The Silver Bulletin
Volume 16
Posted on August 17, 2026Phase 3 Clinical Trial – Complete and Published
After years of planning and work, the phase 3 clinical trial developed to support the Advantage Arrest® Silver Diamine Fluoride 38% Breakthrough Therapy Designation from the FDA for the arrest of carious lesions has been published. Dr. Margherita Fontana et. al., completed the study spanning years including the covid shutdown, with enough patients and enough data that the NIH-appointed Data Safety and Monitoring Board study closed the study to new children early because adding more participants would not have changed the far-reaching positive outcomes.
In their article published in the prestigious journal JAMA Pediatrics, the researchers concluded “In this randomized clinical trial, 38% SDF was significantly more effective than placebo for arresting dentin caries lesions in primary teeth in young children with S-ECC, providing a noninvasive treatment for young high-risk children and supporting its consideration for FDA drug approval.” You can read the full study here.
SDF Stain removal from skin.
If you’re like most avid users of SDF, it’s only a matter of time until you get some on your skin. Removing the stain is possible, but once and while we discover an easier way to do things, and we wanted to share this one. Just be careful with povidone iodine, as it can stain clothing. Here's a video of it being used.
Pediatricians and the use of SDF in their offices
The American Academy of Pediatricians conducted a survey on the knowledge and use of Silver Diamine Fluordie in pediatricans' offices. The results show that there has been very little adoption among pediatricians, although the interest in using it is high. The main delays for gaining use in these practices is lack of adequate training and a defined reimbursement method. You can find the full survey result here.
The use of Potassium Iodide reduces effectiveness of SDF
A published study reviewed the use of SDF and potassium iodide both in the effects of reducing staining, and also the amount of silver and fluoride the treated sites release. It found that sites treated with both SDF and KI release less silver and fluoride, and the stain increases over time to near normal SDF staining levels. The abstract is available here.
SDF GEL retrospective study on prevention of caries
A previous study demonstrated the efficacy of SDF GEL followed by fluoride varnish in the arrest of carious lesions. Now, a retrospective study looking at the same children who received treatment vs children in their same class that did not get treated showed that SDF GEL and Varnish has a lasting effect on formation of new caries. The study showed kids treated at 3-4 yrs of age with SDF GEL and Varnish at age 6-7 yrs had a prevalence of new caries rate of 4.4% vs. untreated kids having a 66.6% prevalence of new caries. Read the full study here.
Invasive Documentary
If you’ve been looking for a way to communicate minimally invasive dentistry (MID) practice to your colleagues and patients, a documentary will soon be released that will cover this topic. The team at ChartHouse Films has spent the past year interviewing some of the leading minds in MID and preventive dentistry. They’ve compiled a documentary designed to educate the public that we can treat tooth decay with medicine, and not just a drill. For now, only the trailer is available but look for the full documentary to be released soon. You can see the trailer here.
ADA video on SDF
The American Dental Association has released a video summarizing their position, guidance and application instructions for SDF. You can view the video here.
Prevention of Caries by SDF vs Fluoride Varnish
Recently published research looked at how well SDF prevents caries lesions from developing as compared to 5% sodium fluoride varnish. This is different than the well-known ability of SDF to arrest lesions. In this double-blind randomized superiority trial, researchers looked at 730 children with nearly 18,000 sound tooths surfaces. They found that the semiannual application of SDF is superior to fluoride varnish at preventing caries in primary upper anterior teeth for proximal and smooth tooth surfaces. You can view the article here.
American Samoa SDF training.
Dr. Peter Milgrom and Dr. Ohnmar Tut traveled to American Samoa, a territory of the United States to provide SDF training to all the dental personnel on the Islands working in public health and community health centers. They also provided Grand Rounds on Oral Health and SDF for the medical staff of LBJ Hospital. The didactic course work, labs, and supervised clinic practice focused on well-baby care and maternal oral health.
This is part of an overall effort to introduce SDF in American territories and American-affiliated Pacific Island States where untreated dental caries is a serious problem. The training was sponsored by HRSA, MCH, Pacific Islands Primary Care Association, and the AASTDD.
Images below
The Silver Bulletin®
Vol 1, October 25, 2017
Breakthrough Therapy Designation for the Arrest of Early Childhood Caries
On October 30, 2016 Advantage Silver Dental Arrest, LLC and Elevate Oral Care, LLC announced that the U.S. Food andDrug Administration (FDA) has granted “Breakthrough Therapy Designation” to Advantage Arrest™ Silver Diamine Fluoride 38% for the arrest of tooth decay in children and adults.
Breakthrough Therapy Designation represents the FDA’s effort to address an unmet, serious, life-threatening medical need where there is no available therapy. It is a process designed to expedite the development and review of drugs that are intended to treat a serious condition as soon as possible and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies on a clinically significant endpoint(s).
AAPD Guidelines for SDF Use!
The first professional organization recommendations for Silver Diamine Fluoride use were just issued. They come from the American Academy of Pediatric Dentists and recommend Silver Diamine Fluoride be considered as a treatment option. Some notable comments include, "Surgical-restorative work in young children and those with special management considerations (e.g., individuals with special health care needs) often requires advanced pharmacologic behavior guidance modalities (e.g., sedation, general anesthesia). These pathways of care have additional health risks and limitations (e.g., possible effects on brain development in young children, mortality risks), and often are not accessible, at all or in a timely manner. The U.S. Food and Drug Administration has issued a warning, [that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than three may affect the development of children’s brains.]” Also, "With caries lesion arrest rates upwards of 70 percent (i.e., higher than other comparable interventions), SDF presents as an advantageous modality. Besides its efficacy, SDF is favored by its less invasive (clinically and in terms of behavior guidance requirements) nature and its inexpensiveness. And finally, "The undesirable effects of SDF (mainly esthetic concerns due to dark discoloration of carious SDF-treated dentin) are outweighed by its desirable properties in most cases, while no toxicity or adverse events associated with its use have been reported." Read the full AAPD Guidelines here, and see their patient chair-side guide here!
