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Trial record 4 of 288 for:    Sodium Fluoride OR Duraphat

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

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ClinicalTrials.gov Identifier: NCT03089567
Recruitment Status : Unknown
Verified March 2017 by Yale University.
Recruitment status was:  Not yet recruiting
First Posted : March 24, 2017
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
Yale University

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

Condition or disease Intervention/treatment Phase
Dental Caries Drug: Sodium Fluoride Drug: Silver diamine fluoride Early Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : June 15, 2017
Estimated Primary Completion Date : June 15, 2018
Estimated Study Completion Date : July 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
No Intervention: CONTROL GROUP
Patients waiting for treatment under general Anesthesia without any intervention
Active Comparator: Sodium Fluoride Varnish
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
5% Sodium Fluoride Varnish used for dental caries prevention and desensitizer
Other Name: Duraflor

Experimental: Silver Diamine Fluoride
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
38% Silver Diamine Fluoride used for dental caries prevention and desensitizer
Other Name: Advantage Arrest




Primary Outcome Measures :
  1. Salivary levels of Streptococcus mutans [ Time Frame: Baseline ]
    Salivary samples will be obtained with Children's Swab (SalivaBio) and S. Mutans level will be measured using Saliva-Check Mutans (GC America)

  2. Salivary levels of Streptococcus mutans [ Time Frame: 1 month ]
    Salivary samples will be obtained with Children's Swab (SalivaBio) and S. Mutans level will be measured using Saliva-Check Mutans (GC America)

  3. Salivary levels of Streptococcus mutans [ Time Frame: 3 months ]
    Salivary samples will be obtained with Children's Swab (SalivaBio) and S. Mutans level will be measured using Saliva-Check Mutans (GC America)

  4. Salivary levels of Streptococcus mutans [ Time Frame: 6 months ]
    Salivary samples will be obtained with Children's Swab (SalivaBio) and S. Mutans level will be measured using Saliva-Check Mutans (GC America)



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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ASA I without prior history of dental restorations

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03089567


Contacts
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Contact: Michael Pawlowski, DMD 203-688 ext 3000 mjpawlowski822@gmail.com
Contact: Swapnil Mahendrakar, DMD 940-231 0469 swapnil.mahendrakar@ynhh.org

Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Eunice Lee, DMD Yale New Haven Hospital
Principal Investigator: Christel Haberland, DDS Yale New Haven Hospital

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03089567     History of Changes
Other Study ID Numbers: SMAHEN
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Yale University:
Silver diamine Fluoride
Streptococcus mutans
Caries prevention
Fluoride

Additional relevant MeSH terms:
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Fluorides
Sodium Fluoride
Fluorides, Topical
Listerine
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents