Use of Polysomnography and Onabotulinum Toxin Type A (BOTOX®) in the Treatment of Nocturnal (Sleep Related) Bruxism with Associated Craniofacial Pain: A Pilot Trial

Objective: Nocturnal bruxism, the repetitive grinding, clenching, and chewing movements of the jaw during sleep, can occur in both children and adults. Case series and anecdotal reports suggest that botulinum toxin type A injection may provide effective treatment of nocturnal bruxism and its sequelae. Open-label trials for patients with nocturnal bruxism indicate that it may confer reduction in pain medication use and migraine headache frequency. This study is an open label, pilot study to establish 'proof of principle' for the use of Onabotulinum toxin A (BOTOX, Allergan) to treat nocturnal bruxism with associated craniofacial pain. Methods: Five consenting subjects with nocturnal bruxism and craniofacial pain who have tried dental prosthetics, and have failed trials of at least two prophylactic headache medications were enrolled. Four completed the trial. No serious adverse events were experienced by any subject. The primary outcome measure of this study was the change in number of EMG bursts in the temporalis and masseter muscles as measured during nocturnal polysomnography in an accredited sleep laboratory. Polysomnograms were administered once for baseline measurement and at weeks 4, and 8 after injection of 100-150 U of Onabotulinum Toxin A (BOTOX, Allergan) in a fixed site pattern including temporalis and masseter muscles. Results: Average number of bruxism events decreased through Week 4 after treatment. One of four participants' polysomnograph showed consistent decrease inbruxism events in the weeks following treatment but overall the trends did not reach statistical significance. Secondary outcome measures which demonstrated a trend for improvement included bed partner survey of bruxing activity and sleep interruption, and daily subject craniofacial pain diary. MIDAS scores showed statistical improvement at week 4 after injection. Sleep efficiency and percent rapid eye movement (REM) sleep on polysomnograms demonstrated a trend towards improvement after injection but did not reach statistical significance.