Dental CariesPhase 3NCT02536040
Stopping Cavities Study: Diammine Silver Fluoride
A Phase 3 study testing 38% diammine silver fluoride and Water in people with Dental Caries, run by Advantage Dental Services, LLC at 1 site in United States.
Trial summary
This study is being conducted to test whether the use of diammine silver fluoride (also called silver diamine fluoride) hardens the cavity sufficiently so that it arrests. Read more about this study
- Who is it for?
- Ages 24 to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- 38% diammine silver fluoride and Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jul 2016
- 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 24 to 60 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Nyvad criteria 3
- Active carious lesion
Who cannot join
- Allergy to silver
- Stomatitis or oral ulcerative condition
- Weight less than 15 kg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pragmatic Trial of Topical Diammine Silver Fluoride for Dental Caries Arrest
This study is being conducted to test whether the use of diammine silver fluoride (also called silver diamine fluoride) hardens the cavity sufficiently so that it arrests.
Read the detailed description
Phase III RCT with two arms: (1) 38% diammine silver fluoride; (2) distilled fluoride free water. Subjects are 200 preschool children in good general health with untreated tooth decay. Intervention is topical application of the study drug to the open cavity. Primary outcome is caries activity at 14-21 days.
- Conditions
- Dental Caries
- Being tested
- 38% diammine silver fluoride, Water
- Keywords
- silver diamine fluoride, diammine silver fluoride, children
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
38% diammine silver fluorideDrug
Also called silver fluoride, silver diamine fluoride
treatment of cavity with study agent
WaterOther
Fluoride free, distilled water
| Study group | Role | What they receive |
|---|---|---|
| 38% diamine silver fluoride | Experimental | Topical application of 38% diammine silver fluoride to active cavity Receives: Drug: 38% diammine silver fluoride |
| Water | Placebo comparator | Topical application of fluoride free water to active cavity Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental Caries Activity
Proportion of treated teeth with active decay that were arrested by the treatment measured using the Nyvad criterion code 6 reflecting hardness of the lesion and color change
Measured: 14-21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2015 (estimated)
- Study startJan 2016
- Primary completionJul 2016
- Study completionJul 2016
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 Dental 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advantage Dental Services, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Milgrom, DDS, Study director, Advantage Dental Plans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536040
- Sponsor's protocol ID
- 003
- Status last verified
- Aug 2016
- First submitted
- 27 Aug 2015
- Last updated
- 23 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Trial of Topical Diammine Silver Fluoride for Dental Caries Arrest
- ClinicalTrials.gov ID
- NCT02536040
- Acronym / sponsor ID
- 003
- Conditions
- Dental Caries
- Keywords
- silver diamine fluoride, diammine silver fluoride, children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Advantage Dental Services, LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 31 Aug 2015 (estimated)
- Results
- Posted 23 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to test whether the use of diammine silver fluoride (also called silver diamine fluoride) hardens the cavity sufficiently so that it arrests.
Detailed description
Phase III RCT with two arms: (1) 38% diammine silver fluoride; (2) distilled fluoride free water. Subjects are 200 preschool children in good general health with untreated tooth decay. Intervention is topical application of the study drug to the open cavity. Primary outcome is caries activity at 14-21 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 38% diamine silver fluoride | Experimental | Drug: 38% diammine silver fluorideTopical application of 38% diammine silver fluoride to active cavity |
| Water | Placebo comparator | Other: WaterTopical application of fluoride free water to active cavity |
Who may qualify
- Ages
- 24 to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Nyvad criteria 3
- Active carious lesion
Key exclusion criteria (3 listed)
- Allergy to silver
- Stomatitis or oral ulcerative condition
- Weight less than 15 kg
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 |
|---|---|---|
| 38% diammine silver fluorideAlso: silver fluoride, silver diamine fluoridetreatment of cavity with study agent | Drug | 38% diamine silver fluoride |
| WaterFluoride free, distilled water | Other | Water |
Primary outcome
Dental Caries Activity
Time frame: 14-21 days
Proportion of treated teeth with active decay that were arrested by the treatment measured using the Nyvad criterion code 6 reflecting hardness of the lesion and color change
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Dental Caries
Not yet recruitingObservational study
Artificial Intelligence Versus Clinical Examination in White Spot Lesions Detection, Identification, And Scoring
White Spot Lesion of Tooth
Recruiting
Oral Health Intervention in Adult Primary Care
Dental Caries, Dry Mouth
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
Not yet recruiting
This Feasibility Study Will Evaluate the Study Protocols for Treatment and Follow-up Controls of Primary Molars With Caries in Children Treated With Stainless Steel Crowns or Conventional Fillings. Treatment Success and Potential Failures Will be Followed at 3, 6 and 12 Months Post Treatment.
Dental Caries, Early Childhood Caries (ECC)
Recruiting
A Study to Evaluate the Cariostatic Efficacy of Nano Silver Fluoride (NSF) vs. Silver Diamine Fluoride (SDF) in Children
Dental Caries
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.
Peter Milgrom, DDS study director
Advantage Dental Plans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 38% diammine silver fluoride and Water in people with Dental Caries, run by Advantage Dental Services, LLC 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 3 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 23 Jan 2020. 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. Some participants in this study may receive a placebo. 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 23 Jan 2020). 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?
Dental Caries Activity (time frame: 14-21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2020.