Authors:
Seung Jin Lee, DDS, MSD
Willard D. McCall, Jr., PhD
Young Ku Kim, DDS, PhD
Sung Chang Chung, DDS, PhD
Jin Woo Chung, DDS, PhD
Affiliations:
From the Department of Oral
Medicine and Oral Diagnosis (SJL,
YKK, SCC, JWC), School of Dentistry
and Dental Research Institute, Seoul
National University, Seoul, Korea;
and Department of Oral Diagnostic
Sciences (WDM), School of Dental
Medicine, University at Buffalo,
Buffalo, New York.
Correspondence:
All correspondence and requests for
reprints should be addressed to Jin
Woo Chung, DDS, PhD, Department
of Oral Medicine and Oral Diagnosis,
School of Dentistry and Dental
Research Institute, Seoul National
University, 28 Yunkeun-Dong,
Chongro-Ku, Seoul 110-749, Korea.
Disclosures:
This research was supported by Seoul
National University’s financial support
for the new faculty (Grant number
850-2003-0096). A preliminary report
was presented at Society for
Neuroscience Annual Meeting, 2005.
0894-9115/10/8901-0016/0
American Journal of Physical
Medicine & Rehabilitation
Copyright © 2009 by Lippincott
Williams & Wilkins
DOI: 10.1097/PHM.0b013e3181bc0c78
16
Am J Phys Med Rehabil 2010;89(1):16-23
2010010006
Electromyography
ORIGINAL RESEARCH ARTICLE
Effect of Botulinum Toxin Injection
on Nocturnal Bruxism
A Randomized Controlled Trial
ABSTRACT
Lee SJ, McCall WD, Jr., Kim YK, Chung SC, Chung JW: Effect of botulinum
toxin injection on nocturnal bruxism: A randomized controlled trial. Am J Phys
Med Rehabil 2010;89:16 –23.
Objective: To evaluate the effect of botulinum toxin type A on noctur-
nal bruxism.
Design: Twelve subjects reporting nocturnal bruxism were recruited
for a double-blind, randomized clinical trial. Six bruxers were injected with
botulinum toxin in both masseters, and six with saline. Nocturnal electro-
myographic activity was recorded in the subject’s natural sleeping envi-
ronment from masseter and temporalis muscles before injection, and 4, 8,
and 12 wks after injection and then used to calculate bruxism events.
Bruxism symptoms were investigated using questionnaires.
Results: Bruxism events in the masseter muscle decreased signifi-
cantly in the botulinum toxin injection group (P ⫽ 0.027). In the tempo-
ralis muscle, bruxism events did not differ between groups or among
times. Subjective bruxism symptoms decreased in both groups after
injection (P ⬍ 0.001).
Conclusions: Our results suggest that botulinum toxin injection re-
duced the number of bruxism events, most likely mediated its effect
through a decrease in muscle activity rather than the central nervous
system. We controlled for placebo effects by randomizing the interven-
tions between groups, obtaining subjective and objective outcome mea-
sures, using the temporalis muscle as a control, and collecting data at
three postinjection times. Our controlled study supports the use of botu-
linum toxin injection as an effective treatment for nocturnal bruxism.
Key Words: Electromyography, Masseter Muscle, Temporalis Muscle, Randomized
Controlled Trial
Am. J. Phys. Med. Rehabil. ● Vol. 89, No. 1, January 2010
THIS MATERIAL MAY BE
PROTECTED BY COPYRIGHT
LAW (17 USC)
B ruxism has been defined as an oral habit con-
sisting of involuntary rhythmic or spasmodic non-
functional gnashing, grinding, or clenching of teeth.1
Bruxism is a very common condition in the general
population. About 85%–90% of the general popula-
tion reports bruxism to some degree during a life
time.2 The prevalence of chronic nocturnal bruxism
ranges from 20% to 25% in children,3 5%– 8% in the
adult population,4,5 and 3% in the elderly.5
Although factors such as emotional stress,
neurologic disorders, medications, and occlusal in-
terferences have been proposed,6,7 both the etiol-
ogy and pathophysiology of bruxism are still un-
clear. Bruxism seems to have a multifactorial
etiology and to be centrally mediated.8
According to the American Sleep Disorders As-
sociation, the diagnosis of nocturnal bruxism is based
on the reports of tooth grinding or clenching and one
of the following signs: abnormal tooth wear, sounds
associated with bruxism, and jaw muscle discomfort.4
Research measurement of bruxism has used electro-
myographic (EMG) activity of masticatory muscles by
either portable electromyography or polysomnogra-
phy. Fully instrumented laboratory-based nocturnal
