American Dental Association

Off-Label and Totally Legal: What the FDA Won’t Say About Fluoride Varnish & SDF

May 29, 2025 By Trish Walraven Leave a Comment

Fluoride Varnish and Silver Diamine Fluoride (SDF)

Let’s play a little game. Imagine your fluoride varnish brush could talk. You pick it up, ready to slather it across the facial and lingual surfaces of your patient’s teeth, and it whispers:

Psst… I’m only here for sensitivity.”

Excuse me? We both know that’s not the real reason you’re using it. You’re using it to prevent cavities. So why the double life?

Not-So-Secret Agents: Fluoride Varnish & SDF

If you work in dentistry, you know there are two magical fluids we love using to fight decay without breaking out the drill: fluoride varnish and silver diamine fluoride (SDF).

But here’s the kicker: neither is FDA-approved for the thing we all use them for – you know, the actual preventing or arresting of cavities. They’ve got their little badges that say, “I’m here to reduce sensitivity,” and that’s it. It’s like hiring a security guard to scare off pigeons and they stop a bank robbery instead. Not exactly their “official” job, but they’re killing it nonetheless.

So… Are We Doing Dentistry Wrong?

Not at all. This is what the grown-up version of medicine looks like: off-label use. That means we, as clinicians, are allowed to use products in ways that aren’t specifically written on the packaging, as long as there’s good science behind it and we’re not just winging it with snake oil and hope.

Fluoride varnish has been used off-label for decades to prevent caries. Every major dental organization (ADA, AAPD, CDC) backs it. It’s reimbursed by Medicaid for that purpose in many states. Even pediatricians – outside of a dental setting – are authorized to apply fluoride to children’s teeth under certain medical guidelines. But the label? Still just for hypersensitivity.

Silver diamine fluoride (SDF) – same deal. It got FDA clearance in 2014 for sensitivity. But its real superpower is stopping decay in its tracks. You paint it on a mushy lesion and – bam! – it freezes like Elsa just sang at it. Black, hard, ugly-but-healthy decay. Not glamorous, but incredibly effective, especially for kiddos, elders, and patients who can’t tolerate traditional treatment.

Why Not Just Change the Label?

Here’s the not-so-fun part: getting a new FDA indication is expensive. Like, “we could build a small dental school for this money” expensive. Most of the companies that make fluoride varnish and SDF are not Big Pharma. They’re more like Little-To-Medium-Sized Dental Supply. If their product is already being widely used and endorsed for the off-label thing? Why spend millions for a gold sticker that says “Approved”?

Also, if it ain’t broke (and no one’s getting sued), they’re not fixing it.

The Ethics and the Eyebrow Raises

Now, I’m not saying you shouldn’t know what’s on-label and what’s not. It matters. Patients deserve transparency, and we owe it to them to explain why their kid’s teeth are turning black (SDF, looking at you) or why we’re applying fluoride varnish after a cleaning even though they don’t have “sensitive teeth.”

The next time you brush on that fluoride varnish or dab a bit of SDF, give a little nod to its secret identity. Off-label? Definitely. Totally legal? You bet. Cavity-fighting? That’s the plot twist they didn’t print on the package.

TL;DR for Your Patients (and Curious Colleagues)

Fluoride varnish: FDA says it’s for sensitivity. We use it for cavities.
SDF: FDA says it’s for sensitivity. We use it to stop decay cold.
Both are off-label for caries, but not off-limits.
Science is on our side.
No one’s getting arrested. (Except maybe the cavities.)

What’s your take? Are we stretching the label, or just catching up to the science? Will this be one more talking point for those on the anti-fluoride side? Share your thoughts in the comments.

References

FDA 510(k) Summary for Advantage Arrest (SDF): FDA Clearance Database
ADA Clinical Practice Guidelines for SDF: ADA.org
ADA Topical Fluoride Guidelines: ADA.org
CDC’s Take on Fluoride Varnish: CDC.gov
AAPD Policy on Fluoride Therapy: AAPD.org

How does Ebola change dental infection control?

October 12, 2014 By Trish Walraven 14 Comments

At first I wasn’t worried. I was probably like you, thinking this was halfway around the world, and that it was their problem.

And then… it wasn’t just their problem. It became mine, too.

