In the latest article in our ongoing series from Dental Protection, JULIA DENSEM considers the issues that dentists need to be aware of if they intend to offer tooth whitening to their patients.

The dark winter nights have been brightened by the new law on tooth whitening, which came into force on October 31, 2012. European dentists can now legally provide tooth whitening for their adult patients, using products containing or releasing up to 6% hydrogen peroxide, subject to various conditions outlined below. The change in the law arises from a change in the EU Directive concerning cosmetic products.

The Dental Council has published guidance entitled ‘Tooth Whitening – Guidance to the Dental Profession’ to reflect the change in the law.

The new regulations allow the use of hydrogen peroxide and other compounds or mixtures that release hydrogen peroxide, including carbamide peroxide and zinc peroxide, to be used for tooth whitening. The maximum concentration that may be used for tooth whitening under the regulations is 6% present or released. In very broad terms and as a general guide, a percentage expressed in terms of carbamide peroxide content will release one-third of that level of hydrogen peroxide. Thus, the commonly used products containing 16% carbamide peroxide would be permitted under the revised regulations because they would normally release less than 6% hydrogen peroxide.

The regulations with reference to Ireland set out that products containing or releasing up to 6% hydrogen peroxide can be used, subject to conditions:

• to only be sold to dental practitioners;
• for each cycle of use, first use by a dental practitioner;
• afterwards to be provided to the consumer to complete the cycle of use; and,
• not to be used on a person under 18 years of age.

To only be sold to dental practitioners
Under the regulations, only dental practitioners can purchase tooth-whitening products containing or releasing up to 6% hydrogen peroxide. Dentists should not provide tooth-whitening products containing or releasing more than 0.1% hydrogen peroxide to patients who are not under their care.

For each cycle of use, first use by a dental practitioner
The first use of each cycle must be by a dentist. The regulations do not set out how long the trays must remain in the mouth for the first use. This will be a clinical judgement for the dentist. Dental Protection advises members to make a detailed contemporaneous record of the instructions given to the patient at the first appointment, which becomes central to demonstrating their compliance with the law.

The requirement that the first use of each cycle is by the dentist means that tooth-whitening products containing or releasing more than 0.1% hydrogen peroxide cannot be sold to patients at reception or by post.

Hygienists
The conditions under which hygienists are permitted to work are laid down by the Dentists Act 1985 and a scope of practice providing more detail as to the tasks that hygienists are entitled to carry out was published by the Dental Council in September 2005. Tooth whitening is not listed in the code of practice as a task that hygienists are permitted to undertake.

In its recent guidance on tooth whitening, the Dental Council has clarified that in Ireland tooth whitening can only be carried out by a registered dentist and as the regulatory framework currently stands, dental hygienists or orthodontic therapists arenot permitted to perform tooth whitening.

Afterwards to be provided to the consumer to complete the cycle of use
After the first in-surgery application, the patient can be provided with the tooth-whitening product for home use. If the patient requires additional product for that course of treatment, the product should be dispensed by the dentist, who is trained and competent to provide tooth whitening.

Medical Devices Directive
Some manufacturers in Europe are marketing tooth-whitening products containing or releasing more than 6% hydrogen peroxide as medical devices. Even if a tooth-whitening product is marketed as a medical device it falls within the regulations and the EU Directive. This means that it is not possible to circumvent the regulations by using a product that has a CE mark.

Under 18s
The regulations and EU Directive specifically state that the product should not be used on patients under 18 years of age. This means that it is only possible to use products containing or releasing up to 0.1% hydrogen peroxide on patients who are under 18.

This may create a legal and ethical dilemma for dentists who consider, for example, that it would be in the best interests of a particular patient less than 18 years of age, to provide tooth whitening to an isolated non-vital tooth. The dentist may consider that other treatments, for example crowns or veneers, would be unnecessarily destructive to the tooth/teeth. In this scenario it is an individual clinical decision for the member whether to breach the regulations to provide the treatment that the member considers to be in the best interests of the child.

