CLINICAL SCIENCE

Evaluation of various treatment modalities in sleep bruxism

Punit Kumar Singh, MDS,a Habib A. Alvi, MDS,b Balendra Pratap Singh, MDS,c Raghuwar D. Singh, MDS,d
Surya Kant, MD,e Sunit Jurel, MDS,f Kamleshwar Singh, MDS,g Deeksha Arya, MDS,h and Abhishek Dubey, MSci

Sleep bruxism (SB) is a sleep- ABSTRACT

related movement disorder
Statement of problem. Sleep bruxism (SB) is an oral condition that is associated with tooth wear,
characterized by clenching or orofacial pain, and interference with sleep. The most recommended management technique is the
1
grinding of the teeth. The use of an occlusal splint. Although the mandibular advancement device (MAD) has shown good
prevalence of SB is similar in results, few well-designed randomized controlled trials are available with which to compare these
both sexes, with a higher treatment options. Therefore, an evaluation of the effect of these 2 appliances on SB is needed.
prevalence in young adults. Purpose. The purpose of this study was to evaluate the effect of a MAD and a maxillary occlusal
The pathophysiology of SB splint (MOS) on the sleep quality and SB activity of participants with SB.
is debatable, but recent evi-
Material and methods. In this randomized controlled trial, 28 participants were randomly supplied
dence suggests that SB is an
with either a MAD or MOS. The sleep quality of the participants was evaluated with the Pittsburgh
excessive response to micro- Sleep Quality Index (PSQI) and their SB activity with electromyographic activity of the masseter with
2-4
arousals. polysomnography. These variables were measured at baseline, 1 month, and 3 months.
SB is associated with tooth
Results. Of 32 participants, 28 had data available for statistical analysis, as 4 participants did not
wear and orofacial pain.4-7 return for follow-up examination. Both the MOS and MAD significantly reduced the PSQI and SB
Severe SB may even lead to episodes and bursts in participants after 3 months (P<.05). The MAD provided greater reduction
the cracking or fracture of in SB episodes per hour after 3 months compared to the MOS. Participants supplied with a MAD
teeth or the breakage of dental reported more discomfort in their feedback form than participants using a MOS.
restorations. Bruxism is also Conclusions. Both the MAD and MOS provided significantly improved sleep quality and a decrease
related to the sleep quality in SB episodes at 3 months. (J Prosthet Dent 2015;114:426-431)
of patients because micro-
awakenings interferes with sleep.2 Sleep quality can be Among these techniques, the most popular management
evaluated with the Pittsburgh Sleep Quality Index strategy is to use an occlusal splint to prevent the con-
(PSQI).8 sequences of SB and tooth grinding. Many studies have
Currently, no definitive treatment exists for SB. The reported that an occlusal splint significantly reduces SB
following management approaches have been used9: motor activity index (episodes per hour of sleep).10-14
reversible occlusal therapy, occlusal appliances, occlusal Several designs of occlusal splint are available,
treatment with occlusal adjustment, emotional stress including the maxillary occlusal splint (MOS) and the
therapy, physiotherapy, and pharmacologic therapy. mandibular advancement device (MAD), which is an

a
Junior Resident, Department of Prosthodontics, King George’s Medical University UP, Lucknow, India.
b
Professor, Department of Prosthodontics, King George’s Medical University UP, Lucknow, India.
c
Assistant Professor, Department of Prosthodontics, King George’s Medical University UP, Lucknow, India.
d
Associate Professor, Department of Prosthodontics, King George’s Medical University UP, Lucknow, India.
e
Professor, Department of Pulmonary Medicine, King George’s Medical University UP, Lucknow, India.
f
Assistant Professor, Department of Prosthodontics, King George’s Medical University UP, Lucknow, India.
g
Assistant Professor, Department of Prosthodontics, King George’s Medical University UP, Lucknow, India.
h
Associate Professor, Department of Prosthodontics, King George’s Medical University UP, Lucknow, India.
i
Senior Research Fellow, Indian Council of Medical Research, New Delhi, India.

