Table 1 Comparison of common fluoride products
Silver diamine fluoride 44,800 ppm
5% fluoride varnish 22,600 ppm
APF (in office) 12,300 ppm
NaF2 (Rx) 9,000 ppm
Rinse (Rx) 3,300 ppm
SnF2 w/ACP 970 ppm
CPP ACP with fluoride 900 ppm
OTC .05% NaF2 rinse 200 ppm
Safety and toxicity
The safety profile of SDF is remarkable. The maximum dose
was determined to be one drop ( 25 uL) of SDF per 10kg (~ 22
lbs.) per treatment visit, based on LD50 rat studies required
for FDA clearance using a 400-fold safety margin. 3 LD
stands for “Lethal Dose.” LD50 is the amount of a material,
given all at once, which causes the death of 50% (one half) of
a group of test animals. The LD50 is one way to measure the
acute toxicity of a material. 12
Topical application of SDF to teeth with caries lesions is
very safe. One drop of SDF is roughly equivalent to drinking
a liter of fluoridated water or using fluoridated toothpaste.
Also, a good proportion of the material on the brush remains
on the brush and is never bioavailable, further reducing the
dose and potential for toxicity.
Classification, coding, and cost
In 2014, SDF was cleared by the US Food and Drug Admin-
istration for marketing as a Class II medical device to treat
tooth sensitivity. Like fluoride varnish, SDF is used off label
to treat caries lesions.
SDF became commercially available in the US in 2015
and is marketed as Advantage Arrest by Elevate Oral Care
LLC (West Palm Beach, Fla.). In January of 2016, the Current Dental Terminology (CDT) billing code 1354 became
active. It is interesting to note that this process took only
one year as compared to fluoride varnish that took 16 years.
CDT 1354 can be used for “Conservative treatment of an
active, asymptomatic caries lesion by topical application of a
caries-arresting or inhibiting medicament without mechanical removal of sound tooth structure.” With the introduction
of CDT 1354, some third-party payers have started to reimburse for the application of SDF, but reimbursement has yet
to become widespread. SDF is cost effective at $. 60 per drop
(one drop treats approximately five surfaces). In fact, some
state Medicaid programs are currently reimbursing for CDT
In October 2016, SDF attracted further attention by be-
ing awarded breakthrough therapy designation by the FDA
because it demonstrated “substantial improvement over
Table2: CDT codes used for fluoride
Note: In March 2017, the ADA Code Revision Committee approved the change from “per application”
to “per tooth” beginning January 1, 2018.
Who can place SDF?
A licensed dentist in any state can apply SDF. We advise all
other clinicians to examine their states’ dental board practice
acts to determine if they can place SDF. For hygienists, this
web site may be helpful: http://www.adha.org. Many state
regulatory agencies consider SDF under existing guidance for
the use of topical fluorides.
1. SDF is used for the treatment of high or extreme caries risk
patients, especially those with xerostomia or severe early
childhood caries (SECC). 6-9, 11 (see Figure 1)
Figure 1: Pre-and post-operative SDF on a xerostomic patient
(Photos courtesy of Dr. Angela Lee)
Arresting a lesion before conservative caries removal and
final restoration, if needed, will preserve tooth structure
and reduce mechanical pulp exposures. It is also
indicated for patients with multiple caries lesions that
may not all be treated in one visit, or will likely get worse
before treatment can be completed (e.g., long waiting
time for hospital dentistry under general anesthesia).
2. SDF is warranted when traditional treatment is chal-
lenged by behavioral or medical management.
3. SDF may access areas impossible to reach with
traditional approaches, including partially erupted
third molars, furcations, and under and around existing
restorations. (see Figure 2)
Figure 2: SDF Application in difficult to reach locations.
(Photo courtesy Monica
Savalli RDH, DDS)