#199 The Truth About Botox and Temporomandibular Joint Disorder

One of the most recent misguided and Ill-advised effort within the past few years to treat Temporomandibular Joint Disorder (TMD) has been funded by the makers of Botox, the most common trade name for Ona botulinum Toxin A.  As most are aware, Botox has been used for decades as an adjunct treatment for facial rejuvenation and wrinkle (rhytid) removal.  By injecting Botox through the skin and into the muscles which animate the face, the underlying muscle is paralyzed, limiting facial animation and wrinkle formation. This mechanism has been cleared by the FDA for this purpose. 

However, the maker of Botox has taken their success in facial rejuvenation an unwarranted step further by proclaiming that paralyzing the muscles of mastication (muscles that move the jaws) is the preferred treatment for TMD.  In order to reinforce this claim, the company, Allergan Esthetics, is spending millions of advertisings and promotional dollars to convince dentists to use the drug for patients complaining of TMD symptoms. The dentists and dental specialists (orthodontists, oral and maxillofacial surgeons, periodontists, and the new and ill-defined oral/facial pain specialists) have accepted these promotions with glee as a spectacular method to improve their practice revenue.  The nationwide average cost for treating TMD with Botox typically ranges from $400 to $1,000 per session. However, depending on the severity of your symptoms and where you live, the overall range stretches from $300 to $2,000+ per treatment.  Considering that injections of Botox are only effective for between 3 and 6 months, it is normal for a patient to expect to pay thousands of dollars for treatment over a relatively short period of time.  I have one patient who showed me receipts totaling $200,000 paid over 10 years for Botox injections for her TMJ pain as she sat in my chair asking for my help relieving her TMD symptoms. 

Additionally, Botox is not currently FDA-approved to treat Temporomandibular Disorder (TMD) or TMJ issues. [1, 2]   It is used “off-label” by doctors and dentists. Off-label means that while the drug is thoroughly approved for other conditions, the FDA has not officially certified its safety and effectiveness for this specific use. [1, 2, 3, 4]   When used Off-Label, both the patient and treating provider are doing so without government approval and fully responsible and liable for complications that arise.  The most common complication is unplanned facial paralysis. 

To counteract the unjustified and dangerous use of Botox for the treatment of TMD, the American Association of Oral and Maxillofacial Surgeons published a well-documented peer reviewed article entitled “Does the Use of Botulinum Toxin in Treatment of Myofascial Pain Disorder of the Masseters and Temporalis Muscles Reduce Pain, Improve Function, or Enhance Quality of Life?” published in the April 2024 Journal of Oral and Maxillofacial Surgery, 82(4):393–401. This was a multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial, the type of study generally considered strong evidence for determining whether a treatment itself works. In this study the researchers compared Ona Botulinum Toxin A (Botox) against a placebo injection of saline (salt solution). 

This study proved statistically that Botox did not reduce pain significantly more than the placebo injection.  Botox failed to outperform the control procedure, which consisted of identical intramuscular injections of saline. Simply stated, Botox and saline got the same results. 

1. Freund B, Schwartz M, Symington JM. The use of botulinum toxin for the treatment of

temporomandibular disorders: Preliminary findings. J Oral Maxillofac Surg 57:916–921, 1999 

[PubMed: 10437718] 

2. Gerwin RD. Classification, epidemiology, and natural history of myofascial pain syndrome. Curr

Pain Headache Rep 5:412–420, 2001 [PubMed: 11560806] 

3. Freund B, Schwartz M, Symington JM. Botulinum toxin: New treatment for temporomandibular

disorders. Br J Oral Maxillofac Surg 38:466–471, 2000 [PubMed: 11010775] 

4. Connelly ST, Myung J, Gupta R, et al. Clinical outcomes of Botox injections for chronic

temporomandibular disorders: Do we understand how Botox works on muscle, pain, and the brain? 

Int J Oral Maxillofac Surg 3:322–327, 2017 

Both Botox and saline reduced TMJ pain by only 34%,  while Botox injections have to be repeated every 3-6 months.  There was no significant difference between the two for pain relief, jaw function, mouth opening, and quality of life.