polysomnographic study allows multidimensional
analyses of sleep-related physiologic behaviors but
requires the subjects to sleep in an unfamiliar sleep
laboratory environment. Alternatively, portable EMG
recording devices enable recordings in the subject’s
home environment with minimum expense.9 We
elected to use the portable EMG device described in
the Methods section.
Previous bruxism studies using EMG recording
devices have used various criteria to define brux-
ism.9 –11 Recently, Haketa et al.9 reported a semiau-
tomated computer method that reduced error, de-
creased analysis time, and had high interexaminer
reliability of the EMG-based analyses. Based on these
considerations, their method was selected. The frac-
tion of maximum voluntary contraction (MVC) used
as the threshold for an EMG bruxism event (defined
in Methods) will affect the number of EMG bruxism
events detected. Fractions such as 3%, 5%, 10%, and
20% MVC have been used.9 –11 A higher fraction helps
to reduce spurious EMG events resulting from talk-
ing, blowing air, or other nonclenching low-level
activities. Hence, 20% MVC was selected to underes-
timate rather than overestimate the number of EMG
events.
Various treatment modalities such as occlusal
splints, pharmacologic agents such as benzodiaz-
epine or L-dopa, and psychobehavioral therapy have
been investigated for the management of bruxism,
but none is reported to be fully effective.12,13 Re-
cently, locally injected botulinum toxin has been
used in various movement disorders,14 –22 but its
usefulness and objective effects on nocturnal brux-
www.ajpmr.com
ism have not been evaluated using objective mea-
sures such as EMG activity. Moreover, these studies
often lacked one or more controls such as a placebo
injection or an uninjected muscle (Table 1).
The aims of this study were to evaluate the
effect of injection of botulinum toxin A into the
masseter muscle on nocturnal bruxism using a
portable EMG device, on the differences between
masseter and temporalis muscle in the EMG brux-
ism activity, and on the changes in the subjective
bruxism symptoms. We hypothesized that in the
botulinum toxin-injected group the number of
EMG bruxism events would decrease in the masse-
ter muscle compared with the temporalis muscle
and that the subjective bruxism changes would
decrease.
METHODS
Subjects
An advertisement was distributed to the fac-
ulty, staff, and students of Seoul National Univer-
sity Dental Hospital requesting volunteers who re-
ported that they were tooth grinders, otherwise
healthy, and aged 20 –30 yrs. The subjects were
recruited from those who responded.
Exclusion criteria were temporomandibular
disorders, pain in the orofacial region, insomnia,
known botulinum toxin allergy,23,24 pregnancy,
neuromuscular disease, bleeding disorders, antibi-
otic therapy use, pulmonary disease that produced
coughing during sleep, or infectious skin lesion at
the site of the injection.
Seven men and five women with nocturnal
bruxism participated in this study. The mean ages
were 25.0 ⫾ 2.35 yrs for men and 24.8 ⫾ 0.83 yrs
for women. The study was approved by an institu-
tional review board (an ethical committee imple-
menting the Korean equivalent of the Declaration
of Helsinki), and informed consent was obtained
from each subject. The subjects were randomly
assigned to control (24.8 ⫾ 1.47 yrs, 4 men and 2
women) and botulinum toxin injection groups
(25.0 ⫾ 2.28 yrs, 3 men and 3 women).
Equipment and Instruments
A bruxism symptom questionnaire to evaluate
the subjective bruxism symptoms consisted of
three items: (1) How often do you think that you
had bruxed at night during the past 1 mo? (2) How
often have you heard from your sleeping partner
that you bruxed during the past 1 mo? (3) How
often during the past month have you felt jaw
stiffness on waking? The responses to each item
were based on a 0 –5 scale where 0 ⫽ none, 1 ⫽
very seldom, 2 ⫽ seldom, 3 ⫽ often (half the
mornings), 4 ⫽ very often, 5 ⫽ every day. The
rationale was that previous reports have used sub-
Effect of Botulinum Toxin on Nocturnal Bruxism 17
18
Lee et al.
TABLE 1 Summary of previous reports using botulinum toxin to treat bruxism14 –22
Muscle Sample Control Duration of Dose/Muscle
Citation Injected Bruxism Origin Size Group Effect, wks Toxin Type (MU)a Outcome Measure Outcome

Van Zandijcke Masseter and Brain injury 1 No 12 BTX-A (brand name 1st: 25; 2nd: 25 Clinical observation Marked reduction
et al.14 temporalis not given) (at 2 wks)
Ivanhoe Masseter and Brain injury 1 No 12 BTX-A (brand name 50 Clinical observation Remained free of bruxism
et al.15 temporalis not given)
Watts et al.16 Masseter Cranial-cervical 12 No 13 BTX-A (Brand name 50 Subjective symptom 67% subjects reported
dystonia not given) improvement
Tan and Masseter Not stated 18 No 19.1 ⫾ 17.0 Botox 61.7 ⫾ 11.1 Subjective symptom Significant improvement
Jankovic17
Pidcock Masseter Brain injury 1 No 8 Botox 1st: 15; 2nd: 15 Clinical observation Persistent suppression
et al.18 (at 2 mos)
See and Tan19 Masseter Amphetamine 1 No 12–16 Dysport 50 Subjective symptom Significant improvement
induced
Nash et al.20 Masseter and Huntington’s 1 No 12–24 BTX-A (brand name 25–50 Subjective symptom Improvement
temporalis disease not given)
Monroy and da Masseter Autism 1 No 8 Botox 15 Clinical observation Improvement
Fonseca21

Am. J. Phys. Med. Rehabil.

Guarda-Nardini Masseter and Not stated 10 ⫹ 10 Yes 24 Botox 20 (temporalis) Subjective efficacy Significant difference

●
et al.22 temporalis 30 (masseter)
a
One mouse unit (MU) of Botox is clinically equivalent to ⬃3 MU of Dysport. Thus, when the brand name is not given, one is unsure of the dose.

Vol. 89, No. 1, January 2010

jective measures, and we wished to compare our
results with the previous data.
The test-retest reliability of the questionnaire
with a 2-wk time interval was assessed on eight
subjects before this study. The ␬ index for each of
the three questions ranged from 0.52 to 0.74.
Hence, the agreement was moderate to substantial.
EMG signals were recorded with a Myomonitor
EMG system (Delsys Inc, Boston, MA) with a four-
channel, HP Jornada 720 Handheld Computer, and
Myomonitor WinCE software. The recorded signals
were amplified then sampled at 1024 Hz. The ac-
quired data were analyzed with Myomonitor software.
Procedure
Several procedures were performed before the
injection. Each subject completed the bruxism
questionnaire. The subjects were asked to clench as
hard as they could, and the EMG activity was re-
corded for 3 secs. This clench procedure was re-
peated three times. Off-line each 3-sec recording
was converted to a series of root mean square
values described later. The maximal value within
each 3-sec clench was obtained, and the three val-
ues were averaged.
The subjects were instructed and trained on
the use of the portable EMG machine, so that they
could record data with it at home. The EMG data of
both masseter and temporalis muscles were col-
lected for three consecutive nights at home for an
average of 6 hrs per night for each subject. If the
electrodes became detached during the recording,
EMG data were recorded for an additional night.
The processing of these data is explained below.
Subjects were randomly assigned to either the
botulinum toxin injection group or the saline in-
jection group. For the experimental group, 80
mouse units of botulinum toxin A (Dysport, Ipsen,
Wrexham, United Kingdom) were diluted in 0.8 ml
of saline. For the control group, 0.8 ml of saline
was used. Botulinum toxin or saline was injected
into each subject’s masseter muscles at three sites.
The first site was the inferior, prominent part of the
masseter muscle observed when the subject was
asked to clench, and the other two sites were 5 mm
from the first point anteriorly and posteriorly. Sub-
jects and operators were blind to the material in-
jected, and the persons collecting the data were
blind to the group membership of the subjects.
At 4, 8, and 12 wks after the injection, each
subject completed the bruxism symptom question-
naire, and EMG data were collected for two con-
secutive nights as described earlier.
Data Processing and Statistics
The EMG data from each recordings of night
were converted to root mean square values. The
segment of time over which the root mean square
www.ajpmr.com
value was computed was 0.125 sec, and the overlap
of time segments was 0.0625 sec. From these data,
the number of bruxism events per hour was calcu-
lated using the criteria of Haketa et al.9: (1) a root
mean square EMG amplitude above the 20% MVC
level, (2) events with duration longer than 2 secs,
and (3) the interval between each separate event
were longer than 2 secs. These criteria have been
shown to avoid signals from talking, blowing air, or
other nonclenching low-level activities. Data re-
ported are the average of the EMG activity from all
of the nights available. As mentioned in the Intro-
duction, various fractions of MVC have been used
as the threshold to define an EMG bruxism event.
To see how important this threshold might be, the
data were also analyzed using 10% MVC as the
threshold for a bruxism event.
The design of this research has three factors:
muscle (masseter and temporalis), time (preinjec-
tion: 4, 8, and 12 wks), and group (botulinum toxin
injection and saline injection). The multivariate
repeated-measures statistical tests give results for
main effects (muscle, time, and group), interac-
tions of pairs of the three main effects, and an
interaction of all three effects (muscle by time by
group). If the interactions are significant, one pro-
ceeds to post hoc contrasts of the cells.
The within-subjects nature of our research de-
sign led to some not-so-simple statistical hypothe-
ses. First, the main effect for group is not expected
to be significant because this test includes both
groups before injection where no group difference
is expected, and it also includes the temporalis
muscle in both groups where no difference is ex-
pected. Second, the main effect for time is not
predicted to be significant because it includes both
the masseter (expected to change) and the tempo-
ralis (not expected to change) muscles. Thus, we
expect the interaction tests, which isolate the mas-
seter from the temporalis muscles and isolate the
preinjection from the postinjection times, to reveal
the effect of the botulinum toxin.
Post hoc testing with Helmert contrasts was
performed to compare preinjection with postinjec-
tion times. The Helmert contrasts compare the
current cell with the average of the subsequent
cells. Hence, the first Helmert contrast would com-
pare the preinjection mean with the average of the
4-, 8-, and 12-wk means. (We predict this one to be
significant.) The second Helmert contrast would
compare the 4-wk mean with the average of the 8-
and 12-wk means, and the third Helmert contrast
would compare the 8- and 12-wk means. (We
would not expect these latter two to be significant.)
To investigate bruxism scores from the symp-
tom questionnaire, an analysis of variance involv-
ing time and group was used. Time was treated as
Effect of Botulinum Toxin on Nocturnal Bruxism 19
 TABLE 2 Number of EMG bruxism events per hour during sleep using the 20% MVC criterion
Muscle Group Before 4 wks 8 wks 12 wks

Masseter Botulinum toxin 2.77 ⫾ 1.86 0.15 ⫾ 0.29 0.26 ⫾ 0.35 0.26 ⫾ 0.24
Saline 2.48 ⫾ 1.26 2.24 ⫾ 1.06 2.50 ⫾ 1.37 2.66 ⫾ 1.44
Temporalis Botulinum toxin 2.28 ⫾ 1.21 2.51 ⫾ 2.49 2.25 ⫾ 0.77 1.89 ⫾ 1.03
Saline 1.81 ⫾ 1.52 1.85 ⫾ 1.64 2.01 ⫾ 1.64 1.70 ⫾ 1.52
Muscle ⫻ time ⫻ group: F ⫽ 3.523, df ⫽ 2.325, 23.252; P ⫽ 0.027. Muscle ⫻ time: F ⫽ 4.507, df ⫽ 2.325, 23.252; P ⫽ 0.010.
Muscle ⫻ group: F ⫽ 4.384, df ⫽ 1, 10; P ⫽ 0.063. Time ⫻ group: F ⫽ 4.118, df ⫽ 2.052, 20.523; P ⫽ 0.015. Muscle: F ⫽ 0.602,
df ⫽ 1, 10; P ⫽ 0.456. Time: F ⫽ 3.763, df ⫽ 2.052, 20.523; P ⫽ 0.021. Group: F ⫽ 1.625, df ⫽ 1, 10; P ⫽ 0.231. Post hoc
Helmert contrast for time, preinjection vs. postinjection: F ⫽ 8.151, df ⫽ 1, 10; P ⫽ 0.015. Post hoc Helmert contrast for time,
4 wks vs. average of 8 and 12 wks: F ⫽ 0, df ⫽ 1, 10; P ⫽ 0.515. Post hoc Helmert contrast for time, 8 wks vs. 12 wks: F ⫽
0.455, df ⫽ 1, 10; P ⫽ 0.612.

a repeated measure and group as a between-sub-
jects measure.
RESULTS
No subjects withdrew from our study, and no
adverse events were reported. No subjects reported
any dry mouth symptoms, which suggests that the
botulinum toxin was not injected into the parotid
gland.
EMG Bruxism Events
The number of EMG bruxism events was com-
pared before injection between the first night and
the average of the subsequent two nights, and no
statistical differences were found (paired t test, P ⬎
0.2). Hence, data from all three nights were pooled
for the preinjection data and for both nights for the
postinjection data.
The number of EMG bruxism events (Table 2)
decreased after the botulinum toxin injection in
the masseter muscle but not in the temporalis
muscle and did not seem to differ in the three
postinjection times. Figure 1 suggests that the
number of EMG events recorded from the masseter
muscle: (1) was roughly the same in both the saline
and botulinum toxin groups preinjection, (2) was
roughly the same before and after injection in the
control group (open squares), (3) was markedly
lower postinjection in the botulinum toxin group
(filled circles), and (4) did not change much in
either group among the three postinjection times.
A three-way analysis of variance (Table 2) us-
ing muscle and time as within-subject factors and
group (injection material) as a between-subjects
factor gave a significant three-way interaction (P ⫽
0.027).
Post hoc testing showed that (1) the postinjec-
tion mean EMG events at 4, 8, and 12 wks did not
differ within any of the four muscle-and-injection
groups (all P ⬎ 0.20) and (2) averaged over the
three postinjection times, the masseter-botulinum
mean (0.23 ⫾ 0.29) was lower (P ⬍ 0.001) than

FIGURE 1 EMG events recorded from the masseter muscle. Preinjection (horizontal axis) and postinjection
(vertical axis) in the control group (open squares) and in the botulinum toxin group (filled circles).
(a) Four weeks. The number of bruxism events was roughly the same pre- and postinjection in the
control group and was lower postinjection in the botulinum toxin group. (b) Eight weeks. (c) Twelve
weeks.

20 Lee et al. Am. J. Phys. Med. Rehabil. ● Vol. 89, No. 1, January 2010
 TABLE 3 Number of EMG bruxism events per hour during sleep using the 10% MVC criterion
Muscle Group Before 4 wks 8 wks 12 wks

Masseter Botulinum toxin 4.97 ⫾ 2.33 0.59 ⫾ 0.57 1.33 ⫾ 1.10 1.70 ⫾ 0.91
Saline 4.70 ⫾ 1.17 4.13 ⫾ 1.31 4.12 ⫾ 0.89 4.40 ⫾ 1.52
Temporalis Botulinum toxin 4.24 ⫾ 2.25 4.40 ⫾ 3.15 4.26 ⫾ 1.67 4.83 ⫾ 2.62
Saline 3.26 ⫾ 1.77 2.96 ⫾ 1.27 3.31 ⫾ 1.84 3.59 ⫾ 2.09
Muscle ⫻ time ⫻ group: F ⫽ 5.186, df ⫽ 1.783, 17.834; P ⫽ 0.019, Greenhouse-Geisser. Muscle ⫻ time: F ⫽ 7.956, df ⫽
1.783, 17.834; P ⫽ 0.004. Muscle ⫻ group: F ⫽ 10.628, df ⫽ 1, 10; P ⫽ 0.009. Time ⫻ group: F ⫽ 3.332, df ⫽ 2.342, 23.418;
P ⫽ 0.047. Muscle: F ⫽ 1.445, df ⫽ 1, 10; P ⫽ 0.257. Time: F ⫽ 6.837, df ⫽ 2.342, 23.418; P ⫽ 0.003. Group: F ⫽ 0.489, df ⫽
1, 10; P ⫽ 0.500. Post hoc Helmert contrast for time, preinjection vs. postinjection: F ⫽ 13.828, df ⫽ 1, 10; P ⫽ 0.004. Post
hoc Helmert contrast for time, 4 wks vs. average of 8 and 12 wks: F ⫽ 2.284, df ⫽ 1, 10; P ⫽ 0.162. Post hoc Helmert contrast
for time, 8 wks vs. 12 wks: F ⫽ 2.331, df ⫽ 1, 10; P ⫽ 0.158.

masseter-saline mean (2.47 ⫾ 1.23) whereas the
temporalis-botulinum mean (2.22 ⫾ 1.54) did not
differ (P ⫽ 0.483) from the temporalis-saline mean
(1.85 ⫾ 1.51). In other words, bruxism events in
the masseter muscle decreased significantly in the
botulinum toxin injection group after the injec-
tion. In the temporalis muscle, bruxism events did
not differ between the groups or among the record-
ing times.
When the data were analyzed using 10% MVC
as the threshold for an EMG bruxism event, the
number of events using the lower threshold in-
creased compared with the 20% MVC threshold,
but the statistical conclusions remained the same
(Table 3).
Bruxism Subjective Scores
The data from the bruxism questionnaire,
where each subject was asked the questions about
bruxism, suggested that the bruxism score de-
creased in both the botulinum toxin and saline
injection groups after injection (Table 4). The in-
teraction between time (before injection and 4, 8,
and 12 wks after injection) and group (botulinum
toxin, saline) was not statistically significant (P ⫽
0.362) nor was the main effect for group (P ⫽
0.269), i.e., the mean for the botulinum-injected
group and the mean for the saline-injected group,
each averaged over the four times, did not differ
significantly. However, the main effect for time was
significant (P ⬍ 0.001), i.e., the means for each
time, where each mean was averaged over both
groups, were not all equal. Post hoc testing with
Helmert contrasts showed that the bruxism score
means, averaged over both groups, decreased sig-
nificantly from pre- to postinjection (P ⫽ 0.006)
but did not differ among the three postinjection
times (all P ⬎ 0.3).
DISCUSSION
The first main finding was that the number of
suprathreshold EMG bruxism events during sleep
significantly decreased in the masseter muscle in
the botulinum toxin injection group compared
with the saline injection group. The number of
bruxism events was markedly reduced at 4 wks
after botulinum toxin injection and maintained for
the 12- wk duration of our study.
The second main finding was that, in contrast
to the decrease in suprathreshold EMG bruxism
events in the masseter muscle injected with botu-
linum toxin, the suprathreshold EMG bruxism
events in the temporalis muscle were remarkably
constant. We interpret these findings as consistent
with bruxism being centrally mediated. Although
we believe that bruxism is centrally mediated, its
effects are manifested in the peripheral muscle
activity, and this study suggests that such periph-
eral activity can be effectively reduced by botuli-
num toxin.
We interpret the results of the three parts of
Figure 1a–c as suggesting that minimal, if any,

TABLE 4 Subjective symptoms of bruxism

Group Before 4 wks 8 wks 12 wks

Botulinum toxin 1.75 ⫾ 0.91 0.75 ⫾ 0.70 0.81 ⫾ 1.08 0.61 ⫾ 0.64
Saline 1.89 ⫾ 0.71 1.33 ⫾ 1.08 1.47 ⫾ 0.93 1.39 ⫾ 1.00
Time ⫻ group: F ⫽ 1.105, df ⫽ 3, 30; P ⫽ 0.362. Group: F ⫽ 1.368, df ⫽ 1, 10; P ⫽ 0.269. Time: F ⫽ 8.315, df ⫽ 3, 30;
P ⬍ 0.001. Post hoc Helmert contrast for time, preinjection vs. postinjection: F ⫽ 11.844, df ⫽ 1, 10; P ⫽ 0.006. Post hoc
Helmert contrast for time, 4 wks vs. average of 8 and 12 wks: F ⫽ 0.065, df ⫽ 1, 10; P ⫽ 0.804. Post hoc Helmert contrast for
time, 8 wks vs. 12 wks: F ⫽ 1.092, df ⫽ 1, 10; P ⫽ 0.321.

www.ajpmr.com Effect of Botulinum Toxin on Nocturnal Bruxism 21

 contractions of facial muscles or other muscles
were detected after the botulinum toxin injection
and that in one subject some small part of the
masseter may not have received sufficient botuli-
num toxin.
Our third main finding was that the subjective
scores from both the botulinum toxin and the saline
injection groups decreased, hence both groups be-
lieved that their bruxism had been reduced. This
finding illustrates the need for a control group, the
need for an objective measurement of bruxism, and
suggests that the blinding of the subjects to the
injection material may have been successful.
Botulinum toxin injection for patients with
bruxism, first described by Van Zandijcke and Mar-
chau,14 has been reported to be an effective treat-
ment.15–22 However, all of the previous studies
used subjects’ subjective symptoms as the only
indicator to assess the therapeutic effect of botuli-
num toxin on bruxism and often failed to include a
control group (Table 1). We used EMG analysis as
an objective measure for evaluating the nocturnal
bruxism, measured the temporalis muscle as a
within-subject control, and included a group where
the injection was saline. Thus, we believe that we
have improved on the controls used previously.
Some studies injected botulinum toxin in both
the masseter and temporalis muscles for severe
bruxism patients,14,15,20,22 whereas other studies
reported that masseter muscle injection alone
could reduce nocturnal bruxism effectively.16 –19,21
Our study showed that the bruxism activity was
significantly reduced after botulinum toxin injec-
tion in the masseter muscle, but the activity still
persisted in the temporalis muscle. It is expected
that injection into the two masticatory muscles
would be more effective than into one muscle.
However, the unfavorable result of an “hourglass
deformity” of the facial region resulting from de-
pression of the temporal area when an equivalent
dose of botulinum toxin was injected in the tem-
poralis was reported in 28% of the subjects in a
previous study.25 Further study about the effective
dose for the temporalis muscle to decrease bruxism
with minimal side effects should be considered.
The injected botulinum toxin is bound to the
cholinergic motor nerve terminal, absorbed into
the cytoplasm of the nerve terminal, and blocks
acetylcholine release. Thus, injection of botulinum
toxin into a muscle causes muscle paralysis.26 We
speculate that decreased action potentials directly,
not muscle atrophy, reduced bruxing events in the
masseter muscle.
The previous studies reporting the effect of
botulinum toxin on bruxism used the equivalent
dose of Dysport units ranging from ⬃45 to 150
units. Our dose was in the middle of this range. All
doses were apparently effective (Table 1).
22 Lee et al. Am. J. Phys. Med. Rehabil.
Four limitations should be made clear. First,
several complications after botulinum toxin injec-
tion into the masticatory muscles have been re-
ported, including mastication difficulties, muscle
pain, speech disturbance, and unnatural facial ap-
pearance. But these complications are reported to
be transient, usually lasting from 1 to 4 wks after
injection.27 Immunologic responses such as aller-
gic skin reactions or formation of antibodies can
occur in a small percentage of subjects.23,28 How-
ever, we did not observe any of these problems in
our sample.
Second, the duration of the effects was nar-
rowly focused because the study ended after 12
wks. Because our main focus was on a well con-
trolled study of the physiologic effects of botuli-
num toxin on the nocturnal bruxing events, the
design did not include the short-term (⬍4 wks)
and very long-term (⬎12 wks) effects. The data in
Figure 1 suggest that the effect of the botulinum
toxin on the EMG activity in the injected masseter
was robust in the time frame we studied. Thus, it
did not reveal the longer term effects as the muscles
regain their innervation. Again, our purpose was to
investigate, in a way we believe was carefully con-
trolled, the effects on bruxism when the botulinum
toxin had paralyzed the muscle. When botulinum
toxin is injected to a striate muscle, paresis occurs
after 2–5 days and lasts 2–3 mos before it gradually
decreases.26 Complete functional recovery is observed
6 mos after the initial injection.29 In a study that
evaluated the effect of botulinum toxin A on severe
bruxism patients,17 the mean total duration of re-
sponse was 19.1 ⫾ 17.0 wks (range, 6 –78 wks). If the
inability to activate the masseter muscle for several
months might be able to modify the bruxing habit,
reduced bruxism would be maintained after the ef-
fective period of botulinum toxin. Further study will
be needed to evaluate the long-term effect of botuli-
num toxin on nocturnal bruxism.
Third, the questionnaire for subjective brux-
ism is not validated. Although the bruxism ques-
tionnaire is reliable, and the questions seem to
have face validity in that they directly ask about
bruxism, there is no validated scale for measuring
bruxism and its severity and no gold standard for
diagnosing bruxism outside the sleep laboratory. A
recent review30 failed to find any validated ques-
tionnaires. Moreover, the absence of an interaction
between time and group for our questionnaire
data, which suggests that the two groups did not
respond differently, suggests that developing vali-
dated index might be difficult.
Fourth, both the number of subjects, six per
group, and the severity of bruxism were modest.
Our sample size, however, was sufficient to reveal a
statistically significant postinjection decrease of
bruxism events in the muscles that were injected
● Vol. 89, No. 1, January 2010
with botulinum toxin, the main aim of the study.
The subjects were recruited from those complain-
ing of bruxism, not from patients seeking treat-
ment in clinic; moreover, the numbers of EMG
bruxism events per hour (1–3 for the 20% MVC
criterion and 2– 8 for the 10% MVC criterion) were
modest. Thus, our subjects were not severe brux-
ers, yet a significant effect was demonstrated.
CONCLUSIONS
Our results showed that the injection of botu-
linum toxin in the masseter muscle reduced the
number of bruxism events during sleep, most likely
mediated through its effect on muscle tone rather
than central nervous system. Botulinum toxin in-
jection can be used as an effective treatment for
nocturnal bruxism.
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Effect of Botulinum Toxin on Nocturnal Bruxism 23