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Assessing the effectiveness of botulinum toxin injections into masticatory muscles in the treatment of temporomandibular disorders

Authors:
  • Clinique Saint Joseph Trélaze, France

Abstract and Figures

Introduction: Temporomandibular disorders (TMD) are a common and invalidating disease sometimes difficult to treat. Current international recommendations favour reversible and non-invasive treatments, including the injection of botulinum toxin (BTX) into masticatory muscles. There is no strong evidence of its effectiveness. Objective: The main goal of this study was to assess the effectiveness of BTX six months following injection, in terms of pain, mouth opening, improvement of symptoms and duration of effect. Materials and methods: A retrospective study carried out at Nantes University Hospital between 2014 and 2016. Results: Thirty-four patients were included. The mean age was 37 years (17-76) and seventy six percents were female. Eighty percent of patients reported a significant improvement, notably in cases of arthralgia, which decreased in 8/18 (44%) patients (p < 0.05). The mean duration of measured efficacy was 4.2 months. Discussion: Significant improvement in cases of arthralgia and a tendency for improvement in cases of myalgia, with a mean duration of action of 4.2 months. Although BTX injection do not guarantee complete resolution of myofascial pain, it have been shown to have beneficial effects on some symptoms have been shown. Conclusion: Botulinum toxin should be considered as an alternative treatment when other conservative methods fail to yield satisfactory results. A thorough multicentre assessment is necessary in the future to scientifically validate its use.
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Original Article
Assessing the effectiveness of botulinum toxin injections
into masticatory muscles in the treatment
of temporomandibular disorders
Alexis Kahn
1,2,*
, Helios Bertin
2
, Pierre Corre
2
, Morgan Praud
2
, Arnaud Paré
3
,
Jean-Daniel Kün-Darbois
1
1
Department of Maxillofacial Surgery and Stomatology, Angers University Hospital, Angers, France
2
Departement of Maxillofacial Surgery and Stomatology, Nantes University Hospital, Nantes, France
3
Department of Maxillofacial and Facial Plastic Surgery, Tours University Hospital, Tours, France
(Received: 7 December 2017, accepted: 10 January 2018)
Keywords:
temporomandibular
disorder / botulinum
toxin injection /
effectiveness
Abstract -- Introduction: Temporomandibular disorders (TMD) are a common and invalidating disease sometimes
difcult to treat. Current international recommendations favour reversible and non-invasive treatments, including
the injection of botulinum toxin (BTX) into masticatory muscles. There is no strong evidence of its effectiveness.
Objective: The main goal of this study was to assess theeffectiveness of BTX six months following injection, in terms
of pain, mouth opening, improvement of symptoms and duration of effect. Materials and methods: A retrospective
study carried out at Nantes University Hospital between 2014 and 2016. Results: Thirty-four patients were included.
The mean age was 37 years (1776) and seventy six percents were female. Eighty percent of patients reported a
signicant improvement, notably in cases of arthralgia, which decreased in 8/18 (44%) patients (p<0.05). The
mean duration of measured efcacy was 4.2 months. Discussion: Signicant improvement in cases of arthralgia and a
tendency for improvement in cases of myalgia, with a mean duration of actionof 4.2 months. Although BTX injection
do not guarantee complete resolution of myofascial pain, it have been shown to have benecial effects on some
symptoms have been shown. Conclusion: Botulinum toxin should be considered as an alternative treatment when
other conservative methods fail to yield satisfactory results. A thorough multicentre assessment is necessary in the
future to scientically validate its use.
Introduction
Temporomandibular disorders (TMD) are, after dental pain,
the most common cause of orofacial pain. It may affect
approximately 7080% of the adult population between the
age of 20 and 45, which makes it a public health concern [1]. A
TMD is dened as a dysfunctional mandibular disorder resulting
from myoarthropathy of the masticatory system. There are 2
types: articular and muscular, sometimes combined.
The diagnosis of TMDs is mainly clinical, with at least one of
the three cardinal signs, represented in the acronym BADin
french [2]:
Bfor Bruit : noise in the temporomandibular joints (TMJ)
during jaw movements (clicking, popping and crepitus).
Afor Algie : facial pain modulated by jaw function.
Dfor Dyskinesia, or abnormal jaw movements (restriction
or shifting).
International cohort studies have shown that pain caused
by TMDs affects between 11.3% and 12.7% of women, and 6.5%
of men [3,4].
The pain is recurrent in 65% of cases and persistent in 19%
of cases. Arthralgia occurs together with myalgia in 73% of
cases, while in 23% of cases the patient suffers from myalgia
alone [4].
The treatment of TMD has signicantly changed in recent
years. Current international recommendations [5,6] propose
resorting to reversible, non-invasive procedures rst. The
purpose is to reduce the impact of pain and associated
functional limitations.
