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26 August 2014

NICE upgrades guidance after concluding ‘bionic jaw’ procedure is safe and effective

A procedure to cure a painful mouth disorder, which involves replacing part of the jaw, has been judged safe and effective by NICE. The guidance is the 500th piece of interventional procedures guidance to be published by the institute.

A procedure to cure a painful mouth disorder, which involves replacing part of the jaw, has been judged safe and effective by health experts.

The National Institute for Health and Care Excellence (NICE) has updated its guidance on a type of prosthetic replacement surgery for disorders of the joint which moves the jaw bone (temporomandibular joint)[1]. This is the 500th piece of ‘interventional procedures’ guidance[2] to be published by the institute.

It’s thought that about 1 in 6 people will have problems with 1 or both of their temporomandibular joints[3]. Symptoms include pain and difficulty opening the mouth. They can occur at any age and although most cases are not serious, a few people will need surgery.

Speaking about the condition, Professor Bruce Campbell, Chair of the Interventional Procedures Advisory Committee at NICE, explained: “Temporomandibular joint disorders affect the joint between the lower jaw and the base of the skull. They can be caused by arthritis, usually connected with getting older, but sometimes caused by  trauma or infection of the joint.  Opening the mouth becomes painful and chewing can be difficult so that people cannot eat a normal diet”.

The updated NICE guidance says that surgeons wanting to replace the temporomandibular jaw joint with an artificial implant can do so using normal arrangements for clinical governance, patient consent and audit.

It had previously recommended that special measures should be put in place before the procedure is performed[4].

Professor Campbell said the surgery should be a last resort for those in severe distress: “Total prosthetic replacement of the temporomandibular joint is only intended for people who are experiencing extreme pain or disability. It is one of a number of surgical options, which specialists will always discuss in detail with people who might need this operation”

Prosthetic replacement of the temporomandibular joint involves a general anaesthetic. The surgeon makes an incision in front of the ear and behind the lower jaw, replacing the diseased parts with artificial joints.

Professor Campbell continued: “We are pleased to be able to recommend normal arrangements for this procedure. When we originally looked at this prosthetic replacement of the temporomandibular joint in 2009 there was not enough evidence for us to advise that it worked well enough and was safe enough .

“At the time, we encouraged clinicians to collect more data to provide us with further evidence of the procedure’s long-term safety and effectiveness. We’re pleased that specialists took notice of our recommendation and recorded this information – this has directly led to NICE revising its guidance.”

The updated guidance on total prosthetic replacement of the temporomandibular joint is available to view on the NICE website. It does not make recommendations about whether or not the NHS should fund the procedure, but advises what safeguards should be put in place when carrying out the surgery. NHS Trusts are expected to consider the guidance when deciding whether or not to fund the procedure locally.

Ends

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Notes to Editors

Explanation of terms

  1. The temporomandibular joint is a type of ‘hinge’ between the temporal bone (at the base of the skull) and the lower jaw. Temporomandibular joint disorders affect this joint. Symptoms can include pain, difficulty opening the mouth and sometimes even sensitivity to sound or dizziness (due to the closeness of the joint to the ear).
  2. NICE’s Interventional Procedures (IP) guidance makes recommendations on the safety of a procedure and how well it works, not on whether or not it should be routinely funded. This type of NICE guidance is applicable for NHS healthcare settings in England, Wales, Scotland and Northern Ireland.

Interventional procedures guidance is developed for NICE by an independent committee of experts. It assesses the available evidence and will generally make one of the following main recommendations for the use of the procedure:

  • Use with normal arrangements for clinical governance, consent and audit.
  • Use with special arrangements for clinical governance, consent and audit or research.
  • Use only in research.
  • Do not use.

An interventional procedure is a test, treatment or surgery that involves a cut or puncture of the skin, or an endoscope to look inside the body, or energy sources such as X-rays, heat or ultrasound.

  1. Al-Jundi et al, 2008.
  2. The previous guidance, published in 2009, recommended that:
  • Current evidence on the efficacy of total prosthetic replacement of the temporomandibular joint (TMJ) in the short and medium term is adequate, but the quantity of evidence on long-term efficacy and on safety is inadequate. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research.
  • Clinicians wishing to undertake total prosthetic replacement of the TMJ should take the following actions:
    • Inform the clinical governance leads in their Trusts.
    • Ensure that patients and/or their parents/carers understand the uncertainty about the procedure's safety and efficacy and provide them with clear written information. In addition, the use of NICE's information for patients is recommended.
    • Audit and review clinical outcomes of all patients having total prosthetic replacement of the TMJ.
    • Patient selection should be carried out in specialist units by a team with regular practice and specialist expertise in the conservative and surgical management of TMJ problems, and should include consideration of all relevant surgical and medical options. The British Association of Oral and Maxillofacial Surgeons has produced guidelines on patient selection.
    • The procedure should be carried out only by surgeons with specific training and experience in total prosthetic replacement of the TMJ.
    • NICE encourages clinicians to collect data on all patients with the aim of providing further evidence on safety and longer-term efficacy. NICE may review the procedure on publication of further evidence.

About the guidance

  1. The guidance will be available at http://www.nice.org.uk/guidance/IPG500 from Wednesday 27 August 2014. Embargoed copies of the draft guidance are available from the NICE press office on request.

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We’re pleased that specialists took notice of our recommendation and recorded this information – this has directly led to NICE revising its guidance.

Professor Bruce Campbell, Chair of the Interventional Procedures Advisory Committee at NICE