Now, I’m no infectious disease expert. I’m simply a dental hygienist who lives in the Dallas area, the center of the recent Ebola panic. And we should be terrified of what Ebola does to its victims. It’s scary, it’s creepy, and it’s lethal, in a super-speedy, no-time-to-say-goodbye-to-your-loved-ones zombie apocalypse way that you have probably freaked yourself out about enough already.

Instead, let’s look at how this affects us in dentistry. The question that is coming up most often between dental healthcare providers right now is “what are we supposed to do?”

The CDC offered the following Q&A reply to an American Dental Association inquiry this past September:

“Can I provide dental services to someone who has recently been in West Africa?

“CDC works with partners at ports of entry into the United States to help prevent infectious diseases, like Ebola, from being introduced and spread in the United States.

“A person infected with Ebola is not contagious until symptoms appear. Signs and symptoms of Ebola include fever (greater than 38.6°C or 101.5°F) and severe headache, muscle pain, vomiting, diarrhea, stomach pain or unexplained bleeding or bruising.

“The virus is spread through direct contact [CDC emphasis] (through broken skin or mucous membranes) with blood and body fluids (urine, feces, saliva, vomit and semen) of a person who is sick with Ebola, or with objects (like needles) that have been contaminated with the virus. Ebola is not spread through the air or by water or, in general, by food.

“Dental providers should continue to follow standard infection control procedures.”

And from the ADA website:

There is no risk of transmission of Ebola from asymptomatic infected patients. According to the ADA Division of Science and Professional Affairs, dental professionals are advised to take a medical history, including a travel history from any person with symptoms in which a viral infection is suspected. If Ebola is suspected, dental professionals may need to protect themselves with physical barriers (gowns, masks, face protection, and gloves), and contact their state or local health department.

According to the CDC, “Providers should consider Ebola in patients who develop a fever greater than 101.5 degrees Fahrenheit, severe headache, muscle pain, diarrhea, vomiting, stomach pain, or unexplained bruising or bleeding 21 days after traveling from Guinea, Liberia, Nigeria, or Sierra Leone.” Standard precautions should be used on all patients as a matter of routine.

So, did you actually READ any of the statements above? Basically, it’s saying to all dentists, hygienists, and dental assistants, move along, nothing here to see, business as usual as long as no one has been to Africa. Okay, so that used to be true.

The problem is that even though proper protocols are in place, that mean one of two things is happening to cause Ebola to infect people in the US:

1) We are not following Universal Precautions properly, or

2) Universal Precautions as we know them are inadequate.

Case in point. Today a health care worker was accused of breaching the PPE protocol because she has been now diagnosed with Ebola. The second one in our country. It could have been the other guy; you know, the deputy who went into the Ebola apartment without a Hazmat suit that ended up getting quarantined at an urgent care center up in Frisco?

Yeah, it got pretty crazy in our town last week, because he lives here. In fact, his daughter goes to school with our son. Thankfully our town responded very amazingly to him and his family at the time of crisis and we were all very relieved that it ended up being a false alarm.

So, if the problem is that we’re not following Universal Precautions, maybe then, we all need a little more muscle memory in our procedures so that we’re already doing our best if this stuff ever does become epidemic.

I know that I’m not always faithful about taking my loupes, mask, and gloves off the perfect way, every time, but you better believe that I’m going to be practicing this with chocolate syrup on my gloves the next time I’m in the office.

Seriously, maybe it’s time for your team to refresh themselves on how to properly remove their personal protective equipment.

Come on, who wouldn’t want to be in a room full of women (as is the case with most dental teams), passing around a bottle of Hershey’s, adding a little drizzle onto each person’s gloved hands, watching the syrup slick between their latex or nitriled-up fingers, then having them do a striptease routine in front of each other to see if they contaminate themselves?

Believe it or not, this is something that the OSHA recommends. If you’d prefer the CDC’s boring version to practice, though, you can print this PDF out instead:

As far as the other scenario? The one where the infectiousness of Ebola is far, far worse than what our sacred Universal Precautions can handle? What DO you say about that? Hey, nice knowing you, I’m changing professions now, love ya, see ya around but not here, bye?

Let’s hope then – for everyone’s sake – that we have all just been sucking at taking our gloves and masks off.

