Evaluating self-care products

Nov. 1, 2002
How often have you stood at the doors of a convention hall overwhelmed by the number of aisles and booths? You want to hear about the latest self-care products for your patients, but the selection is quite confusing.

How often have you stood at the doors of a convention hall overwhelmed by the number of aisles and booths? You want to hear about the latest self-care products for your patients, but the selection is quite confusing. Almost every product has a combination of ingredients or benefits — sensitivity relief, tartar control, tooth whitening, etc.

So you categorize in your mind certain clinical signs and symptoms of your patients. You begin your product investigation based on what will serve each patient group. One group may include patients who present with exposed dentin. Often, you are aware of the documented causes — physiological wear during normal chewing, pathological wear by bruxing, cervical abrasion by incorrect or excessive brushing, abrasive agents, tooth erosion by acids, tooth abfraction by occlusal stresses, caries, and mechanical contact. You want to be able to advise these patients on selecting appropriate self-care products.

The information is compiled in order to match a certain type of product with specific symptoms. For example, an over-the-counter dentifrice or a 5,000 ppm fluoride dentifrice may be recommended to help prevent or minimize the loss of tooth structure, remineralize a sensitive area, arrest or limit caries, and/or preserve restorative dentistry. But what if, after all this inquiry and evaluation, the product recommendation may have the potential to cause more harm than good?

FDA/ADA guidelines

As a patient advocate, you try to recommend products based on sound science. Clinicians can begin their research of product recommendations by collecting information from regulatory agencies, such as the Food and Drug Administration (FDA) and the ADA Council on Scientific Affairs.

The FDA is charged with protecting the public from unsafe products. The FDA requires all OTC and prescription products to have appropriate research that demonstrates product safety. An example is the amount of fluoride allowed in a tube of toothpaste. According to the FDA, OTC toothpastes that include stannous fluoride, sodium fluoride, or sodium monofluorophosphate can be marketed as long as the fluoride level is 1,000 to 1,100 ppm.

A manufacturer can also voluntarily apply for the ADA Seal of Acceptance, which is administered by the ADA Council on Scientific Affairs. If a toothpaste manufacturer wants to apply for the ADA Seal of Acceptance, it must follow the recommended guidelines. For example, the ADA Guide to Dental Therapeutics advises the limitation of of a tube of 1.1 percent NaF dentifrice (5,000 ppp f) to about 1.85 ounces of product in a tube. This means the size and amount of a toothpaste tube is regulated by the ADA, if the manufacturer wants to be able to apply for the Seal of Acceptance. After receiving the seal, a manufacturer must reapply every three years. Products used in a dental office and those sold to the public can carry the ADA Seal.

Is it backed by evidence?

After examining information from respected regulatory agencies, hygienists need to seek out researched articles to support self-care product recommendations. Continuing with the previous discussion of exposed dentin and appropriate dentifrices, let's focus on the elusive topic of abrasivity of dentifrices.

A review of the literature on abrasiveness of dentifrices on tooth surfaces and restorative materials indicates that research is usually performed on extracted teeth in a laboratory. One often used method, the radiotracer, measures toothpaste abrasion on dentin and enamel — relative dentin abrasion (RDA) and relative enamel abrasion (REA). There is valid industry concern about the abrasiveness of products. Some early protocols suggest a dentifrice with an RDA over 200 should not be used long-term on exposed dentin. But this standard has not been widely accepted yet.

Based on a handful of clinical trials, anecdotal experience, and common sense, an accepted self-care product for areas with dentin hypersensitivity, exposed root surfaces, cervical abrasion, and microfill composite resins is a nonabrasive or low-abrasive toothpaste or a 5,000 ppm fluoride gel/dentifrice. These are thought to help prevent or minimize sensitivity and safeguard against the further erosion or mechanical removal of the dentin or restorative material. But with the lack of significant clinical evidence concerning toothpastes, how can you be sure that the OTC product labeled "sensitive" or a 5,000 ppm prescription dentifrice protects the exposed surfaces?

