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Journal of Oral Rehabilitation

Journal of Oral Rehabilitation 2015 42; 862–874

Review
Management of sleep bruxism in adults: a qualitative
systematic literature review
DANIELE MANFREDINI*, JARI AHLBERG†, EPHRAIM WINOCUR‡ & FRANK
L O B B E Z O O § *Temporomandibular Disorders Clinic, Department of Maxillofacial Surgery, University of Padova, Padova, Italy,
† ‡
Department of Oral and Maxillofacial Diseases, University of Helsinki, Helsinki, Finland, Rehabilitation Department, School of Dental
Medicine, Tel Aviv University, Tel Aviv, Israel and §Department of Oral Kinesiology, Academic Centre for Dentistry Amsterdam (ACTA),
University of Amsterdam and VU University Amsterdam, MOVE Research Institute Amsterdam, Amsterdam, The Netherlands

SUMMARY This paper updates the bruxism decrease for devices providing large extent of
management review published by Lobbezoo et al. in mandibular advancement; (ii) all tested
2008 (J Oral Rehabil 2008; 35: 509–23). The review pharmacological approaches [i.e. botulinum toxin
focuses on the most recent literature on (two papers), clonazepam (one paper) and clonidine
management of sleep bruxism (SB) in adults, as (one paper)] may reduce SB with respect to placebo;
diagnosed with polysomnography (PSG) with (iii) the potential benefit of biofeedback (BF) and
audio–video (AV) recordings, or with any other cognitive–behavioural (CB) approaches to SB
approach measuring the sleep-time masticatory management is not fully supported (two papers);
muscles’ activity, viz., PSG without AV recordings and (iv) the only investigation providing an
or electromyography (EMG) recorded with portable electrical stimulus to the masseter muscle supports
devices. Fourteen (N = 14) papers were included in its effectiveness to reduce SB. It can be concluded
the review, of which 12 were randomised controlled that there is not enough evidence to define a
trials (RCTs) and 2 were uncontrolled before–after standard of reference approach for SB treatment,
studies. Structured reading of the included articles except for the use of OA. Future studies on the
showed a high variability of topics, designs and indications for SB treatment are recommended.
findings. On average, the risk of bias for RCTs was KEYWORDS: sleep bruxism, management, bruxism,
low-to-unclear, whilst the before–after studies had treatment, oral appliances, pharmacology,
several methodological limitations. The studies’ biofeedback, cognitive–behavioural therapy
results suggest that (i) almost every type of oral
appliance (OA) (seven papers) is somehow effective Accepted for publication 24 May 2015
to reduce SB activity, with a potentially higher

(indicated as sleep bruxism) or during wakefulness


Introduction
(indicated as awake bruxism)’ (1). Over the past few
Bruxism is an umbrella term grouping different motor years, as part of an ongoing strategy to summarise the
phenomena. Recently, an international expert group available findings on the argument, potential clinical
reached consensus to define it as follows: ‘bruxism is consequences of bruxism have been systematically
a repetitive jaw-muscle activity characterised by reviewed as far as its effects on the temporomandibu-
clenching or grinding of the teeth and/or by bracing lar joints and jaw muscles as well as on natural teeth
or thrusting of the mandible. Bruxism has two distinct and restored implant-supported dentitions are con-
circadian manifestations: it can occur during sleep cerned (2–4). On the other hand, evidence is gaining

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SLEEP BRUXISM MANAGEMENT 863

