Short-term use of low doses of Botox to manage jaw and facial pain did not result in significant changes in jaw bone, according to the results of a paper recently published by researchers at the NYU College of Dentistry.
The researchers, whose findings are published in the Journal of Oral Health Rehabilitation, call for more studies to track bone- and muscle-related changes with long-term use of Botox for temporomandibular muscle and joint disorders.
Botox, an FDA-approved injectable drug perhaps best known for its wrinkle-reducing capabilities, is approved to treat certain muscle and pain disorders, including migraines. A U.S.-based Phase 3 clinical trial is underway using Botox to treat TMJD, according to an NYU news release.
Previous studies using Botox to treat TMJD in humans have had mixed results, according to the release. In animal studies, Botox injections in jaw muscles have led to major bone loss in the jaw.
“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, Ph. D., professor in the Department of Oral and Maxillofacial Pathology, Radiology and Medicine at the NYU College of Dentistry and the study’s lead author.
According to the news release, the researchers found comparable jaw bone density and volume in women who had Botox injections to treat their TMJD and those who did not.
“Should Botox receive regulatory approval for the treatment of TMJD, we would recommend that a phase 4 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 Dr. Raphael in the release. “Unless specialized imaging of muscle and bone are conducted among patients who receive Botox treatment over long periods, true cumulative effects will remain unknown.”