Because of slim clinical abstracts, we find ourselves relying on manufacturers' claims in journal advertisements and pamphlets. Many of the manufacturers make boisterous claims against their competitors. Are the claims supported by data on file? How many of you call the manufacturer and ask for a copy of this data? How many of you read it or ask the manufacturer's representative to explain it to you?

During one such quest, I discovered a "Summary of Relative Dentin Abrasion Data on Dentifrices, RDA Test on Dentifrices," conducted at the Indiana University School of Dentistry. The study looked at the relative abrasion level of seven dentifrices. The toothpastes were tested using the ADA recommended procedure for determination of dentifrice abrasiveness. The results showed that Colgate PreviDent 5000 Plus rated high in dentin abrasion. OTC toothpastes such as Crest's regular paste, as well as two of Sensodyne's brands offering features for whitening and tartar control, ranked in the second highest abrasion category. Two of Sensodyne's other brands featuring fresh mint flavor and a maximum strength version of the toothpaste's original flavor, ranked in the lowest abrasion group.

We need to ask manufacturers' representatives specific questions about products. If the product is new to the market, does it overcome the inadequacies of existing products? What is the mechanism of action? Is evidence available that supports the product's claims? A product claim's that it is new, improved, or enhanced should not alone be a determining factor for selection. Hygienists need to discover how it was improved or changed and evaluate whether or no the product merits a new or continued recommendation to your patient.

Consider the source

When asking a manufacturer about their research or product features and benefits, think about the reputation of that manufacturer. However, the hard truth is that the research being done on products is virtually all sponsored by corporations. Their fiscal involvement is a reality. That is why the reputation of the company is so important. If you are recommending prescription medications, such as 5,000 ppm fluoride dentifrices, then you had better feel comfortable that the company has done their homework on indications, FDA approvals, package size regulations, labeling, etc. Your self-care recommendations are part of your rapport and the trust factor with your patients.

Another problem with prescription dentifrices is the size of the package. Most 1.1% NaF products are packaged in a two-ounce tube of 5,000 ppm fluoride dentifrice or gel. As explained briefly before, the FDA guidelines cover OTC fluoride gels, treatments, and rinses. There is no such guide for prescription fluoride products. The OTC rules and regulations are very specific, limiting a dentifrice to no more than 276 mg of fluoride per package (1.96 ounces of a 1.1% NaF dentifrice).

In the Federal Register, the FDA attempts to address self-care professional products by stating:

"The package size limitations established for OTC fluoride dentifrices, treatment rinses, and preventive treatment gels ... are intended for products used by the general public and not for products used only under professional supervision ... The [FDA] does not believe that safety problems will occur when a larger package size is distributed for professional office use only, provided the package is not intended to be distributed by the dentist to the consumer for home use. A product marketed in this manner would present potential problems similar to an OTC product."

Manufacturers have interpreted this monograph in the Federal Register quite differently. Some market two-ounce tubes and others distribute four-ounce tubes.

The dental office's verbal instructions and the package's instructions recommend that the prescription toothpaste be safely placed in the medicine cabinet or other areas, out of a child's reach. However, certain stand-up tubes with eye-catching colors may end up sitting on the bathroom counter. Easy access, child-friendly flavors, and increased fluoride content may lead to a harmful ingestion.

By researching your self-care recommendations and partnering with helpful and reputable manufacturers, you are ensuring that you completely understand why you are picking one product over another. And, if you see me at a convention, bedazzled and confused, you can assume that I have been searching for the best products for my patients and practice.

Kristine A. Hodsdon, RDH, BS, is a coach with Hygiene Mastery, as well as an international speaker, author, and software developer. She can be contacted about speaking or coaching at (888) 347-4785 or by e-mail at [email protected] or [email protected]. Visit her on the Web at www.pre-d.com and www.hygienemastery.com.