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Fluoride Treatment

Silver Diamine Fluoride for Tooth Decay

N/A

Recruiting

Led By Richard Niederman, DMD

Research Sponsored by NYU College of Dentistry

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two years

Awards & highlights

Study Summary

This trial will compare the benefits of two interventions to prevent tooth decay in children.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ five years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~five years

This trial's timeline: 3 weeks for screening, Varies for treatment, and five years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Arrest of dental caries assessed based on a clinical oral examination

Caries prevention

Side effects data

From 2020 Phase 3 trial • 98 Patients • NCT02601833

45%

Active (soft) Lesion

13%

Active (soft) Lesion with Progression

Radiographic signs of periapical infection

Reversible Pulpitis

Extraction

Hard (arrested) Lesion with Progression

100%

80%

60%

40%

20%

Study treatment Arm

Silver Diamine Fluoride

Conventional Caries Management

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Simple PreventionExperimental Treatment2 Interventions

One drop (0.05 ml) of silver diamine fluoride (Advantage ArrestTM) solution at 38% concentration (2.24 F-ion mg/dose) will be dispensed per child. Posterior tooth surfaces to be treated will be dried, after which the SDF will be applied with a micro-brush to all asymptomatic carious lesions and to all pits and fissures on bicuspids and molar teeth for thirty seconds. Fluoride varnishes (5% NaF) will then be applied to all teeth. Dosage frequency will be twice-yearly.

Group II: Complex PreventionActive Control2 Interventions

Pits and fissures on all bicuspids and molar teeth will be sealed with glass ionomer sealants (GC Fuji IX). Glass ionomer sealants (interim therapeutic restorations) will also be placed on all frank asymptomatic carious lesions. Fluoride varnishes (5% NaF) will then be applied to all teeth. Dosage frequency will be twice-yearly.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Silver Diamine Fluoride

2019

Completed Phase 3

~8880

Fluoride Varnishes

2019

N/A

~7420

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

NYU College of DentistryLead Sponsor

11 Previous Clinical Trials

9,002 Total Patients Enrolled

National Institute on Minority Health and Health Disparities (NIMHD)NIH

384 Previous Clinical Trials

1,212,508 Total Patients Enrolled

Richard Niederman, DMDPrincipal Investigator - NYU Langone Health

NYU College of Dentistry

1 Previous Clinical Trials

7,418 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who can register for participation in this research?

"This experiment requires 3960 individuals aged between five to twelve who have dental caries as a condition."

Answered by AI

Does this research program allow for geriatric individuals to participate?

"As prescribed in the enrollment criteria, this trial is open to children aged between 5 and 12 years old."

Answered by AI

How many research participants are currently involved in this investigation?

"Affirmative, the information found on clinicaltrials.gov indicates that enrollment is currently ongoing for this trial which was first published on September 20, 2017 and most recently updated 29th of September 2022. A total of 3960 participants are being sought from a single site."

Answered by AI

Are they currently recruiting individuals to participate in this clinical investigation?

"Correct. As displayed on clinicaltrials.gov, this research is proactively looking for 3960 patients at 1 location and was first advertised in 2017 with its latest update occurring in 2022."

Answered by AI

Recent research and studies

BMJ OpenJournal

Comparative Effectiveness of Treatments to Prevent Dental Caries Given to Rural Children in School-based Settings: Protocol for a Cluster Randomised Controlled Trial

Ruff, Ryan Richard, and Richard Niederman. 2018. “Comparative Effectiveness of Treatments to Prevent Dental Caries Given to Rural Children in School-based Settings: Protocol for a Cluster Randomised Controlled Trial”. BMJ Open. BMJ. doi:10.1136/bmjopen-2018-022646.

clinicaltrials.govStudy

Comparative Effectiveness of Treatments to Prevent Dental Caries

Richard Niederman 2017. "Comparative Effectiveness of Treatments to Prevent Dental Caries". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03448107.