weight in support of the concept that a certain keyword term ‘bruxism’ was used to start browsing
amount of bruxism-related motor activities is not nec- the literature indexed in the two most qualified med-
essarily pathological (5, 6). ical databases (i.e. National Library of Medicine’s
Based on that, a need emerged to define the best Medline and Scopus) to retrieve lists of potentially
strategies to manage bruxism in the clinical setting. A relevant papers. The literature search was limited to
2008 review performed on the topic by Lobbezoo papers that were added to the databases later than
et al. (7) pointed out that most papers are inconclu- the date of Lobbezoo et al.’s search, viz., 28 June
sive due to the low methodological quality. Conse- 2007.
quently, along with a recommendation for designing Based on title and abstract assessment, the studies
higher-quality studies, the authors suggested that a were selected for potential inclusion independently by
common sense ‘triple-P’ approach, based on a combi- two of the authors (D.M, F.L.), who also performed
nation of oral appliances (i.e. ‘plates’), counselling/ data extraction and quality assessment, with any dis-
behavioural strategies (i.e. ‘pep talk’) and centrally agreements resolved by discussion to reach consensus.
acting drugs (i.e. ‘pills’), is the most suitable strategy All authors contributed to the search expansion by
to manage bruxism within the current evidence of a checking for potential additional papers in the Google
central aetiology of the condition (7). Scholar database, in the reference lists of relevant
Since that time, knowledge on bruxism has likely papers and in their own personal databases and insti-
been improved, especially as far as the aetiology and tutional libraries.
clinical relevance of the various bruxism-related The criteria for admittance in the systematic review
motor phenomena are concerned. In addition, other were based on the type of study, and the inclusion
literature reviews were performed on selected brux- was restricted to clinical investigations on humans,
ism management topics (8–11). Notwithstanding that, assessing the effectiveness of any treatment
findings still offer a fragmental picture and the need approaches to SB, as diagnosed with PSG or sleep-
for a state-of-the-art summary has emerged. time EMG of the masticatory muscles. Based on that,
Considering that, this paper aims to update the all clinical trials, cohort studies (i.e. before–after case
bruxism management review published by Lobbezoo series) or before–after case reports that fit with the
et al. in 2008 (7), by assessing the most recent litera- topic of SB management were included in the
ture on the topic. In an attempt to increase the review.
validity of our report, and given the absence of
widely accepted standards for an awake bruxism
Systematic assessment of papers
diagnosis, the review focuses on the management of
sleep bruxism (SB) in adults, as diagnosed with the The methodological characteristics of the selected
standard of reference approach, viz., polysomnogra- papers were summarised according to a format which
phy (PSG) with audio–video (AV) recordings, or with enabled a structured summary of the articles in rela-
any other approach measuring the sleep-time masti- tion to four main issues, viz., ‘P’ – patients/problem/
catory muscles’ activity, viz., PSG without AV record- population, ‘I’ – intervention, ‘C’ – comparison and
ings or electromyography (EMG) recorded with ‘O’ – outcome (PICO) (12).
portable devices. For each article, the study population (‘P’) was
described based on the criteria for inclusion, the
demographic features of the sample and the sample
Materials and methods
size. The intervention (‘I’) section included details of
the management approach under investigation, along
Search strategy
with information on the study design and the
On 15 March 2015, a systematic search in the medi- approach to SB diagnosis. The comparison criterion
cal literature was performed to identify all peer- (‘C’) was based on the description of the control con-
reviewed English language papers that were relevant dition(s) and features of the passive or active control
to the review’s topic, viz., sleep bruxism manage- group(s). The study outcome (‘O’) was evaluated in
ment in adults. With the aim to be as inclusive as relation to a brief summary of the main study’s
possible, as a first step in the search strategy, the findings.

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864 D . M A N F R E D I N I et al.