A blogger since 1997, Trish Walraven, RDH, BSDH is a practicing dental hygienist and marketing manager for an indie dental software development company. She’s now concerned about the effectiveness of the mask she’s currently using in her office but continues to put it on the list of low priorities until the zombies actually come crashing into her operatory.

UPDATE – October 16, 2014:

(Now THIS is more like it!)
ADA American Dental Association
Guidance to Dental Professionals on the Ebola Virus

A person infected with Ebola is not considered contagious until symptoms appear. Due to the virulent nature of the disease, it is highly unlikely that someone with Ebola symptoms will seek dental care when they are severely ill. However, according to the Centers for Disease Control and Prevention and the ADA Division of Science, dental professionals are advised to take a medical history, including a travel history from their patients with symptoms in which a viral infection is suspected.

Any person within 21 days of returning from the West African countries Liberia, Sierra Leone and Guinea may be at risk of having contacted persons infected with Ebola and may not exhibit symptoms. If this is the case, dental professionals are advised to delay routine dental care of the patient until 21 days have elapsed from their trip. Palliative care for serious oral health conditions, dental infections and pain can be provided if necessary after consulting with the patient’s physician and conforming to standard precautions and physical barriers.

You are advised not to treat dental patients if they have the signs and symptoms for Ebola. If a patient is feeling feverish and their travel history indicates they may be at risk of Ebola, dental professionals and staff in contact with the patient should:

• protect themselves by using standard precautions with physical barriers (gowns, masks, face protection, and gloves)
• immediately call 911 on behalf of the patient
• notify the appropriate state or local health department authorities
• ask the health department to provide you and your staff with the most up-to-date guidance on removing and disposing of potentially contaminated materials and equipment, including the physical barriers.

The Ebola virus is spread through direct contact (through broken skin or mucous membranes) with blood and body fluids (urine, feces, saliva, vomit and semen) of a person who is sick with Ebola, or with objects (like needles) that have been contaminated with the virus. Ebola is not spread through the air or by water or, in general, by food. Again, there is no reported risk of transmission of Ebola from asymptomatic infected patients.

Prosthetic joint wha-what?

December 19, 2012 By Trish Walraven Leave a Comment

Bendy fake joints may not be susceptible to the bacteria introduced during dental procedures after all.

According to a systematic review of the research involving prosthetic knees and hips conducted collaboratively by the American Dental Association and the American Academy of Orthopaedic Surgeons, it was announced yesterday that there was no increase in the odds of developing a prosthetic joint infection as a result of invasive dental procedures.

This means that the Antibiotic Prophylaxis Guidelines have been updated with some sort of vague blurburbmush gabble guhg that essentially states what I’ve been saying for YEARS! When patients ask why they have to choke down those four huge amoxicillin capsules an hour before their dental visit, my answer has been something along the lines of “because it protects the dentist against liability.” This has taken some tact, of course, with explanations of how open sores in the mouth allow bacteremias every time that a toothbrush pops open a pocket and causes untold blood-squirtage- these aren’t necessarily negotiated with daily doses of doxycycline. We’ve all realized it’s good homecare, not an antibiotic, that is the key to preventing oral bacteria from getting into the bloodstream and infecting artificial joints.

Thank you, ADA, for affirming the overkill of antibiotic prophylaxis.

For the rest of the story, here’s the link:

http://www.ada.org/news/8061.aspx

_________

Update 1/2/2015:

Antibiotic premedication for joints is still not recommended.This clarification was published by the ADA yesterday:

Background. A panel of experts (the 2014 Panel) convened by the American Dental Association Council on Scientific Affairs developed an evidence-based clinical practice guideline (CPG) on the use of prophylactic antibiotics in patients with prosthetic joints who are undergoing dental procedures. This CPG is intended to clarify the “Prevention of Orthopaedic Implant Infection in Patients Undergoing Dental Procedures: Evidence-based Guideline and Evidence Report,” which was developed and published by the American Academy of Orthopaedic Surgeons and the American Dental Association (the 2012 Panel).

Types of Studies Reviewed. The 2014 Panel based the current CPG on literature search results and direct evidence contained in the comprehensive systematic review published by the 2012 Panel, as well as the results from an updated literature search. The 2014 Panel identified 4 case-control studies.

Results. The 2014 Panel judged that the current best evidence failed to demonstrate an association between dental procedures and prosthetic joint infection (PJI). The 2014 Panel also presented information about antibiotic resistance, adverse drug reactions, and costs associated with prescribing antibiotics for PJI prophylaxis.

Practical Implications. The 2014 Panel made the following clinical recommendation: In general, for patients with prosthetic joint implants, prophylactic antibiotics are not recommended prior to dental procedures to prevent prosthetic joint infection. The practitioner and patient should consider possible clinical circumstances that may suggest the presence of a significant medical risk in providing dental care without antibiotic prophylaxis, as well as the known risks of frequent or widespread antibiotic use. As part of the evidence-based approach to care, this clinical recommendation should be integrated with the practitioner’s professional judgment and the patient’s needs and preferences.

CONCLUSIONS

Evidence fails to demonstrate an association between dental procedures and PJI or any effectiveness for antibiotic prophylaxis. Given this information in conjunction with the potential harm from antibiotic use, using antibiotics before dental procedures is not recommended to prevent PJI. Additional case-control studies are needed to increase the level of certainty in the evidence to a level higher than moderate.

The entire content can be read here:

http://jada.ada.org/content/146/1/11.full

Paper behaving badly

January 3, 2012 By Trish Walraven Leave a Comment

I never trust faxes.

Except for the occasional antiquated piece of paper that requires a signature that can be penned and sent right back, most of the spam that dribbles out of our office fax machine is a waste of a phone number. And sometimes we’ll even get a fax from someone who is apparently trying to steal our money.

Like this one:

Did you get this fax today, too? Seems like a lot of dentists throughout the country were targeted by some idiot that has never watched TV. Like, duh, don’t you know that there are all sorts of safeguards in this country against scam artists? That sooner or later when you pick up any checks that were mailed to your post office box and then when you deposit one, don’t you think that someone will be watching you?

Okay, so unless the American Dental Association has outsourced its money handling to another part of the country (and they’re not asking for your state and local dues anymore!), it’s pretty safe just to ignore this fax. Or, if you’re feeling creative, you can use it to test the rat-smelling of your business manager, but I wouldn’t recommend the possibility of throwing away over $500 just to reinforce something you probably already know.

Thanks to Dr. Craig Harder for sending me this copy so that I can chuckle at the stupidity of its sender, and possibly warn a few of the less-savvy users of heavy office equipment that the faxes they receive may not always behave themselves.

You have been naughty, fax machine. Time to shut you down.

Jan 19, 2012 UPDATE:

The ADA sent out this eMEMO today:

On January 3, all ADA member dentists with an email address in our database received a special communication from the ADA to alert them about fraudulent invoices that were faxed to many dental offices. As follow-up, we are providing members with an update on what has occurred since our initial communications.

Background

On January 3, a number of member dentists contacted the ADA regarding the fraudulent invoices, prompting the Association to distribute an alert that afternoon to member and nonmember dentists, leadership and staff at state and local dental societies, recognized specialty organizations and other organizations and individuals within the dental community. A standby statement was also prepared for the media.

The alert stated that the ADA does not use fax communications to collect membership dues, and that the ADA does not sell, rent or publish in any way the fax numbers of current or former member dentists in our database. Additionally, all dues invoices for tripartite members are mailed from state or local dental societies, and invoices for other ADA “direct” membership categories are sent by mail as well.

The fraudulent fax appeared to be a standard invoice that asked the recipient to send a $575 payment to the American Dental Association/ADA Association, Membership Processing Dept., P.O. Box 1403, Brockton, MA 02303-1483.

Dentists whose offices were in receipt of a fax as described above were advised to not respond or send payment to the P.O. box.

In a statement from ADA Executive Director Dr. Kathleen O’Loughlin, “Getting the word out and taking steps to protect our members have been our top priorities,” adding that there was no breach of ADA information or member data.

Update on actions by the ADA
The ADA has continued to work closely with U.S. Postal Service authorities. The following is a brief summary of what has occurred to protect our members:

On Jan. 5, within 48 hours of hearing about this issue, the ADA filed a civil action in the Boston federal court that issued a temporary restraining order (TRO) requiring that any mail sent to the P.O. box to be held by the U.S. Postal Service and not made available to the individual renting the P.O. box.

On January 17, the TRO issued previously was converted into a preliminary injunction, and the file has been unsealed.

The U.S. Postal Inspection Service is considering instituting an investigation, and has also referred the matter to the U.S. Attorney’s office in Boston for possible criminal prosecution.

What to do if you received one of the faxed invoices
Do not send a payment. Additionally, if you still have a copy of what you believe may be a fraudulent invoice, please forward it to Tom Elliott, deputy chief legal counsel, by email at “[email protected]” or by fax to 312.440.2562, along with your name and ADA number.

What to do if you sent a payment to the P.O. box
So far the Post Office in Brockton has received more than 170 pieces of mail to the P.O. box. It is hoped that the action the ADA took to seal the post office box occurred before any checks were received, as the box was empty when it was sealed on January 5.

•As a precaution, if your office has sent a check to the P.O. box, we encourage you to “stop payment” on the check. While there is normally a small cost associated with this, there is also the comfort of knowing your check cannot be cashed.
•We also ask that you contact the ADA Member Service Center at 800.621.8099. ADA staff is assembling a list of dentists known to have sent checks so we can communicate with and reconcile records with the U.S. Post Office. You will be asked to complete a release form that will allow us to verify if the P.O. box has received a check from you. Additionally, we are told the U.S. Postal Service plans to communicate directly with those individuals who have sent mail to the P.O. box.

Dentists are urged to share this information with all staff on their dental team and direct further questions or concerns to the ADA Member Service Center at 800.621.8099.

ADA Session No-Nos

October 14, 2011 By Trish Walraven 2 Comments

For the most part, the American Dental Association meeting in Las Vegas this past week was a dignified, educational, and exciting exhibition. On the other hand, this article is dedicated to some of the stuff that didn’t go over so well.

Exhibit No. 1: Booth Babes

Really? If this is what it takes to sell your dental products, you probably need better products. Hot girls are nice and all, but you seem to have forgotten that half of dentists these days are women themselves.

Exhibit No. 2: Excessive use of color

I get it already. But yellow is the least of the problems here.

Exhibit No. 3: Roll it, don’t fold it

When you only have one thing hanging up at your booth, you really should make sure that thing isn’t creased and messy-looking.

Exhibit No. 4: Voyeurism

An interproximally wedged bit of corned beef begged me to visit the Sonicare AirFloss demo after lunch, and of course I’d been wanting to try it out ever since its preview here at DentalBuzz. What I didn’t realize was that a bunch of people would be peeking their heads around the corner from the sinks while I shot microbursts between my teeth.

Exhibit No. 5: You look stupid

There’s two ways to get into this group. If you’re getting paid to look like a fool, hey, in this economy, at least you have a job! And then there’s the second way, which proves that paper crowns should only be passed out to small children at Burger King.

Exhibit No. 6: Pretentious company names

But the URL was available!!!! Even the kids wearing the orange shirts look skeptical.

Exhibit No. 7: Unpretentious company names

And sometimes you should try harder to come up with a name for your business.

Exhibit No. 8: Pawn Stars

Editing is a reality TV show’s best friend, as evidenced by the Pawn Stars Roadshow held at the ADA meeting.There were the obligatory purchases of dental gold (3.5 ounces for $2,000, on one sale) but for the most part the items that were brought on the stage for appraisal were met with yawns, disinterest, and concerns about authenticity.

One thing’s true though: the reality show’s stars are the real deal. What you see on the History Channel’s number one show is what you get. Not only did pawn shop owner Rick Harrison share his story about how he became the “media whore” that he is today (his words, not mine) and his experiences in the dental chair, we got a glimpse of the real Chumlee Russell when he accidentally fell off the back of the stage. Now I know why there are “I Heart Chumlee” shirts for sale all over Vegas.

Exhibit No. 9: Bad planning

So, you create a display area for a show that’s esthetically pleasing and then JACK IT UP with loud hand-scribbled posters. Either they forgot to offer a show deal or it’s genius marketing to make it look like they’re going out of business and have the BEST SHOW SPECIAL EVER! And what’s with the unapproachable chick stance? Wow, tough sell.

Exhibit No. 10

There’s no exhibit number ten. I just wanted to make fun of this guy again: