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NCT03770286

Treatment of Interproximal Cavities on Primary Molar Teeth With Silver Diamine Fluoride

Completed NA Results posted Last updated 15 October 2024
What this trial tests

NA trial testing 5% Fluoride Varnish in Dental Caries in Children in 51 participants. Completed in 31 May 2023.

Timeline
22 January 2019
Primary endpoint
31 May 2023
31 May 2023

Quick facts

Lead sponsorChildren's Hospital Los Angeles
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment51
Start date22 January 2019
Primary completion31 May 2023
Estimated completion31 May 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Children's Hospital Los Angeles

Who can join

Adults 3 to 12, any sex, with Dental Caries in Children or Dental Caries Class II. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Interproximal Caries Zone of Radiolucency Primary · Baseline to 6 months

Bitewing radiographs will be taken of target lesions at Day 1 (baseline). Target interproximal carious lesion(s) will be rated based on the zone of radiolucency on the radiographs using the International Caries Classification and Management System (ICCMS). Category 1 = Progression Category 2 = Stabilization Category 3 = Remineralization

Category 1 = Progression
GroupValue95% CI
Fluoride Varnish Alone9
SDF With Super Floss7
SDF Without Super Floss10
Category 2 = Stabilization
GroupValue95% CI
Fluoride Varnish Alone12
SDF With Super Floss31
SDF Without Super Floss22
Category 3 = Remineralization
GroupValue95% CI
Fluoride Varnish Alone10
SDF With Super Floss6
SDF Without Super Floss11
Interproximal Caries Zone of Radiolucency Primary · 6 months to 12 months

Bitewing radiographs will be taken of target lesions at 6 months and compared. Target interproximal carious lesion(s) will be rated based on the zone of radiolucency on the radiographs using the International Caries Classification and Management System (ICCMS). Category 1 = Progression Category 2 = Stabilization Category 3 = Remineralization

Category 1 = Progression
GroupValue95% CI
Fluoride Varnish Alone6
SDF With Super Floss3
SDF Without Super Floss9
Category 2 = Stabilization
GroupValue95% CI
Fluoride Varnish Alone3
SDF With Super Floss13
SDF Without Super Floss10
Category 3 = Remineralization
GroupValue95% CI
Fluoride Varnish Alone3
SDF With Super Floss3
SDF Without Super Floss2
Interproximal Caries Zone of Radiolucency Primary · Baseline to 12 months

Bitewing radiographs will be taken of target lesions at 12 months and compared. Target interproximal carious lesion(s) will be rated based on the zone of radiolucency on the radiographs using the International Caries Classification and Management System (ICCMS). Category 1 = Progression Category 2 = Stabilization Category 3 = Remineralization

Category 1 = Progression
GroupValue95% CI
Fluoride Varnish Alone8
SDF With Super Floss8
SDF Without Super Floss10
Category 2 = Stabilization
GroupValue95% CI
Fluoride Varnish Alone10
SDF With Super Floss20
SDF Without Super Floss13
Category 3 = Remineralization
GroupValue95% CI
Fluoride Varnish Alone6
SDF With Super Floss5
SDF Without Super Floss7

Sponsor's own description

This study investigates whether 1) Silver diamine fluoride (SDF) application using Super Floss can arrest and/or reverse initial interproximal caries on primary molars and 2) whether SDF applied with Super Floss is more effective in arresting or remineralizing initial interproximal lesion in comparison to SDF applied without Super Floss or fluoride varnish applied alone.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Topical silver diamine fluoride (SDF) for preventing and managing dental caries in children and adults.
    Worthington HV, Lewis SR, Glenny AM, Huang SS, et al · · 2024 · cited 8× · PMID 39508296 · DOI 10.1002/14651858.cd012718.pub2

Verify or expand the search:

Other recruiting trials for Dental Caries in Children

Currently open trials in the same condition.

Other Children's Hospital Los Angeles trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT03770286.

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