CariesPhase 3NCT02601833

Effectiveness of Silver Diamine Fluoride as a Treatment for Caries in Comparison to Traditional Restorative Techniques

A Phase 3 study testing Silver Diamine Fluoride and Conventional Caries Management in people with Caries, run by University of Michigan at 2 sites 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 purpose of this study is to compare standard fillings and silver diamine fluoride (SDF) for treatment of cavities in baby teeth. The investigators will compare the effectiveness of stopping the cavity, cost of the treatments and the opinions of the families and the dental providers. Read more about this study

Who is it for?: Ages 2 to 10 years
Conditions the study is for: Caries
What is being tested?: Silver Diamine Fluoride and Conventional Caries Management
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 98 participants
Where: 2 sitesUnited States
Study dates: Jan 2016to 18 Sep 2020
Phase: Phase 3
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 2 to 10 years
All sexes
No healthy volunteers
Child

Who may be able to join

Presence of at least one active (soft) cavitated carious lesions in the primary dentition, extending into dentin (ICDAS 5 or 6)
The selected tooth must have a one or two surface lesion (more than 1/3 of the crown of the tooth must be remaining) and must allow for direct application of SDF
Study teeth will not have any spontaneous or elicited pain due to caries, tooth mobility, or signs of pulpal infection
Selected primary teeth must have an anticipated exfoliation date greater than 12 months away

Who cannot join

Hereditary developmental defects such as Amelogenesis Imperfecta and Dentinogenesis Imperfecta
Severe medical conditions that do not allow the child to be managed in the clinic
Known allergy /sensitivity to dental materials being used, including SDF
Inability of the child to cooperate for treatment, recall examinations, or periapical radiographs
Wards of the State, for consenting reasons

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109
Mott Children's Health Center
Flint, Michigan, 48503

Other trials in United States

About this study

Official title: The Effectiveness of Silver Diamine Fluoride as a Treatment for Caries in Comparison to Traditional Restorative Techniques: A 12 Month Randomized Controlled Trial

Read the detailed description

To determine the effectiveness of the application of silver diamine fluoride (SDF) in comparison to conventional restorative treatments in International Caries Detection and Assessment System criteria (ICDAS) 5 and 6, one and two surface carious lesions in primary molars which will be assessed based on major and minor failure criteria when followed for one year. Additionally, parents'/children's and providers' perceptions will be assessed as well as the cost of both regimens, to include both chair time spent and materials' costs.

Conditions: Caries
Being tested: Silver Diamine Fluoride, Conventional Caries Management
Keywords: Caries, Cavity

What participants receive

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

Silver Diamine FluorideDevice
Also called Silver Dental Arrest
No caries removal will take place. The tooth will be dried and Silver Diamine Fluoride will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet.
Conventional Caries ManagementProcedure or surgery
Also called Filling, Restoration
These children will receive restorative dental care in alignment with the American Academy of Pediatric Dentistry guidelines, within the confines of the Mott Children's Health Center clinic. This treatment typically includes administration of local anesthesia, placement of rubber dam, caries removal with rotary and hand instruments, and placement of a final restoration.

Study groups in NCT02601833
Study group	Role	What they receive
Silver Diamine Fluoride	Experimental	This arm will receive Silver Diamine Fluoride applied to their carious lesion, in lieu of restoration placement, with the goal of arresting caries. Receives: Device: Silver Diamine Fluoride
Conventional Caries Management	Active comparator	Restorative dental care according to American Academy of Pediatric Dentistry guidelines. This treatment typically includes administration of local anesthesia, placement of rubber dam, caries removal with rotary and hand instruments, and placement of a final restoration. Receives: Procedure: Conventional Caries Management

