Fluoride varnish continues to gain strength for its 'unlabeled' purposes
BY Cathy Hester Seckman, RDH
It's been around since the 1970s in Europe and Canada, and since the 1990s in the United States. But though fluoride varnish is widely known and used off-label as a caries preventive, the USFDA still, as of July 2014, labels it for use only as a cavity liner and desensitizer. The FDA's Dental Devices Branch outlines the approval process that would be necessary for relabeling:
"The FDA would always review any future applications requesting a new use for a device. This would necessitate an actual submission from a company with supporting data for a new use of fluoride. FDA would be happy to review any data that supports the use of fluoride varnishes for caries prevention in an actual submission. It also depends on how much fluoride is in the product and what specific claims are being made."2
Varnish was first developed to lengthen the contact time between tooth surfaces and fluoride. Beyond that, varnish mixes with saliva to deposit calcium fluoride on tooth surfaces. The deposits form a reservoir of fluoride ions, which are released when plaque pH drops. Varnish is especially effective in demineralized lesions, since a large amount of fluoride can be layered there.3
Varnish is typically supplied in 5% concentrations of either sodium fluoride or difluorsilane, which is higher than gels or foams. Varnish may also include other ingredients. Cervitec, for instance, contains chlorhexidine. Zooby Varnish, introduced just this year by Denticator, contains xylitol, as does Kolorz ClearShield, VarnishAmerica, and Preventech's Vella. 3M ESPE Vanish includes tricalcium phosphate, while Clinpro White contains functionalized tricalcium phosphate. Enamel Pro by Premier contains amorphous calcium phosphate. A component of Bifluorid is calcium fluoride. MI Varnish by GC America offers CPP-ACP, recently shown to reduce the depth of carious lesions around orthodontic brackets.4
We tend to associate professional fluoride varnish treatments with children because of their ease of use, but many other dental populations can benefit, and varnish could be a logical choice for them. Special-needs patients of any age who have short attention spans, experience difficulty in sitting still, are medically compromised, or are combative are good candidates for quick and easy varnish procedures.
Senior patients with xerostomia and increased caries may find traditional fluoride treatment too onerous. Those who deal with Parkinson's disease, back trouble, permanent tracheotomies, Alzheimer's disease, dementia, or swallowing disorders will all find varnish procedures easier to handle.
Patients of any age, according to the American Dental Association, may benefit from fluoride varnish as a caries preventive. Their evidence-based clinical recommendations state that patients younger than 6, ages 6 to 18, and over 18 years of age who fall into the moderate or high caries risk categories may be advised to have fluoride varnish treatments every three to six months.7
When asking fellow hygienists why they don't use varnish regularly, they don't cite research papers they've seen or articles they've read. They say, "Because our dentist thinks it's too expensive." I've never been responsible for ordering, so I've always taken other people's word for that. It took some time to find out for myself, but yes, fluoride varnish can be much more expensive than fluoride gel or foam. Many of the varnish products, however, are regularly offered as sale specials and in package deals with other products, which temporarily brings the price down.
Step 1: finding a unit dose - Looking online at dental supply company catalogs and querying several companies, I was able to identify unit doses for different sizes of varnish, gel, and foam. Varnish was easiest, since it's already packaged that way. This is, of course, one of the reasons why varnish is more expensive than gel or foam.
According to Young Innovations, a Perfect Choice 17.5-ounce bottle of gel provides up to 68 full-mouth fluoride treatments. That would equal a unit dose of .26 ounces. For simplicity, I'll assume that other manufacturers' products have about the same unit doses. Since some other brands of fluoride gels are packaged in 16-ounce bottles, let's further assume that at .26 ounces, those would contain up to 61 full-mouth treatments. A 12-ounce bottle of gel would contain about 46 treatments.
A 4.4-ounce aerosol can of Zooby fluoride foam provides up to 55 full-mouth treatments, again according to YI, making that unit dose .08 ounces. Fluoride foam packaged in 5.8-ounce bottles would provide up to 72 full-mouth treatments; 7.4-ounce bottles would hold about 92 treatments. A disadvantage with foam is that it's very easy to dispense too much foam per tray, thereby wasting the extra foam. It's also worth noting that the American Academy of Pediatric Dentistry states there is only limited evidence that foam is as effective as gel and varnish.8
Step 2: finding a unit price - Keep in mind that prices for fluoride products change frequently and vary with distributors. Sales, specials, and package deals are frequent, so these prices, collected over several days in mid-June, will just give you an idea of general price differences between fluoride types.
So, for fluoride varnish, I checked more than a dozen products in three different online catalogs. To make comparison simple, I only checked regular prices for quantities of 50, 100, or 200. The lowest price found for varnish was $1.33 per dose (purchasing 200 doses), and the highest was $2.24 per dose (purchasing 100 doses).
The rock-bottom price for fluoride gel was 27 cents per unit dose, and the highest was 64 cents per dose. I've sometimes worked for dentists who insisted on ordering the cheapest product, but there were always tradeoffs. The bottle cap would fail, or the product would be too chalky, too sticky, or too runny to use, or the kids would hate the taste more than usual. If you have to throw a bottle away before it's empty, how much money did you save?
Looking at fluoride foam, I found a rock-bottom price of 27 cents per unit dose, but the rest were all above 39 cents. The most expensive was 54 cents per unit dose.