426 THE JOURNAL OF PROSTHETIC DENTISTRY

September 2015
Clinical Implications
The evidence from this study suggests the use of a
mandibular advancement device or maxillary
occlusal splint in individuals with sleep bruxism.
option for the treatment of obstructive sleep apnea and
may be used to reduce SB.15 Most of the previous studies
have reported the use of a MAD in SB but were based on
the Bite Strip (up2dent), which does not discriminate
orofacial activities from SB-related events.15-17 Further-
more, some studies of the MOS have shown contrary
results in patients with SB.18-21 A well-designed ran-
domized controlled trial is needed to evaluate sleep
quality and SB activity by measuring the electromyog-
raphy activity of the masseter with laboratory-based
polysomnography in individuals with SB after random
intervention with either a MAD or MOS.
The purpose of the study was to assess the effect of a
MAD and MOS on the sleep quality and SB scores in
participants with SB. The null hypothesis was that a
MAD or MOS would have no effect on SB.
MATERIAL AND METHODS
In this randomized controlled trial, 50 individuals with
self-reported SB were recruited from the general clinic of
King George’s Medical University (tertiary care hospital),
Lucknow, India. These individuals were then interviewed
and examined clinically, after which 40 participants were
selected on the basis of the following inclusion criteria:
self-reported SB, where tooth grinding sounds had
occurred at least 3 times a week for the past 6 months;
people of either sex aged between 18 and 40 years; and
fewer than 2 missing teeth except for third molars. The
exclusion criteria were as follows: strained or diurnal
bruxers, physical and mental disability that would inter-
fere with the study, and restricted mouth opening (less
than 35 mm). Ethical clearance was granted by the
institutional ethical committee (63rd ECM II-B/P11). All
aspects of the treatment and study were explained to the
participants, who all provided written informed consent.
The 40 participants spent 2 nights in a sleep labora-
tory to confirm the diagnosis of intense and frequent SB.
On the first night, participants were permitted to accli-
matize to the sleep-recording environment; these data
were therefore excluded from statistical analysis. The
second night (baseline) was used to diagnose SB and to
exclude other sleep disorders such as apnea, periodic
limb movement, or epileptiform activity. A diagnosis of
intense SB was based on polysomnographic SB research
diagnostic criteria:22 more than 4 bruxism episodes per
hour, more than 6 bruxism bursts per episode, and/or 25
bruxism bursts per hour of sleep and at least 2 episodes
Singh et al
427
with grinding sounds. All participants were asked to
complete the PSQI, which was used as baseline data.
Of the 40 participants, the 36 individuals who met the
inclusion criteria, including polysomnographic SB
research diagnostic criteria, were enrolled onto the study
(Fig. 1). Block randomization was planned for this study.
In each block, randomization was achieved by computer-
generated chart. Allocation concealment was done by
one of the authors (B.P.S.), who handed over a sealed
envelope containing the name of one of the devices was
handed to the patient. The sealed envelope was opened,
and the device, either a MAD (MAD group) or MOS
(MOS group), was given to the participants by other
authors. Four participants were unable to wear the
appliance because of discomfort. Additionally, 4 partici-
pants did not return for the follow-up examination,
reducing the sample size to 28.
Polysomnographic recording was done by using
laboratory-based polysomnography (S-7000 Cogent
Technology; Embla System Inc) in a sound-attenuated,
temperature-controlled room from approximately 10:30
PM to 7:00 AM or until the participant woke. The elec-
tromyographic (EMG) data were evaluated by one of the
authors (A.D.), who was unaware of the participants’
study groups, and recordings were made according to the
standard technical protocol used in previous SB studies at
the sleep laboratory.3,10,22 To allow for signal recognition
and the calibration of EMG, each participant performed a
series of 5 tasks of 2 seconds’ duration before sleep re-
cordings: voluntary clenching (maximum intercuspal oc-
clusion), lateral and protrusive jaw movements,
swallowing, and coughing. Three levels of voluntary
contractions at maximum (100%), moderate (50%), and
