Oral Health Group

Prevora’s latest controlled study is published


A new peer-reviewed article in Acta Scandinavia Odontologica reviews the most recent controlled study of Prevora.

This study is so far the largest randomized, multi-centre, double-blinded, placebo-controlled investigation of any preventive intervention for adult caries. It enrolled 983 adults who lived in the community and who had at least one cavity upon entering the study.

The study was conducted using a protocol co-developed with the FDA. The FDA specified the endpoint to be cavitated lesions and stipulated the analytical plan. It also required that study participants represent a good cross-section of adults in America today.

The analysis was conducted by an independent bio-statistician using a locked data base. Dr. A. Kumar, one of the authors of this article was the independent bio-statistician.

The key result from this pivotal study is shown in Figure 1, excerpted from this article. It shows that Prevora reduced cavities by 59% (p<0.005) compared to the untreated group when the study participant entered the treatment plan with 3 or more cavities.  (In fact, coronal caries were reduced by 70% in this group while there were too few root lesions to be analyzed).

This pronounced preventive effect was the reason why the European Medicines Agency and 2 other European regulatory authorities issued approval for Prevora as the only preventive treatment for caries in high risk adults.

You might ask why did Prevora work so well in high risk adults but had a reduced preventive effect in at-risk adults?  The answer is also revealed in Figure 1. At-risk adults who had 1 cavity or perhaps 2 cavities at the start of the treatment plan, also had a rate of disease occurrence (caries increment) which was less than half that of high risk adults. So, over the course of the study’s 1 year period of treatment and observation, it was difficult to show a difference between Prevora and placebo.
You might also ask which patients have 3 or more cavities going into a treatment plan? In this Prevora study, they were inner-city uninsured folks in Boston and Native Americans in Arizona. But they could also have been patients with Parkinson’s Disease, diabetic patients, patients with a dry mouth who also smoke, and patients with multiple risk factors.

From our observations, a good rule of thumb is that each hygienist sees one high risk caries patient a day.

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For more on this blog, please visit Partners In Prevention at: www.partnersinprevention.ca.

SOURCED: Partners In Prevention – http://partnersinprevention.ca/prevoras-latest-controlled-study-is-published/


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