To make a fair comparison between varnish, gel, and foam, I also looked at the regular cost of trays in packages of 50 to 200. Most offices probably use them for every gel or foam procedure. For trays, the best unit price found for four different brands on three websites was 15 cents per double tray; the highest was 80 cents per double tray. Single-arch trays ranged from 6 cents for two trays to 20 cents for two trays. Possibly the double trays cost more because of the extra engineering and material involved. Remember that the very cheap trays might not be a bargain if they don't fit right or hold the product reliably.
Are we finished? Not quite. Think about time and labor costs for a minute. Researchers at the University of Toronto compared the costs and patient acceptability of fluoride foam and varnish, when professionally applied. Needless to say,
patient acceptability was much greater with varnish. The study also discovered that the varnish procedure uses considerably less time than the foam procedure (which is nearly identical to the gel procedure). With children ages 3 to 6, the time difference was more than three minutes (5.22 vs. 8.61). If you typically see eight patients a day, and assuming all of them needed a fluoride treatment, that would save nearly a half hour that you could use more efficiently.9
I did not investigate fluoride office rinses because they don't seem to be very popular, and because most of the research on rinses focuses on the home-use formulas, not the in-office formulas. I did find two brands of office rinses for sale, at 60 cents per unit dose and 47 cents per unit dose.
This is the bottom line. If you use the least expensive fluoride varnish for a patient, it will cost $1.33. If you use the cheapest fluoride gel or foam with the cheapest trays, it will cost 33 cents. The cheapest in-office rinse will cost 47 cents per dose. Don't forget that with varnish there are significant savings in time and labor costs. Don't forget, either, that taking advantage of sales and special offers would bring the cost of varnish more in line with gel.
As convenient as it might be, some dental offices don't like using fluoride varnish because of concerns that it might clog suction lines or cuspidor drains. I've never had this happen, but I'm very conservative with varnish, and don't always use the entire unit dose. The problem may be more common when the entire dose is used all the time. Potential clogs can be avoided by giving the patient a paper cup or towel to spit out any excess. They can also spit into the bib before it's thrown away.
Nancy Brohawn, a hygiene friend from Delaware, offered these tips for any sticky varnish residue that might get on the patient's face and lips. "I use Lubricoat by DUX that is a dream for removing this. For sticky hands, I use a squirt of hand sanitizer with alcohol that takes it right off."
Anyone interested in debating fluoride choices with an employer might ask this question: Which is more important: the increased efficacy of varnish, plus the greater acceptance and comfort of patients, plus the savings in time and labor for the hygienist; or finding the cheapest gel/foam/rinse price and getting the cheapest product? RDH
1. American Dental Association Council on Scientific Affairs. Professionally applied topical fluoride: Evidence-based clinical recommendations. JADA. 2006;(3)1151-1159.
2. Email communication with Jennifer Haliski, press officer, USFDA, 7-15-14 through 7-17-14
3. Aulio-Gold G. Recommendations for fluoride varnish use in caries management. Dentistry Today. Dec. 31, 2007. Accessed 7-14-14.
4. Pithon MM, Dos Santos MJ, Andrade CS, Leão Filho JC, Braz AK, de Araujo RE, Tanaka OM, Fidalgo TK, Dos Santos AM, Maia LC. Effectiveness of varnish with CPP-ACP in prevention of caries lesions around orthodontic brackets: an OCT evaluation. Eur J Orthod. Jul. 4, 2014. pii: cju031. [Epub ahead of print]
5. Beltrán-Aguilar ED1, Goldstein JW, Lockwood SA Fluoride varnishes. A review of their clinical use, cariostatic mechanism, efficacy, and safety. J Am Dent Assoc. May 2000;131(5):589-596.
6. Jeevarathan J, Deepti A, Muthu MS, Rathna Prabhu V, Chamundeeswari GS. Effect of fluoride varnish on Streptococcus mutans counts in plaque of caries-free children using Dentocult SM strip mutans test: a randomized controlled triple blind study. J Indian Soc Pedod Prev Dent. Oct.-Dec. 2007;25(4):157-163.
7. American Dental Association Council on Scientific Affairs. Professionally Applied Topical Fluoride: Evidence-based Clinical Recommendations JADA 2006;137(8):1151-1159.
8. AAPD Guideline on Fluoride Therapy. www.aapd.org. Accessed 7-11-14.
9. Hawkins R, Noble J, Locker D, Wiebe D, Murray H, Wiebe P, Frosina C, Clarke M. A comparison of the costs and patient acceptability of professionally applied topical fluoride foam and varnish. J Public Health Dent. Spring 2004;64(2):106-110.
There are many advantages to using varnish rather than another type of fluoride; the most obvious is the temporary adhesive that keeps varnish in place for several hours, allowing a slow and sustained fluoride release. Another major advantage is the fact that because the varnish adheres so quickly to teeth, almost none is ingested. It's this quality that makes varnish so safe for infants and toddlers. According to the CDC, "no published evidence indicates that professionally applied fluoride varnish is a risk factor for dental fluorosis, even among children younger than 6 years of age."5
Adherence also makes varnish the best choice for gaggers and those with sensitive stomachs. Even the most violent gagger has an easier time with varnish.
Varnish can be applied in seconds, a valuable asset when dealing with infants, challenging children, or anyone who finds it difficult to sit still with a tray in their mouth for four minutes. Some varnish manufacturers recommend just a single, fast swipe across the labials, with the product spreading on its own. Time savings can also be an advantage for a busy office.
A 2014 randomized, controlled, triple-blind study showed that fluoride varnish significantly reduced counts of S. mutans in caries-free children.6