Dental Product Evaluation

Most clinical trials evaluate the safety-in-use and efficacy of a product to help determine whether that product is appropriate for consumer use.  They may also include surveys for subjects that reveal whether they enjoy using the product and get the results they want from it. The CPT^SM team includes Board-Certified Dentists, nurses, and bio-instrumentation specialists who have developed standard protocols, or can generate custom protocols to help you reach your unique goals.  

There is an enormous variety of toothpastes on the market, for all kind of needs: toothpastes formulated to control tartar, whiten teeth, and control sensitivity, as well as products made for children, smokers, and for consumers who want natural, herbal ingredients. But all toothpastes contain some kind of mild abrasive that removes plaque from the teeth, and all toothpastes that earn the American Dental Association (ADA) Seal of   contain fluoride to prevent and reverse caries (tooth decay).

When testing toothpastes, our Board-Certified Dentists measure the amount of plaque present by applying fuchsin or another disclosing agent and grading the plaque revealed using the standard Turesky Plaque Index. They carefully monitor subjects for any sign of gingival irritation or other adverse events. For tartar-control products, they calculate the Calculus Index and track its change during treatment. When it’s necessary to investigate claims that go beyond CPT^SM’s standard protocols, our experts are able to generate one that meets client needs—and recruit the right kind of subjects needed to implement it successfully.

People who are looking for brighter, whiter teeth have many options: standalone whitening strips, gels, and varnishes are available, as well as toothpastes and mouthwashes that also offer a whitening function. These products can have many active ingredients, but most common are the bleaching products hydrogen peroxide and carbamide peroxide. Products that contain bleaching agents typically have them in such low concentrations that they are considered cosmetics, not drugs. However, stronger teeth whitening products like those supplied to dentists are more potent and must be approved by the FDA.

Even if a product doesn’t need the FDA’s approval to reach the market, it is still necessary to be sure that it is safe for human use. It is also necessary to carry out clinical trials to provide evidence for any scientific claims. For example, CPT^SM will precisely observe the color of the teeth before and after the use of the product using the VITA Easyshade^® V. This device is equipped with a 32-bit micro-controller with an ARM Cortex M3 core that allows for the determination of a subject’s tooth shade, including crowns and prosthetic teeth.  The numerical shade measurement grades provided by the instrument are based on VITA Bleachedguide 3D Master^® brightness levels, defined by the American Dental Association.

Mouthwashes come in all kinds as well, but they can broadly be broken down into cosmetic products, which do nothing but provide a pleasant fragrance and taste, and therapeutic products that go beyond that to kill germs, fight plaque, provide fluoride, or whiten teeth. CPT^SM is able to test therapeutic mouthrinse products for claims substantiation just like toothpastes or teeth whitening products that provide the same benefits. Our experts are also able to carry out analytical testing for contents. And whether a mouthwash is cosmetic or therapeutic, pleasant taste and other subjective impressions are a key part of customer satisfaction. CPT^SM can survey subjects on their experience with a product to find out what the sponsor needs to know.

CPT^SM offers additional testing options for your dental product development, in our Analytical Services and Microbiology divisions, while ensuring compliance and keeping your budgetary concerns in mind.  You can rely on our expert capabilities to assist you in bringing your product to market in the most efficient and compliant manner.