Quality assessment of randomised controlled trials (RCTs) only does the intervention differ between groups,
the method of delivering it also differs.
The methodological quality and risk of bias of
4 Blinding of outcomes assessment: graded as yes
included RCTs were assessed in accordance with the
(A), unclear (B) no (C). It refers to whether per-
Cochrane Handbook (13) and the guidelines of the
sons assessing the outcome of care were aware of
Cochrane Handbook of Systematic Reviews of Interventions
which treatment the participant received. Such
426 (14).
detection bias can be minimised when the outcome
The guidelines recommend the explicit reporting of
assessor is blind to participant groups. A lack of
the following individual elements for RCTs: random
blinding can exaggerate the estimated effect of
sequence generation and allocation sequence conceal-
treatment.
ment (selection bias); blinding of participants and per-
5 Handling of withdrawals and losses (i.e. complete-
sonnel (performance bias); blinding of outcome
ness of outcome data): graded as yes (A), unclear
assessment (detection bias); completeness of outcome
(B) or no (C). It is judged based on the presence of
data (attrition bias); selective outcome reporting
a clear description of the difference between the
(reporting bias); and other sources of bias. Each item
two treatment groups of losses to follow-up.
was judged as being at low (A), unclear (B) or high
6 Outcome reporting: graded as adequate (A), unclear
(C) risk of bias, based on the specifications provided
(B) or inadequate (C). It is possible that only some
below:
outcomes are included in the trial report (i.e. selec-
1 Randomisation: graded as adequate (A), unclear tive reporting), meaning that some of the outcomes
(B) or inadequate (C). Adequate (A) included any have been omitted from the report and thus lead-
one of the following methods of randomisation: ing to an inadequate outcome reporting.
computer generated or table of random numbers, 7 Other risk of bias: graded as yes (A), unclear (B) or
drawing of lots, coin-toss, shuffling cards or throw no (C). This evaluation focused on the presence of
of a dice. Inadequate method of randomisation (C) any other methodological shortcomings related
utilising any of the following: case record number, with the study design or SB evaluation that may
date of birth or alternate numbers were judged as have influenced the study results.
inadequate (quasirandomised studies).
2 Concealment of allocation: graded as adequate (A),
Quality assessment of uncontrolled cohort before–after
unclear (B) or inadequate (C). Allocation conceal-
studies and case series
ment means that the process of allocating partici-
pants or actually placing them to the different The methodological quality of the included cohort
groups to which they have been randomly assigned before–after studies was assessed adopting the Critical
must be concealed from the person recruiting par- Appraisal Skills Programme (CASP) Cohort Study
ticipants into the trial. Adequate (A) methods of Checklist (15). The CASP tool uses a systematic
allocation concealment would include either central approach based on 12 specific questions to appraise
randomisation or sequentially numbered sealed three broad areas: an assessment of study validity, an
opaque envelopes. This criterion was considered evaluation of methodological quality and presentation
inadequate (C) if there was an open allocation of results, and an assessment of external validity. The
sequence and the participants and trialists could twelve items were stated as follows:
foresee the upcoming assignment.
1 Study issue is clearly focused
3 Blinding of participants and personnel: graded as
2 Cohort (or cases) is recruited in an acceptable way
yes (A), unclear (B) or no (C). This bias arises from
3 Exposure (SB) is measured accurately
systematic differences in the way that care is pro-
4 Outcome (post-treatment changes in SB variables)
vided or from exposure to factors other than the
is measured accurately
intervention that is being studied. Such perfor-
5 Confounding factors are addressed
mance bias occurs during the treatment and/or
6 Follow-up is long and complete
delivery of the intervention(s). It arises as the result
7 Results are clear
of differences in the way that the intervention is
8 Results are precise
delivered to the different study groups; that is, not

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SLEEP BRUXISM MANAGEMENT 865

