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Silver Diamine Fluoride Treatment of Active Root Caries Lesions in Older Adults: A Case Series

Primary Purpose

Root Caries

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Silver Diamine Fluoride 38%
Sponsored by
Roseman University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Root Caries

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • At least 1 active root surface caries lesion by Nyvad criteria

Exclusion Criteria:

  • None

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Silver Diamine Fluoride

    Arm Description

    Topical application of one drop of silver diamine fluoride 38% to active untreated roof surface caries, lesions at the furcation, or lesions at crown margins. Application was repeated once each six months.

    Outcomes

    Primary Outcome Measures

    Dental caries lesion activity 1
    Nyvad score based on visual/tactile examination
    Dental caries lesion activity 2
    Nyvad score based on visual/tactile examination
    Dental caries lesion activity 3
    Nyvad score based on visual/tactile examination
    Dental caries lesion activity 4
    Nyvad score based on visual/tactile examination
    Dental caries lesion activity 5
    Nyvad score based on visual/tactile examination

    Secondary Outcome Measures

    Caries lesion fluorescence 1
    Laser fluorescence measurement at the surface of the lesion
    Caries lesion fluorescence 2
    Laser fluorescence measurement at the surface of the lesion
    Caries lesion fluorescence 3
    Laser fluorescence measurement at the surface of the lesion
    Caries lesion fluorescence 4
    Laser fluorescence measurement at the surface of the lesion
    Caries lesion fluorescence 5
    Laser fluorescence measurement at the surface of the lesion

    Full Information

    First Posted
    April 23, 2020
    Last Updated
    April 29, 2020
    Sponsor
    Roseman University of Health Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04370080
    Brief Title
    Silver Diamine Fluoride Treatment of Active Root Caries Lesions in Older Adults: A Case Series
    Official Title
    Silver Diamine Fluoride Treatment of Active Root Caries Lesions in Older Adults: A Case Series
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 3, 2017 (Actual)
    Primary Completion Date
    November 21, 2019 (Actual)
    Study Completion Date
    November 21, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Roseman University of Health Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The authors conducted a case series to determine the outcomes of treatment of root surface caries lesions when the teeth were treated topically with 38% silver diamine fluoride.
    Detailed Description
    The study is a prospective, single center case series. The cases were consecutive. Participation was offered to every patient who qualified based on age and the presence of an active lesion in a root surfaces, in a furcation, or under an individual crown or crown abutment for a fixed prosthesis. The study was conducted at the dental clinic of the Roseman College of Dental Medicine in South Jordan, Utah. The University of California, San Francisco protocol for applying topical silver diamine fluoride was adapted for use with these patients. Lesions were flushed with water and then dried with compressed air, isolated with cotton rolls, and then 38% silver diamine fluoride (Advantage Arrest, Elevate Oral Care, West Palm Beach, FL) was applied repeatedly for two minutes with the manufacturer supplied dental applicator. The silver diamine fluoride was stored under the manufacturer's recommended conditions. If the patient complained about the taste, the lesion was coated with sodium fluoride varnish. All of the lesions were reevaluated for dental caries lesion activity about every six months and retreated regardless of their arrest status. Follow-up was for 30 months or until loss to follow-up.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Root Caries

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Case series, consecutive
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    63 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Silver Diamine Fluoride
    Arm Type
    Experimental
    Arm Description
    Topical application of one drop of silver diamine fluoride 38% to active untreated roof surface caries, lesions at the furcation, or lesions at crown margins. Application was repeated once each six months.
    Intervention Type
    Device
    Intervention Name(s)
    Silver Diamine Fluoride 38%
    Other Intervention Name(s)
    Advantage Silver Arrest
    Intervention Description
    Dental caries arrest medication
    Primary Outcome Measure Information:
    Title
    Dental caries lesion activity 1
    Description
    Nyvad score based on visual/tactile examination
    Time Frame
    6-12 months
    Title
    Dental caries lesion activity 2
    Description
    Nyvad score based on visual/tactile examination
    Time Frame
    <6 months
    Title
    Dental caries lesion activity 3
    Description
    Nyvad score based on visual/tactile examination
    Time Frame
    12-18 months
    Title
    Dental caries lesion activity 4
    Description
    Nyvad score based on visual/tactile examination
    Time Frame
    18-24 months
    Title
    Dental caries lesion activity 5
    Description
    Nyvad score based on visual/tactile examination
    Time Frame
    24-30 months
    Secondary Outcome Measure Information:
    Title
    Caries lesion fluorescence 1
    Description
    Laser fluorescence measurement at the surface of the lesion
    Time Frame
    <6 months
    Title
    Caries lesion fluorescence 2
    Description
    Laser fluorescence measurement at the surface of the lesion
    Time Frame
    6-12 months
    Title
    Caries lesion fluorescence 3
    Description
    Laser fluorescence measurement at the surface of the lesion
    Time Frame
    12-18 months
    Title
    Caries lesion fluorescence 4
    Description
    Laser fluorescence measurement at the surface of the lesion
    Time Frame
    18-24 months
    Title
    Caries lesion fluorescence 5
    Description
    Laser fluorescence measurement at the surface of the lesion
    Time Frame
    24-30 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: At least 1 active root surface caries lesion by Nyvad criteria Exclusion Criteria: None
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David Prince, DDS
    Organizational Affiliation
    Roseman Health Sciences University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    10343087
    Citation
    Nyvad B, Machiulskiene V, Baelum V. Reliability of a new caries diagnostic system differentiating between active and inactive caries lesions. Caries Res. 1999 Jul-Aug;33(4):252-60. doi: 10.1159/000016526.
    Results Reference
    background
    PubMed Identifier
    33347946
    Citation
    Mitchell C, Gross AJ, Milgrom P, Mancl L, Prince DB. Silver diamine fluoride treatment of active root caries lesions in older adults: A case series. J Dent. 2021 Feb;105:103561. doi: 10.1016/j.jdent.2020.103561. Epub 2020 Dec 24.
    Results Reference
    derived

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    Silver Diamine Fluoride Treatment of Active Root Caries Lesions in Older Adults: A Case Series

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