Grants
The work to fully understand Silver Diamine Fluoride continues. We can’t say it better than the two press releases from New York Uuniversity and The University of Michigan. Take a read!
Congratulations to NYU for receiving this PCORI grant!
The University of Michigan study below will be the pivotal Phase III trial for the Caries Arrest Claim for Advantage Arrest.
Light-Cure – it doesn’t “cure” in the way dental materials do, but it does react.
The application of SDF is a learning curve as we discover new attributes to the chemistry and new uses in conjunction with restorative work. We know that SDF is light sensitive liquid, and that exposure to light causes silver to oxidize rapidly. Originally clinicians thought light-curing SDF after application and a 60 second soak period on the tooth would simply show where the SDF is placed. Now we’re learning that doing this may limit the free silver ions available in the tooth, and cause them to oxidize which renders them useless or less effective. With this information, we don’t recommend light-curing SDF treated surfaces. The only time we’d consider this is if it’s used under a restoration where aesthetics are a concern. Light-curing after a minimum 60 second soak will allow you to see the discoloration and clean up any margins that may not be aesthetically pleasing. Otherwise, don’t light-cure it.
The randomized controled trials demonstrating the efficacy of SDF for caries arrest do not use a curing light as part of their protocol. There is lack of formal research on the impact of light on the efficacy SDF, therefore, we recommend against it.
Varnish over SDF
If you’re applying a liquid that you want to interact with the tooth, wouldn’t you want it to remain there on the surface and active for as long as possible? We do. This is why we recommend you apply SDF, allow it to soak for about 60 seconds, and then paint over that surface with fluoride varnish. This process uses the resin of the varnish to create a barrier holding saliva out and SDF in. Don’t worry, there’s not too much fluoride as we’ll explain below. If you can’t get a 60 second soak on the tooth (i.e., pediatric patient), applying a fluoride varnish over the top can help prevent SDF from being washed away by saliva.
SDF and Fluoride Exposure
One drop of SDF is approximately 25 μL and should be sufficient to treat 1-5 teeth. This drop contains about 11.88 mg of SDF. The Lethal Dose (LD) of oral administration of SDF is approximately 520 mg/kg body weight; while LD subcutaneous administration is 380 mg/kg body weight so there is a large margin of safety. Additionally, a child of 10 kg would receive 1.185 mg/kg of fluoride which is 1/10th the amount of fluoride in a fluoride varnish application. If you use our FluoriMax 2.5% NaF Varnish, there's even less total fluoride.
If we use the 380mg/kg number, that is a 400 fold safety margin. The EPA has also set short term silver exposure levels in drinking water at 1.142 mg per L for 1-10 days. Applications of SDF greater than one week apart fall in line with these recommendations. The EPA long term exposure limits have been set at 1 gram to safely avoid argyria.
According to Vasquez et. al. in the study below, the highest applied dose of 2.37 mg would enable 400+ applications over a lifetime. http://www.biomedcentral.com/content/pdf/1472-6831-12-60.pdf
In short, it's best to be overly cautious. One Drop of SDF contains roughly the same amount of fluoride as a properly fluoridated liter of water. If you're using a sodium fluoride varnish after SDF application, use a 2.5% NaF Varnish rather than a 5% NaF Varnish.
New Approved Uses for Advantage Arrest in Canada!
Our partners in Canada have been working with Health Canada to gain new claims (approved uses) for Advantage Arrest. In late September they received notification that Advantage Arrest will not only have the caries prevention claim in Canada but it will also have these new claims.
- Arrests the progress of an already formed cavity in primary teeth.
- Arrests the continuation of a cavity that has already formed in primary teeth.
- Helps arrest the progress of an already formed cavity in permanent teeth.
- Helps arrests the continuation of a cavity that has already formed in permanent teeth.
- Helps to temporarily reduce (painful) tooth sensitivity due to air exposure in adults.
Staff Meetings & Webinars with CE
Here’s the impact you can receive from one of our staff meetings.
Hello Craig:
Thanks again for lunch and the great information you provided. Several of my staff came up to me that afternoon and said that was the best Lunch 'n Learn they have ever attended. I agree. There was a lot of good information and products to check out. I'll be going over all the info you provided in the next week or so and go from there. One side note - both of the patients that were in the lobby commented on all the good information they were hearing from you AND the male patient asked for a fluoride treatment before he left because of the things you were saying about fluoride!! I owe you one.
Colleen Israelson DDS
This is just one of many compliments our team gets from great Staff Meetings and Lunch & Learns across the country. We can provide AGD continuing education hours, information on the latest products (even if they aren’t Elevate Oral Care’s) and the latest preventive techniques and practices such as CaMBRA. If we don’t have a Preventive Care Consultant in your area, we’ll conduct a webinar and send samples before hand so you can experience them as they are discussed.
Cleaning SDF Stains
If you catch SDF on a surface before it dries, use an ammonia based cleaner such as Windex, or Lysol wipes.
So far for dried and set SDF stains, Mr. Clean Magic Eraser, and bleach have been the go to options, while Bar Keepers Friend and Comet are good options as well. For skin, water and salt slurry as well as hydrogen peroxide have been effective to some extent.
But stay tuned; we’re working on something to help remove the stain even better! We’ve developed a chemistry that removes stains from counters and most other surfaces. As soon as it is ready for market you'll be the first to know.
Other Silver Bulletins can be seen here: