ClinicalTrials.gg
CompletedNCT04370080Updated Apr 30, 2020

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

An interventional study of Silver Diamine Fluoride 38% in Root Caries, sponsored by Roseman University of Health Sciences. Completed. Open to participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-30.

Sponsored by Roseman University of Health Sciences · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 3 months after the study started (first participant enrolled Jan 2017, registered Apr 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Not applicable
Ages
55 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Root Caries

Browse trials for

03

In context

Root Caries

39 studies on the registry are indexed under Root Caries; 14 are open to participants now.

This study's enrollment of 63 is close to the median of 62 across 35 interventional studies indexed under Root Caries.

Browse Root Caries studies →

Lead sponsor

Roseman University of Health Sciences is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    Silver Diamine Fluoride

    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.

    Device: Silver Diamine Fluoride 38%

Interventions

  • DeviceSilver Diamine Fluoride 38%

    Dental caries arrest medication

    Also known as: Advantage Silver Arrest

06

What researchers measure

Primary outcomes

  1. Dental caries lesion activity 1

    Nyvad score based on visual/tactile examination

    Time frame: 6-12 months

  2. Dental caries lesion activity 2

    Nyvad score based on visual/tactile examination

    Time frame: <6 months

  3. Dental caries lesion activity 3

    Nyvad score based on visual/tactile examination

    Time frame: 12-18 months

  4. Dental caries lesion activity 4

    Nyvad score based on visual/tactile examination

    Time frame: 18-24 months

  5. Dental caries lesion activity 5

    Nyvad score based on visual/tactile examination

    Time frame: 24-30 months

Secondary outcomes

  1. Caries lesion fluorescence 1

    Laser fluorescence measurement at the surface of the lesion

    Time frame: <6 months

  2. Caries lesion fluorescence 2

    Laser fluorescence measurement at the surface of the lesion

    Time frame: 6-12 months

  3. Caries lesion fluorescence 3

    Laser fluorescence measurement at the surface of the lesion

    Time frame: 12-18 months

  4. Caries lesion fluorescence 4

    Laser fluorescence measurement at the surface of the lesion

    Time frame: 18-24 months

  5. Caries lesion fluorescence 5

    Laser fluorescence measurement at the surface of the lesion

    Time frame: 24-30 months

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2017 to primary completion in Nov 2019, 34 months.

Of 21 interventional studies with no phase under Root Caries, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 55. This study's 34 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 23, 2020
First posted
Apr 30, 2020
StartActual
Jan 3, 2017
Primary completionActual
Nov 21, 2019
CompletionActual
Nov 21, 2019
Last update
Apr 30, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04370080
Lead sponsor
Roseman University of Health Sciences
Responsible party
David Prince (Associate Professor, Roseman University of Health Sciences) — Principal investigator
First posted
Apr 30, 2020
Start date
Jan 3, 2017
Primary completion
Nov 21, 2019
Completion
Nov 21, 2019
Last update
Apr 30, 2020

Study contacts

David Prince, DDS
principal investigator · Roseman Health Sciences University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion