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Root CariesNCT04370080

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

A study testing Silver Diamine Fluoride 38% in people with Root Caries, run by Roseman University of Health Sciences.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 years and olderHealthy volunteers can take part
Conditions the study is for
Root Caries
What is being tested?
Silver Diamine Fluoride 38%
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
No sites listed yet
Study dates
3 Jan 2017to 21 Nov 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • None

About this study

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.

Read the 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.

Conditions
Root Caries
Being tested
Silver Diamine Fluoride 38%
Medical subject headings
Root Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Silver Diamine Fluoride 38%Device

    Also called Advantage Silver Arrest

    Dental caries arrest medication

Study groups in NCT04370080
Study groupRoleWhat they receive
Silver Diamine FluorideExperimentalTopical 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.
Receives: Device: Silver Diamine Fluoride 38%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dental caries lesion activity 1

    Nyvad score based on visual/tactile examination

    Measured: 6-12 months

  2. Dental caries lesion activity 2

    Nyvad score based on visual/tactile examination

    Measured: <6 months

  3. Dental caries lesion activity 3

    Nyvad score based on visual/tactile examination

    Measured: 12-18 months

  4. Dental caries lesion activity 4

    Nyvad score based on visual/tactile examination

    Measured: 18-24 months

  5. Dental caries lesion activity 5

    Nyvad score based on visual/tactile examination

    Measured: 24-30 months

Secondary outcomes (5)

  1. Caries lesion fluorescence 1

    Laser fluorescence measurement at the surface of the lesion

    Measured: <6 months

  2. Caries lesion fluorescence 2

    Laser fluorescence measurement at the surface of the lesion

    Measured: 6-12 months

  3. Caries lesion fluorescence 3

    Laser fluorescence measurement at the surface of the lesion

    Measured: 12-18 months

  4. Caries lesion fluorescence 4

    Laser fluorescence measurement at the surface of the lesion

    Measured: 18-24 months

  5. Caries lesion fluorescence 5

    Laser fluorescence measurement at the surface of the lesion

    Measured: 24-30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2020
  2. Study start3 Jan 2017
  3. Primary completion21 Nov 2019
  4. Study completion21 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Case series, consecutive
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04370080
Sponsor's protocol ID
1122117-4
Status last verified
Apr 2020
First submitted
23 Apr 2020
Last updated
30 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 10343087

  • 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.

    PubMed 33347946

Questions about this trial

What is this clinical trial studying?

A study testing Silver Diamine Fluoride 38% in people with Root Caries, run by Roseman University of Health Sciences.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dental caries lesion activity 1 (time frame: 6-12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04370080, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2020.

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