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Metal Implants and Dental Amalgam: The FDA Announces Public Meeting and Paper

The U.S. Food and Drug Administration (FDA) announced a paper on metal-containing implants and a panel meeting as part of ongoing efforts to evaluate materials in medical devices to address potential safety questions.

Drug Induced Bruxism

The authors of this article state that orofacial movement disorders (bruxism) are treated typically by dental professionals and not by those specialists (neurologists) researching and treating the other movement disorders (Parkinson's disease, Huntington's disease, tremors, etc.). Again, this is more evidence of the complexity of TMD and the need for multidisciplinary research and treatment in TMD.

Cervical Muscle Tenderness in Temporomandibular Disorders and Its Associations with Diagnosis, Disease-Related Outcomes, and Comorbid Pain Conditions

To analyze cervical tenderness scores (CTS) in patients with various temporomandibular disorders (TMD) and in controls and to examine associations of CTS with demographic and clinical parameters.

You, Your Esophagus and TMD

The esophagus is a roughly ten-inch hollow tube that descends from your throat through the diaphragm into the stomach. Normally, it is a one-way street transporting food you swallow to the stomach for digestion. But in GERD— Gastroesophageal Reflux Disease— the flow can reverse so that stomach contents (including gastric acids) are regurgitated upwards to cause a burning sensation (heartburn), nausea, pain and other distressing symptoms.

It's Time to Be Part of the Solution

The National Academy of Medicine (NAM) Study on Temporomandibular Disorders (TMD) is well underway. We strongly encourage everyone affected by TMD to write to the NAM committee letting them know what it is like to live with TMD and your experiences with getting care.

Is Botox Safe and Effective for TMD?

  • Sep 24, 2014
As TMJ patients search for alternative treatments to manage their pain, a doctor may have suggested the possibility of trying Botox injections directly into the chewing (masseter and temporalis) muscles to relax these muscles. In addition to its well-publicized cosmetic uses, Botox has been approved by the FDA for painful conditions potentially related to TMJ, such as cervical dystonia and migraine. Of note, Botox is not FDA-approved for use in TMJ disorders. When doctors offer this treatment to TMJ patients, patients should be aware that this is "off-label use" that is not approved by the FDA. The FDA has not evaluated the safety or efficacy of this powerful neurotoxin for TMJ pain treatment. Adding to the uncertainty about whether to pursue treatment of TMJ pain with Botox , clinical trials published so far have been small and have produce inconsistent findings.
 

Before we ask whether Botox can help reduce your TMJ pain, we need to ask a more basic question: Is it safe to use Botox this way? When injected into muscles, Botox causes a partial paralysis of those muscles. The paralysis changes the forces causing normal stress on the TM joint. These forces are considered necessary to maintain the usual process of breakdown and regrowth of bone. If the paralysis changes bone remodeling in the TMJ area, injection of Botox into the chewing muscles might cause unique safety concerns and unknown long-term problems.

 

In an important first step to addressing these concerns, Dr. Susan Herring and her colleagues at the University of Washington in Seattle examined the effect of Botox injections into the jaw muscles of rabbits. In the August 2011 issue of TMJ News Bites, Dr. Herring summarized her findings. She concluded "Botox in the masseter caused an osteoporotic condition in the TMJ of rabbits, raising some concern that this treatment might not be healthy for the joint in the long term."

 

These findings indeed raised concerns, but it was unclear whether findings from a rabbit study had relevance for humans. With the cooperation of the TMJ Association, Dr. Karen Raphael and colleagues at New York University posted an online survey on the Association's website, to identify women who had received TMJ injections in their chewing muscle and a similar group of TMJ patients who did not. Among the 150+ women who completed the survey, Dr. Raphael and colleagues invited a small group of well-matched Botox recipients and nonrecipients, all with TMJ pain, to participate in a study intended to determine whether Dr. Herring's animal findings had relevance for humans. Ultimately, as published in the May 2014 issue of the Journal of Oral Rehabilitation, 7 women who had been treated with Botox for their TMJ pain and 9 matched women who had never received Botox underwent specialized radiological imaging of their TMJs. The images were evaluated by oral and maxillofacial radiologists who did not know their treatment history. The radiologists found abnormally low bone density in the TMJ area in all of the women treated with Botox and in none of the women who did not receive Botox .

 

These findings indicated that more research on the safety of Botox for TMJ pain treatment is essential, to guide both patients and health care providers. We are happy to report that the National Institutes of Dental and Craniofacial Research (NIDCR) of the NIH has provided a grant to Dr. Raphael's team to conduct a much larger study addressing the safety of Botox treatment. If it is found to be a safe treatment when injected in the chewing muscles then, and only then, we can we address broader questions of whether it actually helps reduce the pain of TMJ disorders.

 
Additional Resource: Raphael, K. G., Tadinada, A., Bradshaw, J. M., Janal, M. N., Sirois, D. A., Chan, K. C. and Lurie, A. G. (2014), Osteopenic consequences of botulinum toxin injections in the masticatory muscles: a pilot study. Journal of Oral Rehabilitation. doi: 10.1111/joor.12180 
 
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TMJA1 - Thursday, July 17, 2014
I found the report by Dr. Raphael about studies that seem to show the potential of Botox injections into the masticatory muscles to treat myofascial pain causing decreased bone density in the temporomandibular joint very informative. However, it is important for patients to understand that there are also other reasons why one should be cautious about having such injections (1). It has been shown that some patients who received multiple Botox injections into the temporalis muscle for the treatment of headaches developed so-called disuse atrophy (wasting or loss of muscle tissue), resulting in a disfiguring depression on the side of the head (2). In fact, this adverse effect of Botox injections has actually been used to treat masseteric hypertrophy (bulging masseter muscles), so it could also occur in patients with myofascial pain who have normal-shaped masseter muscles. Secondly, some patients may develop an immune response (antibodies) to Botox that would then block its action and make the injections ineffective. Finally, and perhaps most importantly, such injections are being used to treat the symptoms of myofascial pain but not the cause of the problem, which is an illogical way to approach this situation. Daniel M. Laskin DDS, MS Clinical Advisor, The TMJ Association 1. Botulinum toxin A in the treatment of myofascial pain and dysfunction: the case against its use. Laskin DM. Oral Maxillofac Surg 70; 1240-1242, 2012. 2. Hourglass deformity after botulinum toxin type A injection. Guyuron B et al. Headache 44; 262, 2004.