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
About this trial
This is an interventional treatment trial for Root Caries
Eligibility Criteria
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
NCT ID
NCT04370080
First Posted
April 23, 2020
Last Updated
April 29, 2020
Sponsor
Roseman University of Health Sciences
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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