Silver Diamine Fluoride Gel: Case Series (KiruPoderoso)

January 29, 2024 updated by: Advantage Silver Dental Arrest, LLC

Evaluation of the Response of Caries Lesions in Dentin After Application of Silver Diamine Fluoride Gel: A Case Series

A clinical case series to determine the clinical response of dental caries lesions in primary teeth where 38% silver diamine fluoride gel is applied and cover with 2.5% sodium fluoride varnish. Additionally, to assess parent satisfaction with treatment with 38% silver diamine fluoride.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A clinical case series of 235 children ages 3 and 4 with severe early childhood caries where the lesions are treated with 38% silver diamine fluoride and covered with 2.5% sodium fluoride varnish at baseline and 6 months. The primary objective is to determine the response of dental caries lesions (caries arrest) into the dentin in primary teeth at one year of follow-up. The secondary objective is to assess parent satisfaction with treatment with 38% silver diamine fluoride and 2.5% sodium fluoride varnish.

Study Type

Observational

Enrollment (Actual)

235

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Peru
      • Puno, Peru
        • UGEL Manazo
      • Puno, Peru
        • UGEL Puno 210001 Las Torres
      • Puno, Peru
        • UGEL Puno Magisterial
      • Puno, Peru
        • UGEL San Jose
      • Puno, Peru
        • UGEL Villa del Lago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 4 years (Child)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The children will be recruited from five schools (Centro Educativo Inicial) in Puno, Peru

Description

Inclusion Criteria:

  • At least one active caries lesion Good general health by parent report

Exclusion Criteria:

  • Unable to cooperate with exam or procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SDF/FV
Topical Application of 38% silver diamine fluoride and 2.5% sodium fluoride varnish at baseline and 6 months
Device: Silver Diamine Fluoride/Sodium Fluoride Varnish
Application of dental caries arresting topical medication
Other Names:
  • Advantage Silver Dental Arrest 38% Gel
  • Fluorimax 2.5% Sodium Fluoride Varnish

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lesion Activity
Time Frame: 5 months
Caries Lesion Arrest
5 months
Lesion Activity
Time Frame: 12 months
Caries Lesion Arrest
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caries Increment
Time Frame: 5 months
Caries Increment (d2-4mfs)
5 months
Caries Increment
Time Frame: 12 months
Caries Increment (d2-4mfs)
12 months
New Caries Lesions
Time Frame: 5 months
Rate of New Caries Lesions ((d2-4mfs)
5 months
New Caries Lesions
Time Frame: 12 months
Rate of New Caries Lesions ((d2-4mfs)
12 months
Satisfaction with Color Changes in Teeth
Time Frame: 5 months
Bothered by Color Changes in the teeth (1-10 scale)
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advantage Silver Dental Arrest, LLC

Collaborators

University of Washington
Universidad Nacional Del Altiplano Puno

Investigators

  • Principal Investigator: Taina Padilla Caceres, DDS, Universidad Nacional del Altiplano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2022

Primary Completion (Actual)

July 17, 2023

Study Completion (Actual)

January 29, 2024

Study Registration Dates

First Submitted

May 24, 2022

First Submitted That Met QC Criteria

May 24, 2022

First Posted (Actual)

May 27, 2022

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gel 2022-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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