9 Results are ‘credible’ sion of occlusion (VDO) (39) and the appliance design
10 Results can be applied to the local population (34, 38) are concerned. These papers account for 121
11 Results fit with available evidence participants in total, with non-homogeneous recruit-
12 There are important clinical implications ment strategies as far as the SB severity and the
demographic features are concerned. Follow-up dura-
Each of the questions can be answered with ‘yes’,
tion also varies across studies, ranging from the very
‘no’ or ‘can’t tell’. ‘Yes’ answers are endorsed one
few protocol days (i.e. 3–5) in a short-term crossover
point, so that each study can have a maximum score
investigation (38) to up to 3 months in the uncon-
of 12.
trolled before–after study (40). Similarly, the observa-
tion points are multiple, viz., more than only the
Results
baseline and end-of-treatment assessments, in a few
studies only (29, 33, 39). Findings with respect to the
Literature search outflow
effects of treatment protocols on SB parameters are
The search allowed identifying 878 and 1470 citations variable and hard to interpret. The investigations
in the Medline and Scopus databases, respectively, of comparing different OA designs and treatment regi-
which 854 were present in both databases. Thus, mens suggest that stabilisation splints are better than
1494 citations were screened for eligibility. As shown palatal splints (33); an intermittent use is superior to
in Fig. 1, after excluding the citations that were continuous wearing (29); a 3 mm increase in VDO is
clearly not pertinent for the review’s aim on the basis more effective than a 6 mm increase (39); a mandibu-
of their title and abstract (TiAb screening), 26 papers lar advancement appliance (MAA) with a robust
were retrieved in full text and were assessed to reach advancement (75%) is superior to less marked (25%)
consensus as to include/exclude the papers for/from advancement devices (38); and the restriction of man-
systematic assessment. Consensus decision was to dibular movements with oral appliances does not
exclude 12 of the 26 papers. Reasons for exclusion have any major influence on jaw-muscle activity dur-
were the following: single case reports of patients ing sleep (34). Stabilisation appliances are equally
treated for bruxism not diagnosed with PSG or EMG effective as the neuroleptic drug gabapentin, which is
(N = 4) (16–19); case series of cohorts of patients trea- only slightly superior to reduce SB events in subjects
ted for bruxism not diagnosed with PSG or EMG with poor sleep quality (32). The before–after study
(N = 4) (20–23); studies with an absence of criteria concludes that a MAA providing a 50–75% advance-
that were used for scoring SB activity (N = 3) (24– ment significantly decreases the number of SB epi-
26); and a survey paper (N = 1) (27). Thus, fourteen sodes (40).
papers were included in the review. Of them, twelve Four papers report on pharmacological manage-
were RCTs (28–39) and two were uncontrolled ment of SB. Two of them deal with botulinum toxin
before–after studies (40, 41). injections of the jaw muscles, either in a controlled
Search expansion strategies did not allow retrieving (36) or in an uncontrolled setting (31). Two other
any other relevant papers, and 14 papers entered the papers had a crossover design, assessing the effective-
review process. ness of clonazepam (37) or clonidine (35) with
respect to placebo. In total, 90 subjects took part in
those studies. In general, the findings from botulinum
Structured reading of papers and report of main findings
toxin studies are supportive of its effectiveness to
Structured reading of the included articles showed a reduce the intensity of SB episodes, but not their fre-
high variability of topics and designs (Tables 1–2). quency (31). Follow-up assessments are provided for
Seven papers report on the effectiveness of oral up to 12 weeks, thus not allowing to draw conclu-
appliances (OA), either with a before–after (40) or sions on the duration of those effects. The two pla-
with a RCT design (29, 32–34, 38, 39). The latter cebo-controlled crossover studies have an observation
includes comparison groups treated with gabapentin period limited to the three nights of the protocol
(32), with palatal appliances (33), or adopting differ- regime and suggest that both the benzodiazepine clo-
ent protocols as far as the intermittent vs continuous nazepam and the antihypertension drug clonidine
appliance wearing (29), the different vertical dimen- may have SB-reducing effects (35, 37).

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866 D . M A N F R E D I N I et al.

Fig. 1. Flow chart of search strategy.


See text and tables for footnotes.

Two papers deal with sleep hygiene and relaxation related with the unclear report of the strategies that
techniques, as compared to untreated subjects (28) were adopted to blind outcome evaluations (916%)
and with the effects of wake-time EMG biofeedback as well as with the unclear report of randomisation
on SB parameters (30). The total number of partici- procedures and allocation concealment (666%).
pants amounted to 29 individuals, with very different Other potential risks of bias are related with the
age ranges. The studies have similar duration (3– EMG-only SB diagnosis that was adopted in 416% of
4 weeks) and have two and three observation points, studies, the measurement of one-night effect only
respectively. None of them followed up patients after (25%) and the failure to include multiple (i.e. more
the end of treatment. Findings suggest that a wake- than two) observation points (25%). The impact of
time EMG-based biofeedback program aiming to such sources of risk has been judged as ‘unclear’.
reduce awake bruxism may also reduce SB events Quality assessment of the two before–after studies
(30). A protocol comprising teaching of sleep hygiene shows several methodological limitations, mainly due
measures as well as muscle relation techniques is not to the adoption of very small-sized convenience study
effective to reduce SB (28). samples and the failure to include multiple observa-
The remaining paper reports an uncontrolled series tion points.
of ten patients receiving electrical stimuli to the mas-
seter muscles (41). The protocol provided a three-
Discussion
night EMG recording under three conditions, viz.,
one without electrical stimuli vs two nights with stim- Bruxism is a phenomenon of growing interest for
uli provided at two different sensation thresholds many specialists. Based on the need for providing evi-
immediately after the heart rate exceeded 110%. dence-based knowledge, a series of systematic litera-
Findings are suggestive of the effectiveness of such ture reviews on various bruxism topics has recently
electrical stimuli to suppress SB. been published (1–4, 42, 43). Notwithstanding that, it
seems that information on the management of brux-
ism is still fragmental, as suggested by the common
Quality assessment
sense suggestions recommended by Lobbezoo et al. (7)
Quality assessment of RCTs shows that, on average, in a paper summarising the principles for the manage-
the risk of bias was low-to-unclear for all the ment of bruxism. The present review focused on the
reviewed studies (Tables 3–4). Risks of bias are mainly recent literature on SB management, viz., published

