CariesPhase 4NCT02953886

The Effect of Silver Diamine Fluoride (SDF) on Bacteria Involved in Root or Cervical Carious Lesions

A Phase 4 study testing Silver Diamine Fluoride (SDF) in people with Caries, run by Heba Mitwalli at 1 site in United States.

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 study will compare bacteria levels in cavities before and after silver diamine fluoride (SDF) treatment. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Caries
What is being tested?: Silver Diamine Fluoride (SDF)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: Nov 2016to 20 Apr 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Generally healthy adult participants 18 years of age and older.
At least one tooth with active (soft) cavitated lesions of ICDAS score 5 or 6 near the gingival margin (coronal cervical caries at the CEJ or exposed root surfaces with soft active carious lesions exposing dentin).

Who cannot join

Adult participants who suffer from serious life-threatening medical diseases that interfere with basic daily self care activities.
Patients taking antibiotics within the last two weeks.
Patients using chlorhexidine or fluoride mouth washes within the last two weeks.
Pregnant or breastfeeding women.
Teeth with arrested (hard) cervical or root caries lesions.
Teeth that have been diagnosed with an abscess or an irreversible pulpitis, or are mobile.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: The Effect of Silver Diamine Fluoride (SDF) on Bacteria Involved in Root or Cervical Carious Lesions Using HOMINGS Technology. A Clinical Study

The study will compare bacteria levels in cavities before and after silver diamine fluoride (SDF) treatment.

Read the detailed description

To assess the effect of silver diamine fluoride (SDF) treatment on microorganisms present in root caries or cervical lesions by collecting microbial deposits before and 1 month after SDF application. Bacterial samples will be collected from 20 adult subjects at the initial visit before application of SDF and one month after. At the 1 month recall, examination for caries arrest will be performed. All 40 bacterial samples will be sent to the Forsyth Institute to verify bacterial composition using HOMINGS technology.

Conditions: Caries
Being tested: Silver Diamine Fluoride (SDF)
Keywords: Caries, Cavity, Silver Diamine Fluoride (SDF), HOMINGS

What participants receive

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

Silver Diamine Fluoride (SDF)Device
Also called Silver Dental Arrest
No caries removal will take place. Bacterial samples will be collected using Gracey curettes at the initial visit before application of SDF and one month after. The tooth will be dried and SDF will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet

Study groups in NCT02953886
Study group	Role	What they receive
Silver Diamine Fluoride (SDF)	Experimental	Application of Silver Diamine Fluoride (SDF) to root or cervical carious lesions (cavities). Collection of plaque pre- and one month post-SDF application. Receives: Device: Silver Diamine Fluoride (SDF)

What is being measured

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

Change in Bacterial Composition Before and One Month After SDF Application to Root or Cervical Caries Lesions
Using human oral microbiome identification using next-generation sequencing (HOMINGS), change in the total bacterial composition of all subjects was measured by the difference of the number of bacteria count from baseline to one month after SDF application.
Measured: baseline, One month after SDF
Caries Arrest of Teeth Measured by Change in Dentin Texture (Soft, Hard)
Caries were examined for hardness or softness before and after SDF application. The change in the texture was examined after one month of SDF application the change from soft to hard is noted below.
Measured: One month

Secondary outcomes (1)

Patient Assessment of Appearance of Treated Tooth (Concern With the Appearance of Study Tooth, Desire for the Study Tooth to be Filled)
Each subject was asked if they were concerned with the appearance of the tooth that SDF was applied too. They were also asked if they wanted the study tooth to be filled with a tooth color filling.
Measured: One month

