Prevora offers the highest (Type 1) level of evidence on its safety and efficacy - documentation which is unmatched amongst caries prevention products. Two randomized controlled clinical trials have been completed, two clinical trials are underway. Two human studies of the pharmacology of Prevora have also been completed, as well as a rat toxicology study, two pre-clinical pharmacology studies, and stability studies.
Two randomized controlled clinical trials have been completed with the Prevora coating. These studies are unique in the caries research literature in that:
- they involved relatively large study populations;
- they enrolled patients considered to be at risk of caries;
- they involved patients ranging in age from 11 to 80 years;
- they used different controls, including the standard of care;
- they evaluated the entire caries process from non-cavitated lesions to cavitated lesions, and;
- they evaluated efficacy in terms of arresting the progression and/or promoting the reversal of the caries lesion.
The first controlled study evaluated Prevora's ability to reduce dental caries in older patients (mean age of 58 years) who were at high risk because of medication-induced xerostomia. Over one year's treatment and observation, compared to a coating without chlorhexidine (placebo), the Prevora patients in Clinical Study #001 experienced 24.5% (p = 0.03) fewer lesions on all tooth surfaces, and 40.8% (p = 0.02) fewer lesions on root surfaces.
The second controlled study of Prevora tested its efficacy in preventing caries in young adolescents at risk of this disease because of a history of tooth decay and elevated levels of S. mutans. The comparative treatments were a placebo coating, the standard of preventive care (fluoride varnish and dental sealants), and care by the family dentist. Over three years, a significant preventive effect was found in the female participants of the Prevora group who experienced 20% (p < 0.05) fewer lesions than placebo group, 28% (p < 0.05) fewer than those cared for by the family dentist, and 31% (p < 0.05) fewer than the standard of care.
There was no comparable treatment effect for the boys in Clinical Study #002. Behavioural and nutrition studies of adolescents in the community where this study was conducted reported significant gender differences in sugar intake, the consumption of acidic sugared drinks, and in oral hygiene (See Guide for the Dental Professional). Chlorhexidine's effect in the oral cavity can be challenged by both sugar intake33 34 35 and pH36.
In short, Prevora's treatment effect can be challenged by poor diet and oral hygiene; however, the same is true for other preventive treatment regimens.
A summary of the research studies behind Prevora is available in The Guide for the Dental Professional.
Approved by Health Canada - Drug Identification Number 02046245