What is being measured

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

Caries Arrest of Teeth in the SDF Group Measured by Change in Size
Number of participants in the SDF arm that had an increase in lesion size at any point in the 12 months of the trial, as this is a treatment failure.
Treatment failures were assessed throughout the 12 month duration of the trial, and children with treatment failures were then removed from the trial for further clinical treatment.
Measured: 12 Months
Caries Arrest of Teeth in the SDF Group Measured by Dentin Color (Yellow, Brown, Black)
Color of the cavity at the end of the trial
Measured: 12 Months
Caries Arrest of Teeth in the SDF Group Measured by Dentin Texture (Soft, Hard)
Texture of the cavity's dentin of soft means the cavity is still an active infection. If the cavity is hard, the cavity is no longer an active infection (has been arrested).
Please note dentin texture cannot be assessed for the Conventional group as the dentin is no longer accessible following baseline treatment.
Measured: 12 Months
Restoration Integrity for Teeth in Control Group (Secondary Caries, Lost Restoration, Restoration Needing Repair)
Secondary caries, lost restorations, or restorations needing repair are treatment failures.
Treatment failures were assessed throughout the 12 month duration of the trial, and children with treatment failures were removed from the trial for further clinical treatment.
Measured: 12 Months
Signs of Pulpal Pathology (Lesion Reaching the Pulp Requiring Pulpular Treatment-pulpotomy and/or Pulpectomy-, Reversible Pulpitis, Irreversible Pulpitis, Abscess)
Signs of pulpal pathology are treatment failures. Treatment failures were assessed throughout the 12 month duration of the trial, and children with treatment failures were removed from the trial for further clinical treatment.
Measured: 12 Months

Secondary outcomes (9)

Number of Providers Who Find Treatment With SDF More Favorable in Time for Treatment (More, Same, Less)
Data collected at baseline only.
Measured: Baseline
Number of Providers Who Find Treatment With SDF More Favorable in Ease of Treatment (Easier, Harder, Same Difficulty)
Measured: Baseline
Number of Providers Who Find Treatment With SDF More Favorable in Preference of Treatment Modality (More Preferable, no Preference, Less Preferable)
Measured: Baseline
Parent Assessment of Appearance of Child's Teeth
Parents were asked "Are you concerned with the appearance of your child's teeth?"
Measured: 12 Months
Parent Assessment of Treatment Provided
Parents were asked "If your child had another cavity, would you be willing to have that tooth treated with the same treatment option provided to your child in this study?"
Measured: 12 Months
Child Assessment of Appearance of Teeth (Very Happy, Not Happy or Sad, Very Sad)
Measured: 12 Months
Child Assessment of Experience During Dental Visit (Didn't Hurt, Hurt a Little, Hurt a Lot)
Measured: 12 Months
Costs of Treatment (Dollars)
Cost of one application of SDF and one 1-2 surface conventional restoration. Cost was calculated by taking the average Medicaid reimbursement across all U.S. states.
Measured: Baseline
Time of Treatment Procedures (Duration of Time in Minutes)
Measured: Baseline

Timeline

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

Jan 201618 Sep 2020

First posted10 Nov 2015 (estimated)
Study startJan 2016
Primary completion18 Sep 2020
Study completion18 Sep 2020

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for CariesStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 98 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02601833
Sponsor's protocol ID: HUM00097829
Status last verified: Oct 2021
First submitted: 2 Nov 2015
Last updated: 22 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Cleary J, Al-Hadidi R, Scully A, Yahn W, Zaid Z, Boynton JR, Eckert GJ, Yanca E, Fontana M. A 12-Month Randomized Clinical Trial of 38% SDF vs. Restorative Treatment. JDR Clin Trans Res. 2022 Apr;7(2):135-144. doi: 10.1177/23800844211072741. Epub 2022 Feb 4.
PubMed 35120408

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?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effectiveness of Silver Diamine Fluoride as a Treatment for Caries in Comparison to Traditional Restorative Techniques: A 12 Month Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02601833
Acronym / sponsor ID: HUM00097829
Conditions: Caries
Keywords: Caries, Cavity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 98 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: Mott Children's Health Center
Study start: Jan 2016
Primary completion: 18 Sep 2020 (actual)
Study completion: 18 Sep 2020 (actual)
First posted: 10 Nov 2015 (estimated)
Results: Posted 22 Nov 2021