To this end, the various therapies are:
patient information and education like suppression of
parafunctions such as onychophagy, chewing gum etc;
cognitive-behavioural therapy for stress patients;
*Correspondence: alexis.kahn@chu-angers.fr
J Oral Med Oral Surg 2018;24:107-111
©The authors, 2018
https://doi.org/10.1051/mbcb/2018001
https://www.jomos.org
This is an Open Access article distributed under the terms ofthe Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits
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107
physical methods such as physiotherapy and kinesiotherapy
(massages, transcutaneous electrical nerve stimulation, ...);
pharmacotherapy to relieve pain and inammation (analge-
sics, nonsteroidal anti-inammatory drugs, myorelaxants,
);
arthrocentesis or joint aspiration;
occlusal orthopedic devices to stabilise the joints, protect
the teeth, redistribute occlusal forces, relax masticatory
muscles, and treat bruxism.
The French Association for Stomatology, Oral and Maxillo-
facial Surgery (Société Française de Stomatologie, Chirurgie
Maxillo-Faciale et Chirurgie Orale, SFSCMFCO) includes this
strategy in its good practice recommendations [7].
If usual therapeutic interventions fail, patients may be
offered a botulinum toxin injection into their masticatory
muscles.
Botulinum toxin (BTX) is a bacterial metalloproteinase
produced by Clostridium botulinum. This neurotoxin specically
blocks the release of acetylcholine in the presynaptic membrane
of neuromuscular junctions [8]. BTXA is injected into masticatory
muscles (masseter and temporalis) to treat trismus, bruxism,
masticatory muscle myalgia, temporomandibular joint disorders
or muscle hypertrophy [9] with a Ib evidence level [10]. The rst
studies on temporomandibular dysfunction (TMD) were con-
ducted by Freund et al. in 1998 and 1999 [11,12].
There is currently no formal proof of its efcacy with the
indications mentioned above. In fact, many monocentric
studies have shown signicant efcacy [11,1316], but a
recent review paper [17] based on randomised, placebo-
controlled trials concluded that there was no consensus
regarding the therapeutic advantages of BTX for TMDs.
The purpose of this study was to assess the global efcacy
of botulinum toxin injections into masticatory muscles for
patients with TMDs whose treatment had failed. Unlike other
monocentric studies, this study aimed at evaluating also the
BTX effect on the specic TMD symptoms that impair the quality
of life such as mouth opening, myalgia, arthalgia, and
headache.
Materials and methods
Data collection
We conducted a retrospective study involving every patient
who had received at least one injection of botulinum toxin into
masticatory muscles was conducted and whose treatment was
carried out at the Stomatology and Maxillofacial Surgery
department of the Nantes University Hospital between 2014
and 2016. Patients who were enrolled in the study had been
suffering from TMD for more than six months. BTX was used
after failure of non-invasive therapies. Patients were informed
of the use of their medical records. The study obtained the
approval of the regional Ethics Committee (no. 2016/41).
All patients answered a series of questions about the
history of their disease. The NFDcriteria were assessed during
the clinical examination: myalgia and its location, joint pain
and noises, mouth opening range and kinetics.
BTX injection protocol
The main four masticatory muscles, the two masseters and
the two temporalis muscles, were regularly injected, regardless
of whether the symptoms were unilateral or bilateral. These
injections were performed by experienced specialists who were
familiar with the anatomical identication technique.
The injection was performed using a 1 mL insulin syringe
and a 26G needle, at a dilution of 10 U/mL physiological
injectable saline.
A total dose of 100 U was injected with 100 mL at 10 sites: 3
sites per masseter and 2 per temporalis muscles (Fig. 1). The
dose was increased to 150U in the event of insufcient
response after many injections, or reduced to 50 U for patients
who experienced pain relief.
After removing the anaesthetic lidocaine hydrochloride
cream patches (applied 1 h earlier in the masseter area) and
disinfecting the skin, the masseter muscle was rst injected
1 cm in front of and above the gonial angle, which usually
corresponds to the trigger point. The other two injection sites
Fig. 1. Injection sites of the botulinum toxin, 3 sites per masseter and
2 per temporalis muscles.
J Oral Med Oral Surg 2018;24:107-111 A. Kahn et al.
108
were 1 cm in front of and 1 cm above the rst site of injection.
After that, the temporalis muscle was injected 1 cm behind the
hairline to avoid frontalis muscle paresis, preferably in the
painful area, followed by 1 cm behind it. If possible, injections
were preferably applied at the trigger points.
