“Off-Label” Benefits of Varnish

Beyond the Label

The “off-label” benefits of using fluoride varnish for caries prevention

Dentists and hygienists have been applying high-concentration fluoride compounds directly to patients’ teeth for over 50 years. Interestingly, there has been an uptick in the number of fluoride varnishes being introduced in the last several years. According to the FDA, varnish is indicated for use as a desensitizer and cavity liner, but many are recognizing its “off-label” use as a topical fluoride treatment. With all the fluoride products and delivery systems on the market, does fluoride varnish measure up?


The most widely used fluoride application in dental practices is 1.23% acidulated phosphate fluoride (APF) gel (Sheehan 2001). In 1993, 1.23% APF foam hit the market. It is claimed to deliver the same protection as APF gel with 75 percent less fluoride, which lessens the risk of a toxic amount being accidentally swallowed. However, some research has shown that both foam and gel deliver the same amount of fluoride.


shutterstock_71177302First introduced in the 1960s under the trade name Duraphat, sodium fluoride varnish is relatively inexpensive, easily applied to exposed root surfaces, and prolongs contact time between fluoride and enamel, thereby achieving deeper fluoride uptake (Sheehan 2001). The benefits of fluoride varnishes also include long-term fluoride release and a higher delivery of fluoride into cementum. Varnish has been used as an effective anticaries agent in Europe and Canada for over three decades (Sheehan 2001). It has not yet been approved for use in this capacity in the United States; rather, it has been cleared by the FDA for use as a desensitizing agent and cavity liner. Caries prevention is regarded as a drug claim, and companies would be required to submit appropriate clinical trial evidence for review before this product could be marketed as an anticaries agent.

That being said, fluoride varnish is still an effective caries prevention solution. According to CDC Recommendations, a prescribing practitioner can use fluoride varnish for caries prevention as an “off-label” use. The American Academy of Pediatric Dentistry emphasized in a 1996 recommendation, “Unapproved does not imply an illegal use. The word unapproved is used merely to indicate lack of approval, not to imply disapproval or contraindication based on positive evidence of a lack of safety or efficacy.”

“Although varnishes are not FDA-approved as a topical fluoride treatment […] many studies show they are clinically as effective, if not more so, than APF treatments.”
       – Dr. Timothy Wright, Professor of Pediatric Dentistry, University of North Carolina

fluoride-treatmentSeveral reviews of the use of fluoride therapies in preventing dental caries have been published since the year 2000, including 2 evidence-based reports. The Cochrane reviews of this topic concluded, “Fluoride varnishes applied professionally two to four times a year would substantially reduce tooth decay in children.” In addition, an expert panel of the American Dental Association recently concluded, “Fluoride varnish applications take less time, create less patient discomfort and achieve greater patient acceptability than fluoride gels, especially in preschool-aged children.”

Studies examining the effectiveness of varnish in controlling early childhood caries are currently being conducted in the United States. More research on fluoride varnish is likely to continue in both Europe and North America to determine optimal fluoride concentration, the most effective application protocols, and its efficacy relative to other fluoride modalities (CDC 2001).


PureLife offers the top brands of fluoride varnish, including Vanish by 3M ESPE, NUPRO White Varnish by Dentsply Professional, DuraShield CV by Sultan Healthcare, Duraflor Halo by Medicom, and the BPA-free Embrace Varnish by Pulpdent. To learn more about these great products, call our product experts at 877-777-3303.