Primary Molar. · NA · unknown

Other recruiting trials for Early Childhood Caries

Currently open trials in the same condition.

NCT05761197 — Oropharyngeal Candidiasis (OPC) and S-ECC · recruiting
NCT06441500 — Oral Health and Dental Caries Prevention Intervention for Children in Romania · NA · recruiting
NCT06241261 — Arresting Early Childhood Caries With a Silver Diamine Fluoride Gel · Phase 2 · active not recruiting
NCT05716867 — Salivary Cystatin S Levels in a Group of Egyptian Children · active not recruiting

Other Alexandria University trials

Trials by the same sponsor.

NCT07517861 — Integrated Mental Health Nursing Program: Effects on Stigma, Cognitive Flexibility, and Clinical Readiness · NA · recruiting
NCT07476482 — The Impact of a Shared Decision-Making Intervention on Intraoperative Patient Experience During Elective Cesarean Delive · NA · enrolling by invitation
NCT07476209 — Sialendoscopy Versus Photobiomodulation in Prevention of Radiation Induced Xerostomia · NA · recruiting
NCT07503626 — Optimization of Orthodontic Bracket Placement by Using Two Different Protocols of Digitally Aided Bonding · NA · recruiting
NCT07522944 — AI-Guided Relaxation for Hemodialysis Anxiety · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05642494 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Alexandria University
Last refreshed: 19 July 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05642494.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing