The headline proclaims that the featured dental sealant means “Filling Cavities Without the Drill.” But the product is not actually approved to fill cavities, as the manufacturer’s web site puts it, the sealant “cannot be used in cases of advanced decay” and it “is not the same as a traditional filling.” The body of the story points out that the product is used on pits that are too small to be filled, in hopes of preventing further development, but readers are likely to be misled by the headline and lead paragraphs.
The story also calls the product new, but in its application for FDA approval the manufacturer said the sealant is “substantially equivalent” to other sealants that have been available for more than a decade.
News stories should avoid confusing minor conditions with more serious ones. In this case, the story touts an alternative to drilling and filling cavities, but the featured product (like fluoride, brushing, flossing and cutting back on sugary soda) is actually intended to reduce the risk of a cavity developing.
Oddly, while the story says this product is cheaper than drilling and filling a cavity… and it includes a comment from an expert saying this product is more expensive than other approaches to preventing cavities, it does not say how much this product costs.
The story headline promises “Filling Cavities Without the Drill.” However, the featured product is not approved for filling cavities. It is a sealant that is intended to prevent the potential development of cavities. As the manufacturer stated in its applications to the FDA:
“Product Indications for Use:
The Sealant (Infiltrant) is indicated for:
* Sealing of Pit and Fissures
*Sealing/facing of damaged enamel surfaces
* Covering of caries predilection sites during orthodontic treatment
* Sealing of secondary teeth
* Sealing of deciduous teeth”
“Sealing of damaged enamel surfaces and exposed dentin surfaces of teeth to prevent caries and Protective coating for tooth surfaces predisposed to caries or on early non-cavitated lesions (including use in tooth brush abrasion and root surfaces).”
(Quotes from FDA 510k summaries listed above.)
The story does not mention any harms from this product, so we would typically rate it as Unsatisfactory. However, a review article published last year on this sort of sealant also did not mention any side effects. The article did mention that there was a great deal of variation in how these products are used in different countries indicating that there is no clear consensus on how they should be used.
Sealants in Dentistry: Outcomes of the RCA Saturday Afternoon Symposium 2007
Caries Research 2010;44:3–13
The story reports that, “Studies say the Icon resin treatment stops decay 85 percent of the time.” However, the story does not give any information about the studies. The manufacturer’s web site displays abstracts from a number of studies performed by the product developers. These studies appear to involve only a few participants or are lab tests performed on extracted animal teeth.
The premise of this story is that the featured product is an alternative to drilling and filling a cavity. However, this product and others like it are not intended as an alternative to fillings at all, they are used to seal pits that might (or might not) grow into cavities if the patient doesn’t take better care of his or her teeth. In other words, the story misrepresents the health issue that the product is meant to address.
Although this story includes comments from an independent source and it identifies the lead researcher as being on of the product’s developers… it fails to point out that the dentist featured in the story also has received financial support from product’s manufacturer.
The story points out that fluoride treatment and other methods are less expensive, less invasive and have a longer track record than the featured product. However, the headline and lead anecdote portray the product as an alternative to traditional fillings, which is not an approved use of the product.
The story reports that this product has been available in the United States for just over a year. However, it does not say whether dentists need to be trained to use the product.
This story fails spectacularly on this criterion. The featured product is called “one of several new cavity treatments that avoid drilling.” But in its application for approval to the FDA, the manufacturer says the product is basically the same as other sealants that have been available for more than a decade:
“The Infiltration Kit materials are substantially equivalent to several currently marketed dental restorative materials including the following:
3M CliNPRo Sealant K992326 (3M Company USA)
Admira Seal K021842 (VOCO, GmbH)
Grandio Seal K062344 (VOCO, GmbH)
FDA 510k summary, March 26, 2010
FDA 510(k) Summary, Sep. 18, 2008
The story does not appear to be based on a news release.