Dental Protection advises:
• If a dentist wishes to provide treatment to a child in breach of the regulations, they are advised to have a detailed discussion with the patient/parents, as part of the consent process. Ensure that the patient/parents are fully informed as to the risks and benefits of both bleaching procedures, and the more interventive alternatives, including a discussion about the legal status of tooth-whitening procedures and whether it is appropriate to delay treatment until the patient is 18 years of age.
• Document all consultations carefully in the patient’s clinical notes – this is essential in order to demonstrate that appropriate discussions have taken place with the patient, and their parent(s) where applicable – before the procedure is carried out.
• Dentists are advised to refer to the current Dental Council guidance regarding tooth whitening, as well as the joint Dental Council/Irish Medicines Board statement, which provides helpful advice on the treatment of patients under the age of 18.

In providing treatment in breach of the regulations, dentists should recognise that they could leave themselves vulnerable to a complaint being made to the Irish Medicines Board and/or Environmental Health Officers of the Health Service Executive (HSE) (see ‘Breach of the Regulations’). Dentists should ensure that they discuss the case with their indemnity provider.

Over 6%
The use of products containing or releasing more than 6% hydrogen peroxide is a breach of the regulations. Dental Protection advises its members to comply with the law, where compliance is in the best interests of the patient.

The clinician needs to weigh the risks of using a product against the benefits of that product, when considering if a particular treatment is in the patient’s best interests. If a dentist considers that on balance it is still in a patient’s best interests to use a product containing or releasing more than 6% hydrogen peroxide, they may be challenged on the use of the product by Officers of the Irish Medicines Board and/or Environmental Health Officers of the HSE.

Dental Protection advises its members who are considering using products that release or contain more than 6% hydrogen peroxide, and thus breaching the Regulations, to:

• Take individual therapeutic decisions in respect of each patient.
• Avoid advertising the use of tooth-whitening products containing or releasing more than 6% hydrogen peroxide as this may constitute intent to supply the goods. It is also likely to attract unfavourable attention from the Irish Medicines Board and/or the HSE.
• Take advice if you have concerns or are approached by an Officer of the Irish Medicines Board or an Environmental Health Officer of the HSE.
• Ensure that patients are fully informed as to the risks and benefits of using a product containing or releasing more than 6% hydrogen peroxide as opposed to using a product using a lower concentration of hydrogen peroxide, including a discussion about the legal status of the tooth-whitening procedures. Such discussions should present a fair and balanced summary of the relative risks and benefits of alternative treatment approaches, and should not make any claims for the efficacy of one technique over another that cannot be substantiated.
• Document all consultations carefully in the patient’s clinical notes – this is essential in order to demonstrate that appropriate discussions have taken place, with the patient before the procedure is carried out, although it is worth remembering that the patient’s consent does not alter the legality of the situation.

Breach of the regulations
Dentists who breach the regulations may be subject to fitness to practice proceedings under the Dentists Act 1985, in addition to any action taken by the Irish Medicines Board or Environmental Health Officers of the HSE.

The maximum penalty for breaching the regulations is a sentence of imprisonment not exceeding six months or a fine not exceeding €3,000, or both.

If a dentist feels that he or she is at risk of being prosecuted for a breach of the regulations, he or she should contact their indemnity provider for advice.

Indemnity and assistance
The proposed relaxation in the regulations to permit the use of higher strength products containing or releasing hydrogen peroxide has significantly improved the unsatisfactory ethical and legal dilemmas that faced dental practitioners in recent years. There remain some unwelcome ‘tooth-whitening’ anomalies, including the eligibility of a hygienist to provide tooth whitening and situations where the patient is under 18.

Dental Protection will consider requests for assistance in relation to bleaching and tooth whitening procedures on their individual merits. Members of Dental Protection who carry out these procedures in accordance with the law can seek assistance in the usual way if facing any kind of complaint or challenge. An advantage of the flexible indemnity offered by Dental Protection is that discretion can be exercised to assist a member in difficulty. Contract-based insurance is restricted by the wording of the policy. Dentists should check with their indemnity provider on the level of assistance available in situations where it was in the patient’s best interests to act in breach of the regulations by using a stronger concentration.

Conclusion
Dental Protection welcomes the new law as it allows dentists to act in the best interests of the majority of their patients, while remaining within the law. Some dentists may be frustrated by the residual ethical problems associated with higher concentrations and patients under 18, but the new legislation is a giant step forward. The long nights will be brightened by the whitened smiles of patients.

Julia Densem LLM PgDL LDSRCS BDS
Julia is a full-time dento-legal adviser with Dental Protection and has been responsible for monitoring the developments in the formulation of the latest European Directive on cosmetic products.