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874 D . M A N F R E D I N I et al.

27. Ommerborn MA, Taghavi J, Singh P, Handschel J, Depprich appliance on sleep bruxism: a crossover sleep laboratory
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868 D . M A N F R E D I N I et al.

Table 1. (continued)

Study first
author, year Population (P) Intervention (I) Comparison (C) Outcomes (O)

Madani, 2013 N = 24 patients (11M, Group A (m.a. Group B (m.a. Significant reduction in
(32) 13F, m.a. 317  92 years): hard SS 261  52 years): most SB variables in
283  71 years, range covering the maxillary gabapentin – 1 both groups after
18–50) with complaint of dental arch 2-month capsule (100 mg) treatment
SB (ICSD criteria) protocol PSG Two orally at bedtime
observation points for the first 3
(baseline and 2 months) nights, then
200 mg/night for
the next 3 nights,
thereafter
300 mg/night
continued for
2 months
Takahashi, N = 23 (11M,12F; m.a. Test group: SS covering the Control group: PS The number of MMA
2013 (33) 222 years) healthy occlusal surfaces of the not covering the events per hour
volunteers maxillary dental arch maxillary teeth decreases significantly
Crossover design with two with SS
weeks washout between
phases One-channel EMG
Three 3-day observation
points
Arima, 2012 N = 11 subjects Test group: restrict-MMOA Control group: The total number of
(34) (4M, 263  32 years; that prevented from free-MMOA that phasic EMG episodes and
7F, 259  31 years) performing mandibular allowed normal bursts per hour of sleep
with self-reported SB movements 30-night mandibular is significantly reduced
protocol Crossover design movements; during any of the three
with one of the three or free-MOA combinations of oral
types of appliances Bilateral masseter appliances when
(1 week each) Bilateral EMG compared with baseline
masseter home-EMG Six values The restriction of
observation points (nights mandibular movements
1, 2, 3, 16, 23 and 30) with oral appliances does
not have any major
influence on jaw-muscle
activity during sleep
Carra, 2010 N = 16 SB subjects (6M, Test group: single dose of Control group: RMMA/SB decreases
(35) 10F; m.a. 245 years; clonidine (03 mg by single dose of under clonidine
range 21–31) mouth) 1 h before placebo
bedtime 4-night protocol
PSG Crossover design
Lee, 2010 (36) N = 12 subjects (7M, m.a. Test group (3M,3F; Control group The injection of
25  23 years; 5F, m.a. 250  22 years): BTX-A (4M,2F; botulinum toxin in the
248  08 years) with into each subject’s 248  14 years): masseter muscle reduces
nocturnal bruxism masseter muscles at three saline injection the number of bruxism
(unspecified criteria) sites – 80U of BTX-A into each subjects’ events during sleep for
12-week observation masseter muscles up to 12 weeks
EMG of both masseter and at three sites –
temporalis muscles for 08 ml of saline
three consecutive nights at
home for an average of
6 hrs per night
Four observation points
(baseline, 4, 8, 12 weeks)

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SLEEP BRUXISM MANAGEMENT 869

Table 1. (continued)

Study first
author, year Population (P) Intervention (I) Comparison (C) Outcomes (O)