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Silver Diamine Fluoride	Experimental	Device: Silver Diamine FluorideThis arm will receive Silver Diamine Fluoride applied to their carious lesion, in lieu of restoration placement, with the goal of arresting caries.
Conventional Caries Management	Active comparator	Procedure: Conventional Caries ManagementRestorative dental care according to American Academy of Pediatric Dentistry guidelines. This treatment typically includes administration of local anesthesia, placement of rubber dam, caries removal with rotary and hand instruments, and placement of a final restoration.

Who may qualify

Ages: 2 to 10 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Presence of at least one active (soft) cavitated carious lesions in the primary dentition, extending into dentin (ICDAS 5 or 6)
The selected tooth must have a one or two surface lesion (more than 1/3 of the crown of the tooth must be remaining) and must allow for direct application of SDF
Study teeth will not have any spontaneous or elicited pain due to caries, tooth mobility, or signs of pulpal infection
Selected primary teeth must have an anticipated exfoliation date greater than 12 months away

Key exclusion criteria (5 listed)

Hereditary developmental defects such as Amelogenesis Imperfecta and Dentinogenesis Imperfecta
Severe medical conditions that do not allow the child to be managed in the clinic
Known allergy /sensitivity to dental materials being used, including SDF
Inability of the child to cooperate for treatment, recall examinations, or periapical radiographs
Wards of the State, for consenting reasons

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 FluorideAlso: Silver Dental ArrestNo caries removal will take place. The tooth will be dried and Silver Diamine Fluoride will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet.	Device	Silver Diamine Fluoride
Conventional Caries ManagementAlso: Filling, RestorationThese children will receive restorative dental care in alignment with the American Academy of Pediatric Dentistry guidelines, within the confines of the Mott Children's Health Center clinic. This treatment typically includes administration of local anesthesia, placement of rubber dam, caries removal with rotary and hand instruments, and placement of a final restoration.	Procedure or surgery	Conventional Caries Management

Primary outcome

Caries Arrest of Teeth in the SDF Group Measured by Change in Size
Time frame: 12 Months
Number of participants in the SDF arm that had an increase in lesion size at any point in the 12 months of the trial, as this is a treatment failure. Treatment failures were assessed throughout the 12 month duration of the trial, and children with treatment failures were then removed from the trial for further clinical treatment.
Caries Arrest of Teeth in the SDF Group Measured by Dentin Color (Yellow, Brown, Black)
Time frame: 12 Months
Color of the cavity at the end of the trial
Caries Arrest of Teeth in the SDF Group Measured by Dentin Texture (Soft, Hard)
Time frame: 12 Months
Texture of the cavity's dentin of soft means the cavity is still an active infection. If the cavity is hard, the cavity is no longer an active infection (has been arrested). Please note dentin texture cannot be assessed for the Conventional group as the dentin is no longer accessible following baseline treatment.
Restoration Integrity for Teeth in Control Group (Secondary Caries, Lost Restoration, Restoration Needing Repair)
Time frame: 12 Months
Secondary caries, lost restorations, or restorations needing repair are treatment failures. Treatment failures were assessed throughout the 12 month duration of the trial, and children with treatment failures were removed from the trial for further clinical treatment.
Signs of Pulpal Pathology (Lesion Reaching the Pulp Requiring Pulpular Treatment-pulpotomy and/or Pulpectomy-, Reversible Pulpitis, Irreversible Pulpitis, Abscess)
Time frame: 12 Months
Signs of pulpal pathology are treatment failures. Treatment failures were assessed throughout the 12 month duration of the trial, and children with treatment failures were removed from the trial for further clinical treatment.