light (approximately 20%) levels were executed in the
maximal intercuspal occlusion. The EMG amplification
was set to avoid signal saturation. EMG signals were
recorded from the bilateral masseter, anterior tibialis, and
unilateral chin muscles by using surface electrodes placed
at their respective positions. All masticatory EMG poten-
tials with an amplitude of at least 20% of the maximum
voluntary contractions were retained to exclude oral motor
activities such as coughing, deglutition, or talking while
sleeping, which could be confused with bruxism in the
EMG. Video recording, focused on the head and neck, was
carried out in parallel with the audio signals to distinguish
SB from nonspecific orofacial activities.23,24 The poly-
somnographic data were analyzed by using software
(Somnologica Studio; Embla Systems Inc).
To fabricate the MADs, casts were mounted on a
semiadjustable articulator (Quickmount 8800; Whip Mix
Corp) at 50% to 75% of maximum protrusion (depending
on the participant’s tolerance) with approximately 6 mm
of interincisal opening.25,26 Two sheets of baseplate wax
(Marc) were each adapted to the maxillary and
mandibular arch covering the occlusal surfaces of all the
THE JOURNAL OF PROSTHETIC DENTISTRY
428
Assessed for eligibility (n=50)
Enrollment
Randomized (n=36)
MAD
Allocated to intervention (n=18)
Received allocated intervention (n=16)
Allocation
Did not receive allocated intervention
(n=2): due to discomfort associated
with appliance; mean
age = 34.50 ±11.05; male=2;
female=0
Lost to follow-up (n=2) : did not
respond; mean age=33.50±10.4;
Follow-up male=1; female=1
Discontinued intervention (n=0)
Analyzed (n=14)
Analysis
Excluded from analysis (n=0)
Figure 1. Flowchart according to CONSORT.
teeth, after which indentations were created on the wax
pattern at the recommended protrusive position. The wax
pattern was processed with heat-polymerizing acrylic
resin (DPI), finished, and polished (Fig. 2).
To fabricate the MOSs, the casts were articulated in
centric relation with approximately 2.5 mm of inter-
occlusal clearance in the first molar region.16 Two sheets
of baseplate wax (Marc) were adapted to the maxillary
arch, and an anterior ramp was created to provide evenly
distributed occlusal contact with the mandibular teeth.
The pattern was processed and then remounted on the
articulator for occlusal adjustments until mutually pro-
tected occlusion was established. The occlusal devices
were finished and polished (Fig. 3).
The appliances were adjusted to fit without discom-
fort. The MOSs were adjusted such that there was
mutually protected occlusion. Instructions were given to
participants regarding the use of the device. The devices
were worn for a period of 2 weeks for habituation.
Throughout this period, participants were regularly fol-
lowed to ensure their comfort with the appliance.16,27
THE JOURNAL OF PROSTHETIC DENTISTRY
Volume 114 Issue 3
Excluded (n=14)
Not meeting inclusion criteria (n=8)
Declined to participate (n=2)
Other reasons (n=4)
MOS
Allocated to intervention (n=18)
Received allocated intervention (n=16)
Did not receive allocated intervention
(n=2): esthetic reason; mean
age=32.50±9.2; male=1; female=1
Lost to follow-up (n=2) : did not
respond or unable to come to
follow-up; mean age=32.50±9.2;
male=1; female=1
Discontinued intervention (n=0)
Analyzed (n=14)
Excluded from analysis (n=0)
The sleep quality of participants was assessed with the
well-validated PSQI.8,28 The questionnaire contains 19
self-rated questions that are combined to form 7
component scores, each of which has a range of 0 to 3
points. The 7 component scores are then added to yield 1
global score, with a range of 0 to 21 points, where 0 in-
dicates no difficulty and 21 indicates severe difficulties in
all areas. The higher the global score the poorer the sleep
quality. The participants were then evaluated for sleep
quality and SB activity (bruxism episodes, bursts, and
episodes with noise) during sleep by using an EMG of
the masseter at 1 and 3 months. The data of sleep quality
and EMG recording at the time of enrollment were used
as the baseline. A feedback assessment was provided
regarding the use of both appliances by writing a
statement.
The categorical variables were compared by the chi-
square test, and continuous variables between the
MAD and MOS were compared by an unpaired t test.
Repeated measures ANOVA was used to compare the
average change from baseline to follow-up (a=.05). The
Singh et al
September 2015 429

