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Completed

NCT Number: NCT02536040

Stopping Cavities Study: Diammine Silver Fluoride

This study is being conducted to test whether the use of diammine silver fluoride (also called silver diamine fluoride) hardens the cavity sufficiently so that it arrests.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

24 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Advantage Dental Plans

Redmond, Oregon, 97756, United States

About this study

Phase III RCT with two arms: (1) 38% diammine silver fluoride; (2) distilled fluoride free water. Subjects are 200 preschool children in good general health with untreated tooth decay. Intervention is topical application of the study drug to the open cavity. Primary outcome is caries activity at 14-21 days.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Nyvad criteria 3
  • Active carious lesion

Exclusion criteria

  • Allergy to silver
  • Stomatitis or oral ulcerative condition
  • Weight less than 15 kg

Treatment and study plan

38% diammine silver fluoride

Drug

treatment of cavity with study agent

Other names: silver fluoride, silver diamine fluoride

Water

Other

Fluoride free, distilled water

Primary outcomes

  1. Dental Caries Activity

    Time frame: 14-21 days

    Proportion of treated teeth with active decay that were arrested by the treatment measured using the Nyvad criterion code 6 reflecting hardness of the lesion and color change

Sponsors and collaborators

Lead sponsor

Advantage Dental Services, LLC

Industry

Registry information

Official study title

Pragmatic Trial of Topical Diammine Silver Fluoride for Dental Caries Arrest

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 31, 2015
Registry last updated
Jan 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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