9 secondary outcomes

Number of Providers Who Find Treatment With SDF More Favorable in Time for Treatment (More, Same, Less)
Time frame: Baseline
Number of Providers Who Find Treatment With SDF More Favorable in Ease of Treatment (Easier, Harder, Same Difficulty)
Time frame: Baseline
Number of Providers Who Find Treatment With SDF More Favorable in Preference of Treatment Modality (More Preferable, no Preference, Less Preferable)
Time frame: Baseline
Parent Assessment of Appearance of Child's Teeth
Time frame: 12 Months
Parent Assessment of Treatment Provided
Time frame: 12 Months
Child Assessment of Appearance of Teeth (Very Happy, Not Happy or Sad, Very Sad)
Time frame: 12 Months
Child Assessment of Experience During Dental Visit (Didn't Hurt, Hurt a Little, Hurt a Lot)
Time frame: 12 Months
Costs of Treatment (Dollars)
Time frame: Baseline
Time of Treatment Procedures (Duration of Time in Minutes)
Time frame: Baseline

Results and safety

Results posted to the registry on 22 Nov 2021, 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	56	40
Conventional Caries Management	42	29

Primary outcome: Caries Arrest of Teeth in the SDF Group Measured by Change in Size

Time frame: 12 Months. Count of participants. Unit: Participants

Measure	Silver Diamine Fluoride n = 56
Value	10

Primary outcome: Caries Arrest of Teeth in the SDF Group Measured by Dentin Color (Yellow, Brown, Black)

Time frame: 12 Months. Count of participants. Unit: Participants

Measure	Silver Diamine Fluoride n = 39
Black	37
Brown	0
Yellow	2

Population analysed: Only 39 of the 40 children who attended the 12 month visit in the SDF arm had cavities available for assessment. One child's tooth exfoliated (fell out) normally one week prior to the 12 month appointment. Please note dentin color cannot be assessed for the Conventional group as the dentin is no longer accessible following baseline treatment.

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

Time frame: 12 Months. Count of participants. Unit: Participants

Measure	Silver Diamine Fluoride n = 39
Soft Dentin	10
Hard Dentin	29

Population analysed: Only 39 of the 40 children who attended the 12 month visit in the SDF arm had cavities available for assessment. One child's tooth exfoliated (fell out) normally one week prior to the 12 month appointment. Dentin texture cannot be assessed for the Conventional group as the dentin is no longer accessible following baseline treatment.

Primary outcome: Restoration Integrity for Teeth in Control Group (Secondary Caries, Lost Restoration, Restoration Needing Repair)

Time frame: 12 Months. Count of participants. Unit: Participants

Measure	Conventional Caries Management n = 42
Missing restoration	1
Secondary caries and lesion progression	1
Intact restoration	40

Population analysed: Please note restoration integrity cannot be assessed for the SDF group as this group does not receive a restoration.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Silver Diamine Fluoride	0 of 56 (0%)	36 of 56 (64.3%)	0 of 56
Conventional Caries Management	0 of 42 (0%)	3 of 42 (7.1%)	0 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35120408Cleary J, Al-Hadidi R, Scully A, Yahn W, Zaid Z, Boynton JR, Eckert GJ, Yanca E, Fontana M. A 12-Month Randomized Clinical Trial of 38% SDF vs. Restorative Treatment. JDR Clin Trans Res. 2022 Apr;7(2):135-144. doi: 10.1177/23800844211072741. Epub 2022 Feb 4.

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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.

Margherita R Fontana, DDS, PhD principal investigator

University of Michigan

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Silver Diamine Fluoride and Conventional Caries Management in people with Caries, run by University of Michigan at 2 sites 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 4 inclusion and 5 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 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 22 Nov 2021). 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?

Caries Arrest of Teeth in the SDF Group Measured by Change in Size (time frame: 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 NCT02601833, which also lists 1 linked publication.

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 22 Nov 2021.