Figure 2. Mandibular advancement device. Figure 3. Maxillary occlusal splint.

age and body mass index (BMI) were tested as covariates Table 1. Distribution of participants
in the model. The analyses were carried out with statis- Characteristic MAD MOS P
tical software (SPSS v16.0; IBM Corp). Mean age (y) 38.13 ±11.05 31.31 ±9.4 .09a
Sex (%) .06b
Male 71.4 57.1
RESULTS
Female 28.6 42.9
Table 1 shows the sociodemographic characteristic of all Weight (kg) 73.96 ±7.39 71.16 ±5.56 .27a
participants. The mean level of number of episodes per Height (cm) 167.6 ±6.62 172.62 ±5.90 .06a
hour was found to be significant (P<.001) between the BMI (kg/m )2
26.45 ±4.24 23.94 ±2.31 .06a
29
MAD (1.66 ±0.21) and MOS (3.60 ±0.55) groups at 3 Socioeconomic status (total score), %
months, assuming a 5% significance level and 14 par- Upper lower (5-10) 21.4 0 .06b

ticipants as the sample size; the power of the study was
found to be 99%.
The repeated measures ANOVA revealed a significant
decrease (P<.001) in the PSQI global score over time. A
significant (P=.004) effect was found between the group
and time period on the PSQI global score. The addition
of age and BMI as covariates in the model revealed no
significant (P>.05) effect of age and BMI on the change in
the PSQI global score (Table 2).
A significant (P<.001) effect was found in terms of the
time in the decrease in episode, burst, and episode with
noise. A significant effect of group by time interaction
was observed for episode (P=.002) and burst (P=.04).
However, no significant (P>.05) effect was found for
group by time interaction on episodes with noise. The
covariate analysis of age and BMI did not affect (P>.05)
the change in episode, burst, and episode with noise
(Table 3). The feedback assessment given by participants
stated that the MOS was easy to use, though the MAD
was subjectively more beneficial.
DISCUSSION
The MAD and MOS both led to a significant improve-
ment in sleep quality and a significant reduction in the
mean number of episodes per hour at 3 months
compared to baseline (P<.001). Therefore, the null hy-
pothesis was rejected.
Lower middle (11-15) 21.4 71.4
Upper middle (16-25) 57.1 28.6
MAD, mandibular advancement device; MOS, maxillary occlusal splint; BMI, body mass index.
a
Unpaired t test.
b
Chi-square test.
The study sample consisted of 28 participants, which
is similar to other recent studies on bruxism, supporting
its external validity.19,21,28 The mean age of the partici-
pants was 38.3 ±11.05 years in the MAD group and 31.31
±9.4 years in the MOS group, which is similar to previous
studies.11,16,24 Other studies have reported the propor-
tion of men to women with bruxism to be 50%; however,
in our study, the proportion of men was higher in both
the MAD (71.4%) and MOS (57.1%) groups (Table 1).
The sample was composed of young adults in good
general health and without extreme height, weight, or
BMI values. Further, because of the short span of the
study, any changes in these variables were unlikely.
Participants assigned to both the MAD and MOS
groups showed a significant improvement in sleep
quality (Table 2). This improvement might be attributed
to a reduction in microarousals, leading to reduction in
bruxism episodes.2,4,30 Mainieri et al31 and Saueressig
et al15 also reported a significant improvement in sleep
quality in patients with SB. However, they used ther-
moplastic monoblock MADs and the Toronto sleep
assessment questionnaire to evaluate sleep quality.

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430 Volume 114 Issue 3

Table 2. Comparison of PSQI global score from baseline to 1 and 3 Table 3. Comparison of number of episodes per hour, bursts per
months episode, and episodes with noise from baseline to 1 and 3 months
Characteristic MAD MOS Pa Characteristic MAD MOS Pa
Baseline 11.20 ±2.11 10.07 ±1.18 .10 Episode
1 mo 8.00 ±1.49 7.80 ±1.22 .74 Baseline 7.96 ±1.59 7.18 ±1.09 .15
3 mo 5.60 ±0.51 6.40 ±1.07 .05 1 mo 5.11 ±1.19 5.00 ±1.10 .81
Pb 3 mo 1.66 ±0.21 3.60 ±.55 <.001*
Time <.001* P valueb
Group×time interaction .004* Time <.001*

PSQI, Pittsburgh Sleep Quality Index; MAD, mandibular advancement device; MOS, maxillary Group×time interaction .002*
occlusal splint. Burst
a
Unpaired t test.
b Baseline 53.94 ±11.29 53.84 ±12.10 .50
Repeated measures ANOVA.
*Statistically significant. 1 mo 27.10 ±7.46 29.14 ±8.63 .14
3 mo 5.80 ±1.03 16.80 ±4.52 <.001*
Pb
Regarding the EMG activity of the masseter, both Time <.001*
MAD and MOS participants had a significantly reduced Group×time interaction .04*
mean number of episodes per hour at 3 months Epi with noise

compared to baseline (Table 3). This finding is in Baseline 32.07 ±13.74 30.71 ±15.68 .81
1 mo 13.00 ±7.44 14.00 ±7.24 .72
agreement with the previous studies.10,15-17,31 The
3 mo 5.40 ±2.45 5.80 ±2.69 .61
mechanism behind the positive effect of the MAD may
Pb
be explained by the forward movement of the mandible,
Time <.001
which increases the airway space and reduces micro-
Group×time interaction .47
arousals, allowing deeper stages of sleep, as most
MAD, mandibular advancement device; MOS, maxillary occlusal splint.
bruxism episodes (80%) occur in the light-sleep stage.32 a
Unpaired t test.
However, further studies are needed to clarify this, as b
Repeated measures ANOVA.
*Statistically significant.
there are other hypotheses regarding the mecha-
nism.16,31,33 In contrast, the mechanism behind the MOS
is that it reduces the nocturnal massetric and temporalis
muscle activity by improving the muscular balance.34 long-term studies with a larger sample size may be ori-
Nevertheless, the variability of SB from night to night ented toward a smaller, less cumbersome MADs to reduce
might have modified the value of the SB oromotor- its adverse effects. These studies should also investigate
outcomes.35 To avoid this problem, the present study the effect of the MOS on SB.
recruited participants with intense and frequent SB. The limitations of the study include sample bias from
When we compared the MAD and MOS in regard to recruitment at a hospital-based tertiary care facility. A
the reduction of SB motor activity, we found that the community-based study consisting of a larger sample
participants with the MAD showed a greater reduction in size should be done to exclude bias. Participants may
episodes per hour, bursts per hour, and episodes with have had an emotional bias to favor the MOS as a result
noise compared to participants with the MOS (Table 3). of the discomfort associated with the MAD. Tooth
This was similar to the results reported by Landry et al,16 sensitivity associated with the MAD may also influence
who observed that the MAD can nearly double the oromotor activity. Furthermore, the study was performed
reduction of sleep -elated events compared to the MOS. over a short time span, with previous studies reporting
Although the MAD showed a greater reduction, it was that in some patients a reduction in SB motor activity can
associated with discomfort, including tooth sensitivity and persist up to 6 months.22
drooling, while it also was less esthetic than the MOS.
From the feedback form, most participants using the MOS CONCLUSIONS
were satisfied at the end of the study, and those using the The management of SB with either a MAD or MOS
MAD preferred to use a lighter and more comfortable improved participants’ sleep quality. Although the MAD
appliance if possible. These findings were in agreement provided a greater degree of improvement in the bruxism
with the previous studies.15,16 Certain studies have also indices, the MOS remains the SB treatment of choice, as its
reported some dentoskeletal modifications with the use of benefits outweigh its adverse effects in patients with SB.
a MAD.36,37 In our study, no such changes were observed,
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Corresponding author:
Dr Balendra Pratap Singh
New Teachers Apartment
Flat number 1, #10, TG Campus
Khadra, Lucknow
INDIA
Email: balendra02@yahoo.com
Copyright © 2015 by the Editorial Council for The Journal of Prosthetic Dentistry.
THE JOURNAL OF PROSTHETIC DENTISTRY