Clinical evaluation
An intraoral examination was perform to assess the dental
occlusion and teeth and periodontal damage caused by bruxism
or parafunction. The existence of dentoskeletal dysmorphosis
was also evaluated. The initial and follow-up reports identied
3 main TMD symptoms: joint pain, myalgia and headache/
cervicalgia.
A clinical evaluation of efcacy and tolerance was
performed at 3 and 6 months after the injection. Patients
were re-examined to assess the mouth opening, the symptom
release, and the BTX effect duration.
The primary endpoint was patient satisfaction, based on
the improvement of the initial symptoms (myalgia, arthralgia,
and headache).
The secondary endpoints were based on a comparison of
mouth opening, progression of TMD symptoms (myalgia,
arthralgia, and headache/cervicalgia), and the average
duration of the BTX effect.
Statistical analysis
A Wilcoxon test was performed to evaluate differences
between mouth openings. Data relating to symptom improve-
ment before and after the BTX injection were compared using a
Chi-square test.
The analyses were performed using Excel (Microsoft) and
Systat 13 software.
For every comparison, the null hypothesis was a lack of
difference between the measurements made before and after the
BTX injection. Statistical signicance was dened as p<0.05.
Results
Epidemiological data
Our study included 40 patients. Among them, 34 answered
all the questions. Six patients were not followed up. The group
was made up of 76.5% of women (n= 26) with a mean age of 37
(1776) at the rst injection (Tab. I). The male/female ratio
was 3 females for every male.
Among the identied TMD risk factors, 53% (n= 18) had a
class II deformity. Among them, 17.6% (n= 6) were class II.2.
Bruxism was identied in 26.5% (n= 9) of patients.
Regarding TMD symptoms, 19 (56%) patients were suffering
from myalgia, 18 (53%) from arthralgia and 13 (38%) from
headached or cervicalgia. Five patients were followed in a pain
treatment centre.
Masticatory muscle hypertrophy was observed in 26.5%
(n= 9) of patients.
As part of treatment before the BTX injections, 76.5% of
patients (n= 26) used occlusal splint to prevent bruxism,
57.7% (n= 15) did not report sufcient pain relief.
Ninety injection sessions were performed on the whole
population. Fifty percent of patients (n= 17) received only one
injection, 14.7% (n= 5) received two, and the average was 2.6
injections per patient (Tab. II).
Functional results
Subjective clinical improvement was observed in 80% of
patients. Regarding TMD symptoms, myalgia decreased in 8/19
(42%) patients (p= 0.0507), Arthralgia decreased in 8/18
(44%) patients (p= 0.0487), and headaches or cervicalgia
decreased in 3/13 (23%) patients (p>0.05). the average
mouth opening was 34 mm before and 36 mm after the injection
(p= 0.15) (Tab. III). The mean duration of measured efcacy
was 4.2 months [112]. One case of transient facial paresis (at
smile) was observed and resolved after 3 months.
Discussion
BTX injection is described as an alternative treatment of
TMD when other non-invasive treatments give unsatisfactory
results. The rst study on botulinum toxin for the treatment
of TMD was conducted by Freund in 1998 [12] but to date
there is no clear consensus regarding the efcacy of this
treatment.
Table I. Age distribution of patients.
<20 4
2129 6
3039 10
4049 8
5059 3
6069 2
7079 1
Table II. Number of injections of botulinum
toxin per patient.
Number of injections Number of patients
117
25
34
42
510 5
>10 1
J Oral Med Oral Surg 2018;24:107-111 A. Kahn et al.
109
We decided to perform injections was performed with
anatomical identication only, favouring the trigger points.
This reproducible technique was used for several reasons.
Freund [18] injected areas with signicant muscle volume and
signicant activity detected during the electromyogram (EMG),
which were not necessarily trigger points. However, numerous
studies highlight the advantages of injecting BTX into trigger
points [16,19,20].
Although the use of EMG is growing rapidly, most authors
use anatomical identication (3/5 in studies by Chen et al.
[17]). The injections were bilateral to avoid muscular
imbalance, which could worsen the symptoms.
A 100-U dose of BOTOX
®
(Allergan) was injected per
patient, with 30 U per masseter and 20 U per temporalis muscle.
In literature [17], BOTOX
®
is used in doses from 100 to 150
units for every muscle. The injection is always intramuscular in
24 sites in each muscle. The efcacy of the injected dose
depends on muscle mass and symptom severity, and there is no
consensus on the optimal dosage [17].
During the follow-up period, the patients were examined
after 3 and 6 months to assess the efcacy of BTX. In literature,
patients are generally controlled after 1 month. Three months
seems to be a suitable interval: at that point, BTX has
disappeared completely, muscle strength is fully recovered, and
it is the minimum period before re-injection [9], to reduce BTX
resistance caused by the production of antibodies [16].