Saletu, 2010 N = 21 drug-free Test group: crossover study, Control group: 21 The bruxism index is
(37) middle-aged patients with three consecutive sex and age- significantly improved
(10M,11F; m.a. (pre-drug night, placebo matched subjects under 1 mg clonazepam
451  126 years) with night and clonazepam - without SB (41% improvement with
SB (ICSD criteria) 1 mg night) Non-randomised respect to placebo on
PSG study individual change
Three observation points values)
Landry, 2009 N = 12 moderate to Test group: MAA (25% or Control group: MAA are more effective
(38) severe SB (3M,9F; m.a. 75% advancement) MOS than MOS to reduce SB
26  15 years) 5-night crossover The short-term use of a
PSG robust MAA (75%) is
Three observation points associated with SB
(nights 3 to 5) decrease
Abekura, 2008 N = 12 healthy volunteers Test group: Occlusal splints Comparison group: Splint with 3 mm increase
(39) (4M, m.a. 253 years) at 3 mm VDO increase Occlusal splints at in VDO is superior to
worn for two nights 6 mm VDO 6 mm-splint in
Crossover design with increase worn for decreasing bruxism
more than 6 nights two nights
washout between phases
One-sided masseter and
temporalis muscle EMG
Three observation points

M, males; F, females; m.a., mean age; a.r., age range; TG, tooth grinding; SA, stabilisation appliance; AB, awake bruxism; BF, biofeed-
back; BTX-A, botulinum toxin-A; U, unit; RMMA, rhythmic masticatory muscle activity; ANOVA, analysis of variance; ICSD, Interna-
tional Classification of Sleep Disorders; SS, stabilisation splint; PS, palatal splint; MMA, masticatory muscle activity; MMOA, maxillary
and mandibular oral appliance; MOA, maxillary oral appliance; MAA, mandibular advancement appliance; MOS, mandibular occlusal
splint; VDO, vertical dimension of occlusion.

later than Lobbezoo et al.’s review, providing both a Quality assessment of the reviewed RCTs shows the
qualitative assessment and a structured overview of methodology is generally acceptable, even if some
included papers. areas with potential risk of bias seem to be common
Findings suggest that the number of recent papers to several investigations. In particular, strategies for
on the argument that adopted an objective SB evalua- randomisation and allocation concealment are unclear
tion (i.e. measurement of actual masticatory muscle in two-thirds of the studies. In addition, the adoption
activity by means of PSG or EMG), even if higher of only two observation points (i.e. baseline and end-
than that in Lobbezoo et al.’s review (7), is still scarce. of-treatment assessments) as well as the single-chan-
Such finding is in line with other reviews on selected nel masseter recordings without full audio–video PSG
bruxism management topics (8–11). In an attempt to evaluation are other factors that may have influenced
be as comprehensive as possible, inclusion in the results of several papers. As for the before–after stud-
review was tentatively open also to before–after case ies, they are very small-sized and include only two
series and case reports, in addition to RCTs. Notwith- observation points, thus having potential limitations
standing that, we retrieved only twelve RCTs and two in terms of their external validity. However, the
uncontrolled before–after studies (i.e. case series) that choice to include only papers in the review with a
were eligible for inclusion. The included papers cover definite sleep bruxism diagnosis (i.e. PSG) or its best
a wide variety of management strategies, and the lack available alternative (i.e. sleep-time EMG adopting
of between-study homogeneity as far as the study criteria for SB activity) has likely resulted in an
design is concerned prevented us from performing acceptable internal validity of the reviewed investiga-
any meta-analysis of data. tions (1).

© 2015 John Wiley & Sons Ltd


870 D . M A N F R E D I N I et al.

Table 2. Features of the reviewed


Study first Comparison Outcomes
studies based on PICO-like struc-
author, year Population (P) Intervention (I) (C) (O)
tured reading. Before–after studies
Mainieri, 19 subjects MAD for 3 months; No control 337%
2014 (40) (9M,11F; m.a. 50–75% group reduction in
399  129 years) advancement EMG episodes
with clinical SB per hour
Sumiya, 10 subjects (6M,4F; BF (masseter EMG No control Electrical
2014 (41) m.a. 267  35 years) stimulation after group stimulation
with SB awareness heart rate increase) can reduce
the number
of SB events

MAD, mandibular advancement device; BF, biofeedback.

