Livionex dental gel: overhyped or not?

I’ve been hearing about a new dental gel called Livionix which apparently works by preventing plaque from sticking to teeth. The active ingredient is something called edathamil, which seems to be either the same thing as, or a close chemical relative of, the common food additive EDTA. EDTA is cheap, but the dental gel is expensive ($20 per 1.7 oz tube). There have been a few studies that seem promising, but all of them are small (10-25 subjects) and published in journals whose reputations I am not familiar with:

  1. Effects of a Novel Dental Gel on Plaque and Gingivitis: A Comparative Study

  2. Comparison of Plaque Removal Capabilities between Two Dentifrices

3.Multimodality imaging of the effects of a novel dentifrice on oral biofilm

On the other hand I found reference to (but no text of) another study from 1956 in German suggesting edathamil can decalcify tooth enamal, but I have no idea what doses of edathamil were involved or how it was applied: Muhlemann, H. R., and J. C. Somogyi. Edathamil-induced decalcification of intact and fluoride-treated dental enamel [translated title]. Bulletin der Schweizerischen Akademie der Medizinischen Wissenschaften [1956, 12(6):520-527].

Questions:

  1. Edathamil is a chelator. Should we be concerned about its effect on amalgam fillings and enamel calcium?

  2. Livionix does not contain fluoride. Can it be used before or after regular fluoride toothpase and/or fluoride mouth rinse without diminishing its effectiveness?

  3. The amount of attention this product has been getting seems out of proportion to the small size of the studies that have been published. Am I overreacting?

  4. Has the manufacturer applied for ADA approval? And is the ADA ever likely to approve a fluoride-free dental gel even if it works as advertised?

I am interested as well. Just read an article on WSJ (http://www.wsj.com/articles/anti-plaque-dental-gel-excels-1470068313) about it and have been trying to find more information. The WSJ article does say they have a version with fluoride in the works. Like you have mentioned I could only find couple small studies and the rest is just junk blogs, etc. I did find this on the ADA which echoes the lack of studies.

Recently, Sir James Dyson, inventor and businessman, included a dental gel for oral hygiene on his list of 10 favorite gadgets.1 The gel is Livionex® (Livionex, Inc.), and uses what the company terms as a “proprietary technology” that activates Edathamil, a food-grade chelating compound more commonly known as EDTA. The claims made for the gel is that it interferes with harmful bacteria in the mouth and prevents biofilm from attaching to the surface of the tooth. Information from the company website includes that it reduces calcium in plaque fluid and that it does not contain abrasives, detergents, antimicrobials or fluoride.2

To date, there are two peer-reviewed studies supporting product claims of improvement in plaque and gingivitis outcomes2, 3 and one study presented online.4 None of these examined the impact of the product on erosion or caries risk, nor provided any insight about safety. Its current price of $20/1.7 ounce tube puts it outside the range of other dentifrices, which have far more data regarding safety and effectiveness. Given the small sample sizes, short study durations, and homogeneity of the populations studied, it is premature from the perspective of evidence-based dentistry to do anything more than speculate on the utility of this product in an oral care regimen.