VOHC Studies

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Veterinary companies marketing products for companion animal dental health benefit if they can claim that their dental products reduce the formation of plaque and calculus. These veterinary dental health products can differentiate themselves from other marketed products by earning the VOHC Registered Seal. The VOHC Seal certifies the product developer followed Veterinary Oral Health Council approved standardized scientific study designs to evaluate the product’s ability to control plaque and/or calculus, and VOHC data review found the product efficacious. While the Veterinary Oral Health Council is not a regulatory agency, authorization to use the VOHC seal verifies that the results of clinical trials of the product’s  effectiveness in retarding plaque and tartar when used as directed meets VOHC’s Standards.
What is the Veterinary Oral Health Council (VOHC)?
Historically, there were no objective means or standards to assess veterinary dental products. Consumers and companies had no way to differentiate companion animal dental merchandise beyond marketing materials produced by the company. Through a series of meetings beginning at the Veterinary Dental Forum in the 1991, the concept of the Veterinary Oral Health Council was developed by interested parties, including numerous Veterinary Dental entities and the FDA.   The VOHC was officially established in 1997 as an organization within American Veterinary Dental College (AVDC) as an independent review system for the efficacy of dental plaque and calculus retardation products.
What is the VOHC Seal of Acceptance?
The VOHC Accepted Seal® is issued by VOHC to certify products tested following the VOHC approved standardized scientific study designs found the products efficacious. The scientific validity of the testing, and the independent nature of the VOHC are powerful assurance to consumers that the product works to retard plaque and/or calculus. The VOHC Accepted Seal® is a US-PTO registered mark that cannot be used in without prior approval of VOHC.

      

Who Can Benefit From the VOHC Seal?
Veterinary companies submitting companion animal dental health product successful trial data have the opportunity to receive the VOHC endorsement that their product reduces the formation of plaque and calculus. Conducting the studies needed to attain the Seal is voluntary and studies are performed at the expense of the company seeking the Seal.   This is a worthwhile investment for companies seeking to differentiate their companion animal dental health products in the market place by using the VOHC Accepted Seal®
How to Apply for the VOHC Seal
The VOHC awards the Seal in two claim categories: Helps Control Plaque, and Helps Control Tartar.   These are separate claims requiring separate sets of data, though both claims may be evaluated in the same trial.

Pre-study communication with the VOHC should start as early as possible, and all study protocols should be provided to the VOHC for review and concurrence before study initiation.   This ensures an acceptable study design is used and any product-specific considerations are addressed.  Contact our team to introduce you to the VOHC.

What is Required in a VOHC Study Program?
The scope of a VOHC study program includes these requirements and components:

  • Study conduct following good scientific practices, the Animal Welfare Act, the VOHC approved protocol, and the facility SOPs.
  • The VOHC requires two trials with the product, to insure repeatability of results. Animals used in the first trial cannot be used in a second trial.
  • Study conduct in healthy animals in the species for which the product will be used.
  • Study conducted in animals having a designated set of teeth termed “VOHC Teeth” that are intact, with normal occlusion, and are healthy.
  • The studies use the “clean mouth model” in which teeth are scaled and polished at the start of the trial, so there is no plaque or calculus present. The studies are evaluating the PREVENTION of plaque and calculus formation, not the ability to remove plaque and calculus that is already established.
  • Study conduct must employ personnel that are trained and experienced scoring teeth in dental studies. This experience must be described in the protocol.
  • The study should be randomized, controlled (placebo or negative control), and masked (personnel scoring teeth must be blinded to treatment).
  • If the product contains a chemical anti-plaque or anti-calculus agent, evidence must be provided that the agent is safe, in addition to the efficacy data.
  • Products having both chemical and mechanical action will require an additional treatment group.

You can view full study design requirements on the “Protocol and Submissions” page on the VOHC website.

Laboratory Essentials for Your VOHC Study Program
An Experience Performing Laboratory

Perhaps the single most important factor in the success of a VOHC program is the experience of the performing laboratory.   The laboratory conducting the study must have significant experience with the evaluation of dental efficacy in dogs and cats.   Sinclair has conducted dozens of studies for VOHC submission, and Sinclair data has supported many seal awards.  

Experienced Veterinary Dental Professionals

The experience of the person scoring the teeth during studies is of utmost importance.   Sinclair is proud to work with consulting veterinary dental professionals with many years of experience scoring teeth for the VOHC.

When it is time to conduct your VOHC study program, please consider Sinclair Research as the first choice in laboratory selection. We are the leading laboratory conducting studies for VOHC submissions.

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