The Prevention of Adult Caries Study of Prevora Achieves Full Enrolment
Tuesday, August 19th, 2008Hello,
As many of you know, Prevora, the antibacterial tooth coating used in Canadian dental offices to prevent root caries, has a very large program of randomized controlled studies and practice management studies underway. One of these studies, the Prevention of Adult Caries Study, has been underway for more than a year and has recently met an important milestone. See below.
Some interesting observations from this study are:
- an excellent safety profile, similar to what we have seen in other studies and in Canadian dental office use
- a ready supply of patients. The study is enrolling adult patients with advanced stages of this chronic disease, primarily from existing patient caseloads. Seems this disease is as prevalent as many of the epidemiological studies report, and as many of the Prevora users indicate.
I am excited about this growing base of evidence for Prevora, which we will share with our accounts over the coming months.
Thanks for your interest,
Tyler
The Prevention of Adult Caries Study of Prevora Achieves Full Enrolment.
CHX Technologies Inc., a specialty pharmaceutical company developing new preventive products for adult oral diseases, announced today that the Prevention of Adult Caries Study (PACS) of the antibacterial tooth coating called Prevora (100 mg/ml chlorhexidine acetate) has completed enrolment of study participants. Recruitment started in spring 2007, and 983 participants have been randomized in PACS.
PACS is a pivotal Phase III randomized, controlled clinical trial conducted under CHX Technologies’ Investigational New Drug license with the U.S. Food and Drug Administration. The study is expected to be the final study before filing a New Drug Application for Prevora to the FDA and is believed to be the largest study of its kind. PACS’ clinical endpoint is decayed tooth surfaces and the trial’s threshold for efficacy is a 20% reduction of such surfaces in the treated arm of the study versus placebo over one year.
Efficacy results from PACS are expected in the first half of 2010.
PACS has been sponsored largely by the National Institute of Dental and Craniofacial Research, one institute of the National Institutes of Health (NIH). The study is being conducted at four clinical centers. At baseline, the mean age of the study participants was 43, and the mean number of decayed tooth surfaces was 33. Two out of three study participants in PACS visit the dentist at least once a year.
Tooth decay has become a common adult disease as the population ages. The U.S. Center for Disease Control reported last year, for example, that about one third of American seniors under age 74 had tooth decay at the gum line (also called root caries). Root caries is caused by a low-grade asymptomatic bacterial infection. Its emergence in older Americans is largely related to gum recession and the taking of several prescription drugs each day. It is a form of tooth decay which is difficult to treat with conventional restorative procedures and which has been reported to have connections to overall health.
Prevora is a clear and temporary tooth coating applied by the dental professional to the teeth of adult patients in a short, painless appointment. Prevora delivers on a sustained release basis, a common and safe antimicrobial compound, called chlorhexidine, to the bacterial infections on the teeth. This coating has been approved by Health Canada for the reduction of tooth decay at the gum line, and by the Irish Medicines Board for the reduction of tooth decay in adults and adolescents. CHX Technologies has begun marketing Prevora to dentists in several communities in Southern Ontario, and expects to proceed through mutual recognition in late 2008 for broader European approvals in 2009.
Prevora is the first new antibacterial product indicated for the reduction of adult tooth decay available to the dental professional. It is also the first product in CHX Technologies’ development program which is uniquely focused on new proven preventive dental products for the aging population.
For more information contact:
Ross Perry
CHX Technologies Inc.
