Botox for TMJ disorders may not lead to bone loss in the short term, but
more research is needed

Date:
September 14, 2020
Source:
New York University
Summary:
Botox injections to manage jaw and facial pain do not result in
clinically significant changes in jaw bone when used short term
and in low doses, according to researchers. However, they found
evidence of bone loss when higher doses were used.



FULL STORY ========================================================================== Botox injections to manage jaw and facial pain do not result in clinically significant changes in jaw bone when used short term and in low doses, according to researchers at NYU College of Dentistry. However, they
found evidence of bone loss when higher doses were used.


==========================================================================
The researchers, whose findings are published in the Journal of Oral
Health Rehabilitation, call for further clinical studies to track bone-
and muscle- related changes with long-term use of Botox for TMJD, or temporomandibular muscle and joint disorders.

TMJDs are a group of common pain conditions that occur in the jaw
joint and surrounding muscles, with the most common type involving the
muscles responsible for chewing. While many individuals manage their
TMJD symptoms with conservative treatments such as jaw exercises, oral appliances, dietary changes, and pain medication, some do not respond
to these treatments.

Botox (or botulinum toxin), an FDA-approved injectable drug known for
its wrinkle-reducing capabilities, is approved to treat certain muscle
and pain disorders, including migraines. It works in part by temporarily paralyzing or weakening muscles. In the U.S., a Phase 3 clinical trial
is currently underway to study the use of Botox to treat TMJD, but in
the meantime, it is increasingly being used off-label.

Thus far, small studies using Botox to treat TMJD in humans have had
mixed results. In animal studies, Botox injections in jaw muscles have
led to major bone loss in the jaw. This is thought to be due to the
muscles not being used to exert force needed for bone remodeling, but
Botox may also have a direct effect on bone resorption, the process of
breaking down bone tissue.

"Given these concerning findings from animal studies, and the limited
findings from clinical studies, more research on the safety of Botox
for jaw muscles and bones is critically important," said Karen Raphael, professor in the Department of Oral and Maxillofacial Pathology, Radiology
and Medicine at NYU College of Dentistry and the study's lead author.

The NYU study included 79 women with TMJD affecting their facial muscles:
35 of whom received Botox injections (between two and five rounds in
the past year) and 44 who were not treated with Botox but may have used
other TMJD treatments.

Using specialized CT scans, the researchers measured participants'
jaw bone density and volume.

The researchers found that jaw bone density and volume were similar
between women who had Botox injections to treat their TMJD and those
who did not. While most study participants were given relatively low
doses of Botox -- smaller than in most clinical trials for TMJD --
individuals who received higher doses of Botox were more likely to have
lower bone density.

Raphael and her colleagues recommend that more human studies be conducted
to better understand the impact of the long-term use of Botox on jaw
muscles and bones -- and whether it just reduces muscle force on bone
or also plays a direct role in altering bone resorption.

"Should Botox receive regulatory approval for the treatment of TMJD,
we would recommend that a phase IV study be done using low-radiation
CT and MRI to track bone- and muscle-related changes with Botox use,
examining both dose and long- term use," said Raphael. "Unless specialized imaging of muscle and bone are conducted among patients who receive Botox treatment over long periods, true cumulative effects will remain unknown."

========================================================================== Story Source: Materials provided by New_York_University. Note: Content
may be edited for style and length.


========================================================================== Journal Reference:
1. Karen G. Raphael, Malvin N. Janal, Aditya Tadinada, Vivian Santiago,
David A. Sirois, Alan G. Lurie. Effect of Multiple Injections of
Botulinum Toxin into Painful Masticatory Muscles on Bone Density
in the Temporomandibular Complex. Journal of Oral Rehabilitation,
2020; DOI: 10.1111/joor.13087 ==========================================================================

Link to news story: https://www.sciencedaily.com/releases/2020/09/200914131910.htm

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