OPINION | COSMETIC DENTISTRY | increased surface roughness and a
decrease in the adhesion between the tooth and the restorative material. In response to these concerns, as long
ago as 1993 the ADA convened a panel of experts to address the safety of bleaching materials. This led to the publication in 1994 of the ADAÕs Guidelines for the Acceptance of Peroxide-Containing Oral Hygiene Products, which have been updated periodically ever since. The Guidelines define safety and efficacy criteria for oral products containing varying forms of peroxides, and ask for safety and efficacy studies plus observation criteria that include long-term follow-up. In 2009, the ADA petitioned the Food
and Drug Administration (FDA) to establish appropriate classifications for tooth-whitening chemicals. Up until that point, the FDAÕs only involvement with such products was an attempt in 1991 to treat bleaching agents as unapproved new drugs and thus requiring FDA approval for marketing, but it backed down after a legal challenge.
Consumer Products (SCCP), part of the European CommissionÕs Directorate General for Health and Consumer Protection, published the results of a consultation on the safety of hydrogen peroxide tooth whitening systems. Following an exhaustive analysis of all
the available data, the SCCP concluded that the use of tooth whitening products containing up to 0.1% hydrogen peroxide was safe, and that the proper use of products containing up to 6% hydrogen peroxide, subject to certain caveats, should also be considered safe after consultation with and approval of a dentist. The Committee, however, recommended against the use of tooth whitening products prior to or immediately after dental restoration work, and warned that particular care should be taken in using such products by individuals with gingivitis or other forms of periodontal disease. The SCCP also drew attention to the
lack of long-term epidemiological studies of the possible adverse effects of hydrogen peroxide within the oral cavity, and said
The whole process came to fruition in
September last year, when the Council of Ministers adopted Directive 2011/84/EU, which amended the original Cosmetics Directive (Directive 76/768/EEC). The original directive had fixed the maximum concentration of hydrogen peroxide at 0.1%, although in practice products containing higher levels of hydrogen peroxide are widely used. In line with the SCCP opinion, the new Directive allows tooth whitening or bleaching products containing up to 0.1% hydrogen peroxide to continue to be freely available, and limits the sale of products containing concentrations higher than 0.1% and up to 6% to dentists. For each cycle of use of the product, the first use may only be by a dentist who has performed a clinical examination, and who then provides access to these products for the remainder of the cycle of use. In addition, persons under 18 years of
age are not permitted to use these products, even under the supervision of a dentist. Lastly, products containing more than 6% are banned. Member States have until 30 October 2012 to implement the Directive in national legislation. Despite these European moves,
Following an
exhaustive analysis of all the available data, the SCCP concluded that the use of tooth whitening products containing up to 0.1% hydrogen peroxide was safe.
In a letter to the agency in 2009, ADA
president Ron Tankersley and executive director Kathleen OÕLoughlin said that the growth in the availability of products direct to consumers and the application of products in venues such as shopping malls, cruise ships, and salons was of particular concern, as there was no guarantee of the safety of product ingredients or the doses used, or of the professional qualifications of individuals employed in such non- dental settings. The FDA has so far not taken up the ADAÕs petition.
European regulation Regulatory measures have been taken in Europe, however. The process began in 2005, when the Scientific Committee on
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that the available data did not support the safety of hydrogen peroxide up to 6% in tooth whitening products directly available to consumers. The SCCP opinion was supported by
the Council of European Dentists (CED), which unanimously adopted it at its General Meeting in November 2008. The CED, which represents more than 340000 dentists across Europe, said that there was a need for regulation of the availability of tooth whitening products at EU level; that the aim of such regulation should be to protect consumers against the potential harmful effects of excessive exposure to tooth whitening products; and that the SCCP opinion should be implemented as soon as possible.
however, the US FDA still does not approve or disapprove whitening products (although it does regulate some of the equipment used in whitening procedures). It is this lack of regulation that enables non-professional sites such as tanning parlours to offer tooth whitening.
Conclusions It is clear that, provided the individual is prepared to tolerate a small amount of discomfort, tooth whitening can be a safe and effective procedure when handled by a professional. However, for those seeking other forms of tooth whitening, there are a number of pitfalls to be avoided. As one commentator put it, if you had an exquisite piece of antique furniture that was in need of restoration, you would take to an expert renovator. You would not buy a tub of restorer at the local hardware store, nor would you hand it over to someone with a workshop, but no qualifications in antique restoration. How much more precious are your teeth than a piece of furniture?
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