As for the results, it seems that all tested pharmaco- the relative safety and non-harmful nature of such
logical approaches [i.e. botulinum toxin (two papers) approaches, it seems prudent to recommend their
(31, 36), clonazepam (one paper) (37) and clonidine inclusion in any SB treatment protocol to maximise
(one paper) (35)] may reduce SB with respect to pla- the effects of any multimodal approach, even if not
cebo. Botulinum toxin’s effects are not surprising, and effective as stand-alone therapies.
they are in line with the expected pharmacological Studies on the effectiveness of OA provide interest-
properties of the drug. However, the fact that both ing findings as well. Despite the variability in their
studies on the argument show a reduced intensity, study design, some general remarks can be suggested
but not frequency, of SB episodes suggests that on the topic. First, it seems that almost every type of
peripherally acting drugs do not affect the genesis of OA is somehow effective to reduce SB activity. This
SB episodes (31, 36). Such findings are in line with may suggest the existence of a potential ‘novelty-
clinical investigations showing that improvement in effect’ associated with the use of an OA, which leads
muscle pain levels after botulinum toxin injection is to a reduction in sleep-time masticatory muscles’
not unequivocally superior to placebo (44, 45) or to activity, possibly due to the transient need for reor-
physiotherapy (46). On the other hand, centrally act- ganising motor unit recruitment. This hypothesis may
ing drugs, such as the benzodiazepine clonazepam find support in the observation that intermittent OA
(37) and the antihypertension clonidine (35), are both use is more effective to reduce SB than continued use
effective in reducing SB frequency. The effects of clo- (29). However, the actual existence, clinical meaning
nazepam, which has sedative and muscle relaxant and duration of this effect should be assessed in
properties, were to a certain extent predictable, whilst future studies with longer follow-up time spans. Sec-
the actual action mechanism of clonidine is yet to be ond, it seems that OA that are designed to provide a
clarified. One hypothesis is that, as clonidine is a high extent of mandible advancement (50–75%) are
selective a2-agonist with sympatholytic effect and effective to reduce SB (38, 40). Such findings may be
activation of the sympathetic autonomic nervous sys- explained with the reduced contractile properties of
tem precedes bruxism events, such medication proba- masseter muscles when the mandible is advanced
bly interrupts the cascade of events that result in (48) and/or with the elimination of the amount of
bruxism episodes (35, 47). SB-like motor phenomena that are actually part of an
On the other hand, the two papers on the potential apnoea-induced arousal (5). The former hypothesis
benefit of biofeedback (BF) and cognitive–behavioural contrasts with the reported lower effectiveness of OA
(CB) approaches to SB management are not support- with a markedly increased VDO (i.e. 6 mm) with
ive of their effectiveness (28, 30). Such findings are in respect to 3 mm-thick OA (39), as an increase in
contrast with early reports of positive effects associ- VDO is actually expected to reduce the contractile
ated with several BF and CB approaches, which led capability and efficiency of jaw-closing muscles (48).
Lobbezoo et al. (7) to include ‘pep talk’ (i.e. counsel- Thus, the potential mechanisms of action through
ling strategies) as part of a common sense approach to which OA may reduce SB are yet to be explored in
bruxism management. Notwithstanding that, given detail.

© 2015 John Wiley & Sons Ltd


Table 3. Quality assessment of RCTs based on the Cochrane Handbook of Systematic Reviews of Interventions. Reasons for risk of bias are provided

Risk of Risk of Risk of


Risk of selection performance detection Risk of reporting
bias: random Risk of selection bias: blinding bias: blinding attrition bias: bias:
Study first sequence bias: allocation of personnel of outcome incomplete selective
author, year generation concealment and participants assessment outcome data reporting Risk of other bias

Valiente, 2015 (28) Unclear Unclear Low Low Low Low Unclear (only two
observation points)

© 2015 John Wiley & Sons Ltd


Matsumoto, 2015 (29) Low Low Unclear Unclear Low Low Unclear (no PSG – only
EMG diagnosis)
Sato, 2015 (30) Unclear Unclear Unclear Unclear Low Low Low
Shim, 2014 (31) Unclear Unclear Unclear Unclear Low Low Unclear (only two
observation points)
Madani, 2013 (32) Unclear Unclear Unclear Unclear Low Low Unclear (only two
observation points)
Takahashi, 2013 (33) Low Low High (crossover Unclear Low Low Unclear (no PSG –
design with only EMG diagnosis)
different appliance
design)
Arima, 2012 (34) Unclear Unclear High (crossover Unclear Low Low Unclear (no PSG –
design with only EMG diagnosis)
different appliance
design)
Carra, 2010 (35) Unclear Unclear Unclear Unclear Low Low Unclear (only
one-night effect)
Lee, 2010 (36) Unclear Unclear Unclear Unclear Low Low Unclear (no PSG –
only EMG diagnosis)
Saletu, 2010 (37) High (controlled High (controlled Low Unclear Low Low Unclear (only
case–control case–control one-night effect)
design) design)
Landry, 2009 (38) Low Low High (crossover Unclear Low Low Unclear (only
design with one-night effect)
different appliance
design)
Abekura, 2008 (39) Unclear Unclear High (crossover Unclear Low Low Unclear (no PSG –
design with only EMG diagnosis)
different appliance
design)
SLEEP BRUXISM MANAGEMENT
871
872 D . M A N F R E D I N I et al.

quality

(0–12)
Finally, the only investigation providing an electri-
Table 4. CASP quality assessment of the reviewed papers. Before–after studies. Columns show the twelve quality items (see text for explanations). Reasons for negative end-

score
Total
cal stimulus to the masseter muscle to suppress its

5
sleep-time activity supports the effectiveness of such

implications)

implications)
No (unclear

No (unclear
kind of stimulation to reduce SB (41). This finding is

Item #12
in line with papers adopting different protocols of
contingent electrical stimulation (CES) of the tempo-
ralis muscle, either with a RCT (24, 25) or a before–

(other studies
not available)
after design (26), which were not included in this
review due to the lack of adoption of criteria that

Can’t tell
Item #11

were used for scoring SB activity.


In general, findings from the reviewed literature
Yes

suggest that evidence-based recommendations on SB


Item
#10

Yes

Yes

management at the individual level are not yet


available. In particular, it must be remarked that
Item

Yes

Yes

none of the reviewed papers focused on the indica-


#9

tions for treatment. Such an approach contrasts with


Item

Yes

Yes

recent recommendations to consider SB as a phe-


#8

nomenon, and not a disorder per se (1, 4). Motor


Item #7

activities grouped under the umbrella term ‘bruxism’


Yes

Yes

do not necessarily have a pathological relevance and


are not necessarily treatment-demanding conditions
No (only two

No (only two
observation

observation

(49). This means that overtreatment of unspecific


points)

points)
Item #6

SB phenomena may be a concern until the relation-


ship with clinical symptoms and consequences is
fully clarified for each motor activity. Until now, an
of other bruxism-
No (no evaluation

approach aiming to manage SB as a whole via the


other bruxism-
related issues)

related issues)
evaluation of

reduction of muscle activity did not lead to clear


conclusions as far as the reduction in clinical pain
Item #5

No (no

levels are concerned (26, 44, 45).


Thus, from a clinical viewpoint, it is important that
the investigations on SB management focus on the
No (only
Item #4

EMG)

motor activities that are associated with clinical conse-


Yes

quences, also targeting symptoms as a treatment goal.


The study of the triangle bruxism – pain – psychoso-
No (only
Item #3

EMG)

cial factors may contribute considerably to understand


which SB phenomena should be viewed as treatment-
Yes

demanding conditions. Based on that, it must be


strategy and very
low sample size)

pointed out that current evidence does not support


the existence of a standard of reference protocol for
recruitment

strategy and

sample size)
recruitment
No (unclear

No (unclear

very low

SB treatment. Thus, it is still recommendable that SB


Item #2

management is provided with caution within the


framework of a conservative, ‘multiple-P’ approach
(i.e. plates, pep talk, pills, psychology, physiotherapy).
orsement are provided

Item #1

Yes

Yes

Conclusions
author, year

2014 (40)

2014 (41)
Study first

Mainieri,

The present literature review on SB management pro-


Sumiya,

vides an update with respect to the last paper on the


argument (i.e. the 2008 review by Lobbezoo et al.) (7)

© 2015 John Wiley & Sons Ltd


SLEEP BRUXISM MANAGEMENT 873

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