Timeline

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

Nov 201620 Apr 2017

First posted3 Nov 2016 (estimated)
Study startNov 2016
Primary completion20 Apr 2017
Study completion20 Apr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CariesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02953886
Sponsor's protocol ID: HUM00117560
Status last verified: Sep 2018
First submitted: 27 Oct 2016
Last updated: 28 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Caries trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Silver Diamine Fluoride (SDF) on Bacteria Involved in Root or Cervical Carious Lesions Using HOMINGS Technology. A Clinical Study
ClinicalTrials.gov ID: NCT02953886
Acronym / sponsor ID: HUM00117560
Conditions: Caries
Keywords: Caries, Cavity, Silver Diamine Fluoride (SDF), HOMINGS
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Heba MitwalliUniversity, hospital or other
Collaborators: The Forsyth Institute
Study start: Nov 2016
Primary completion: 20 Apr 2017 (actual)
Study completion: 20 Apr 2017 (actual)
First posted: 3 Nov 2016 (estimated)
Results: Posted 25 Jun 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study will compare bacteria levels in cavities before and after silver diamine fluoride (SDF) treatment.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Silver Diamine Fluoride (SDF)	Experimental	Device: Silver Diamine Fluoride (SDF)Application of Silver Diamine Fluoride (SDF) to root or cervical carious lesions (cavities). Collection of plaque pre- and one month post-SDF application.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Generally healthy adult participants 18 years of age and older.
At least one tooth with active (soft) cavitated lesions of ICDAS score 5 or 6 near the gingival margin (coronal cervical caries at the CEJ or exposed root surfaces with soft active carious lesions exposing dentin).

Key exclusion criteria (6 listed)

Adult participants who suffer from serious life-threatening medical diseases that interfere with basic daily self care activities.
Patients taking antibiotics within the last two weeks.
Patients using chlorhexidine or fluoride mouth washes within the last two weeks.
Pregnant or breastfeeding women.
Teeth with arrested (hard) cervical or root caries lesions.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Silver Diamine Fluoride (SDF)Also: Silver Dental ArrestNo caries removal will take place. Bacterial samples will be collected using Gracey curettes at the initial visit before application of SDF and one month after. The tooth will be dried and SDF will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet	Device	Silver Diamine Fluoride (SDF)

Primary outcome

Change in Bacterial Composition Before and One Month After SDF Application to Root or Cervical Caries Lesions
Time frame: baseline, One month after SDF
Using human oral microbiome identification using next-generation sequencing (HOMINGS), change in the total bacterial composition of all subjects was measured by the difference of the number of bacteria count from baseline to one month after SDF application.
Caries Arrest of Teeth Measured by Change in Dentin Texture (Soft, Hard)
Time frame: One month
Caries were examined for hardness or softness before and after SDF application. The change in the texture was examined after one month of SDF application the change from soft to hard is noted below.

1 secondary outcome

Patient Assessment of Appearance of Treated Tooth (Concern With the Appearance of Study Tooth, Desire for the Study Tooth to be Filled)
Time frame: One month

Results and safety

Results posted to the registry on 25 Jun 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Silver Diamine Fluoride (SDF)	20	20

Primary outcome: Change in Bacterial Composition Before and One Month After SDF Application to Root or Cervical Caries Lesions

Time frame: baseline, One month after SDF. Number. Unit: bacterial count

Measure	Silver Diamine Fluoride (SDF) n = 20
Baseline	1890087
One month after SDF	1959306

Primary outcome: Caries Arrest of Teeth Measured by Change in Dentin Texture (Soft, Hard)

Time frame: One month. Number. Unit: cervical lesions

Measure	Silver Diamine Fluoride (SDF) n = 20
Soft	8
Hard	12

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 7 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Silver Diamine Fluoride (SDF)	0 of 21 (0%)	21 of 21 (100%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Caries

Active, not recruiting
Trial With Two New Tooth-colored Restorative Materials in Class I/II Cavities
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Not yet recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Heba Mitwalli, DDS principal investigator

University of Michigan

Margherita Fontana, DDS, PhD study chair

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Silver Diamine Fluoride (SDF) in people with Caries, run by Heba Mitwalli at 1 site in United States.

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 2 inclusion and 6 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 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Bacterial Composition Before and One Month After SDF Application to Root or Cervical Caries Lesions (time frame: baseline, One month after SDF). The study lists 2 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 NCT02953886.

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 28 Sep 2018.