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Peak Orthodontic Body Urges Australian Regulators To Better Inform And Protect Consumers Regarding Direct-To-Consumer Products

August 3, 2021 Dental No Comments

The peak body for orthodontists, the Australian Society of Orthodontists (ASO), is again calling for Australian health regulators to provide clear guidance to the Australian public regarding direct-to-consumer (DTC) clear aligner products.

This follows a recent statement issued by the United Kingdom statutory regulator of the dental team, the General Dental Council (GDC) on ‘direct-to-consumer’ orthodontic treatment (where clear plastic dental aligners are sent directly to a consumer’s home), accompanied by helpful information for patients and dental practitioners. While welcoming innovation in dentistry (including remote interactions and consultations in appropriate circumstances), the GDC’s statement uses simple and clear language when it comes to making clinical decisions about a proposed course of orthodontic treatment – in line with current authoritative clinical guidance, and orthodontic training, clinical judgements ‘must be based on a full assessment of the patient’s oral health’.  This is the position that the ASO has for some time been advocating with the Australian health practitioner regulator (Australian Health Practitioner Regulation Agency, or AHPRA).  Unfortunately, unlike its UK counterpart, AHPRA has not been proactive in providing clear guidance to Australian dental practitioners, their patients and the public generally when it comes to direct-to-consumer orthodontic treatment.

Since 2018, the ASO has been informing consumers about the risks associated with inadequately supervised direct to consumer clear aligner treatment, and Australian orthodontists are now seeing patients present to their clinics seeking remedial treatment following failed DTC clear aligner treatment.

 The GDC issued three documents concerning direct-to-consumer orthodontic treatment, each emphasising concern for patient care and safety, and doctor oversight.

These documents are consistent with protecting the health and safety of patients, with the key messages listed below:

  • DTC treatment is the practice of dentistry: Direct-to-consumer orthodontic treatment using clear aligners “falls within the legal definition of dentistry so can only be performed by dentists and dental care professionals who are registered with the GDC.”
  • In-person examinations are crucial for orthodontic treatment: For treatment, “a face-to-face interaction or a physical clinical assessment will be necessary to ensure patient safety.” Moreover, as noted above, clinical judgments about the suitability of a proposed course of orthodontic treatment must be based on a full assessment of the patient’s oral health. “At present, there is no effective substitute for a physical, clinical examination as the foundation for that assessment.”
  • Informed consent can only occur with direct doctor/patient interaction: Direct interaction between patient and practitioner is essential for providing patients the opportunity to ask questions, provide consent, and be satisfied that the course of treatment proposed is likely to meet their needs and expectations.”
  • Treating doctor must keep patient records: The treating dentist “must make and keep a full patient record, including the reasons for any decision to deviate from established practice and guidance.”
  • Patient must be able to directly contact their doctor: Patients must know the full name of the dental professional responsible for their treatment and be able to make direct contact with that person.”

ASO President, Dr Howard Holmes, says that the ASO fully supports the GDC’s effort to protect patient health and safety by ensuring that the public is better informed about direct-to-consumer orthodontic treatment, and calls for the regulators in Australia to review the actions taken recently by the GDC.

“Regulators across the globe are expressing concerns for patient health and safety in the context of direct to consumer orthodontic treatment, and we are pleased to see the GDC’s recent statements which are designed to protect consumers, and better inform them about this kind of treatment. In Australia, the Australian Society of Orthodontists will continue to actively advocate for patient safety and care in the direct-to-consumer setting, and we look forward to the Australian heath practitioner regulator AHPRA doing the same,” Dr Holmes said.

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