NCT03089567

Brief Summary

Comparison of the salivary levels of Streptococcus mutans in pediatric patients with Early Childhood Caries after the application of Silver Diamine Fluoride or 5% Sodium Fluoride Varnish

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2017

Shorter than P25 for early_phase_1

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 24, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

September 15, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2018

Completed
Last Updated

October 23, 2020

Status Verified

October 1, 2020

Enrollment Period

4 months

First QC Date

March 20, 2017

Last Update Submit

October 21, 2020

Conditions

Dental Caries

Keywords

Silver diamine FluorideStreptococcus mutansCaries preventionFluoride

Outcome Measures

Primary Outcomes (4)

  • Salivary levels of Streptococcus mutans

    Salivary samples will be obtained with Children's Swab (SalivaBio) and S. Mutans level will be measured using Saliva-Check Mutans (GC America)

    Baseline

  • Salivary levels of Streptococcus mutans

    Salivary samples will be obtained with Children's Swab (SalivaBio) and S. Mutans level will be measured using Saliva-Check Mutans (GC America)

    1 month

  • Salivary levels of Streptococcus mutans

    Salivary samples will be obtained with Children's Swab (SalivaBio) and S. Mutans level will be measured using Saliva-Check Mutans (GC America)

    3 months

  • Salivary levels of Streptococcus mutans

    Salivary samples will be obtained with Children's Swab (SalivaBio) and S. Mutans level will be measured using Saliva-Check Mutans (GC America)

    6 months

Study Arms (3)

CONTROL GROUP

NO INTERVENTION

Patients waiting for treatment under general Anesthesia without any intervention

Sodium Fluoride Varnish

ACTIVE COMPARATOR

Sodium Fluoride Varnish will be applied at 0,1,3 months Follow ups while waiting to receive dental treatment under general anesthesia

Drug: Sodium Fluoride

Silver Diamine Fluoride

EXPERIMENTAL

Silver Diamine Fluoride will be applied at 0,1,3 months Follow ups while waiting to receive dental treatment under general anesthesia

Drug: Silver diamine fluoride

Interventions

Sodium FluorideDRUG

5% Sodium Fluoride Varnish used for dental caries prevention and desensitizer

Also known as: Duraflor
Sodium Fluoride Varnish
Silver diamine fluorideDRUG

38% Silver Diamine Fluoride used for dental caries prevention and desensitizer

Also known as: Advantage Arrest
Silver Diamine Fluoride

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • ASA I without prior history of dental restorations

You may not qualify if:

  • Patient with: special healthcare needs, xerostomia, complicated medical history (ASA II-VI)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dental Caries

Interventions

Sodium FluorideDuraflorsilver diamine fluoride

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

FluoridesHydrofluoric AcidFluorine CompoundsInorganic ChemicalsSodium CompoundsCariostatic AgentsBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Eunice Lee, DMD

    Yale New Haven Hospital

    PRINCIPAL INVESTIGATOR

  • Christel Haberland, DDS

    Yale New Haven Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2017

First Posted

March 24, 2017

Study Start

September 15, 2017

Primary Completion

January 15, 2018

Study Completion

January 15, 2018

Last Updated

October 23, 2020

Record last verified: 2020-10