Starting now, we will publish frequently a bulletin on the most recent news surrounding Silver Diamine Fluoride!
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!
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.
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; Elevate Oral Care (manufacturer) is 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.
*A courtesy of Elevate Oral Care