In the present study, 80% of patients reported a signicant
improvement of their symptoms. There was a signicant
improvement of arthralgia, as well as a tendency for myalgia
improvement. However, there was no signicant difference in
mouth opening 3 months after the rst injection. Sidebottom
et al. [20] showed that clinical improvement was not related to
mouth opening improvement.
This is the rst study that indicates the rate improvement
for each symptom. Results are therefore difcult to compare to
the literature data.
Nevertheless, BTX efcacy for symptoms that cause TMD is
thoroughly described. Numerous studies have shown the
benecial effects of BTX for masseter hypercontraction
[15,16], bruxism [21], tension headache [13,14] as well as
pain and myalgia [1214,18].
The most recent reports related to randomised, multicentre
studies comparing facial manipulation [15] or placebo to BTX
injections were contradictory [16,19,22].
Theses studies had signicant biases [17]: performance and
detection biases for the study of Guarda-Nardini et al. [15],
selection and reporting biases for studies of Kurtoglu et al. [19]
and Von Lindern et al. [16].
Conclusion
This study shown that BTX should be considered as an
alternative treatment for TMD when other conservative
methods fail to yield satisfactory results. Randomised clinical
studies with high-quality descriptions of all aspects of the
methodology and results should be conducted in the future by
emphasizing the effect of BTX on different symptoms and
adapting treatments.
Conicts of interests: The authors declare that they
have no conicts of interest in relation to this article.
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... Temporomandibular disorder (TMD) is term used to describe arthrogenic and myofascial disorders that affect the TMJ, sometimes combined (1) . Myofacial TMD is associated with the pain from hyperfunctioning muscles of mastication cause inflammation and localized muscular hypoxia leading to chronic myositis. ...
... Patients were informed of the use of their medical records. Ethical approval for the study was obtained from the ethical committee (1,9) .While, the exclusion criteria included: Subjects giving a history of any known trauma involving TMJ having luxation .Subjects whoever had experienced any extra-articular problem that could cause reduction of mouth opening such as face and neck abscesses or infection were excluded from the study. Subjects with conditions such as Oral Submucous Fibrosis or any surgery in the TMJ region were also excluded from the study (9) . ...
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The diagnosis and treatment of orofacial pain is in many cases a complex task due to difficulties in history taking, multi‑faceted pathology, psychiatric comorbidities and psychosocial factors involved in such pain. Neurologists tend to overdiagnose trigeminal neuralgia. However, other types of neuropathiс orofacial pain are also common. Moreover, neurologists are often unfamiliar with the temporomandibular disorder and tend to neglect this extremely prevalent cause of orofacial pain. Correct understanding of the causes of orofacial pain is vital not only for treatment selection, but also to minimize the risk of adverse events associated with unnecessary madications. Moreover, untreated orofacial pain often becomes chronic and treatment resistant. Many patients in this case would require physical therapy, pharmacological treatments, cognitive behavioral therapy and other support options. The aim of this paper is to review the new International classification of orofacial pain as well as the prevalence, pathophysiology and treatment of the temporomandibular disorder, trigeminal neuralgia, persistent idiopathic facial pain, burning mouth syndrome and other forms of orofacial pain.
... 6 There may be a positive benefit in these patients when conservative management has failed. [7][8][9] We have therefore evaluated our current service provision to assess the effectiveness and patientreported outcomes of treatment with BTX-A in patients with temporomandibular myofascial pain. Our aims were to find out whether BTX-A improved outcomes (including changes in patient-reported pain scores and maximum interincisal distance), to assess the intervals for treatment within our service, and to develop a standard clinical pro forma for the administration of BTX-A to improve the consistency of prescribing and recording of patient-reported outcomes. ...
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The purpose of this work is to present a new, still experimental method of treating temporomandibular disorders (TMD) by injecting botulinum toxin Type A (TBX-A), using its effects not as a toxin but as a medication. The mechanism of TBX-A, indications and contraindications for its use, as well as possible side effects, are discussed. Temporomandibular disorders are of concern to approximately 70-80% of the population. The effect of botulinum toxin depends on blocking the release of acetylcholine from a presynaptic neuromuscular synapse and, in the autonomous system, blocking its release from post-ganglionic cholinergic neurons. In cases of long-term TMJ disorders, muscle activity increases and spastic contractions may even appear. TBX-A offers an opportunity for a normal social and family life for many patients suffering from masticatory system disorders (MSD), who have been isolated from the environment by pain. The study is based on a review of the literature and the authors' own experiences during several attempts to treat patients by this method. TBX-A is a safe medicine when the injection is performed by a well-trained physician.
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Background Pain related to temporomandibular disorders (TMD) is a common problem in modern societies. The aim of the article is to present the concepts of TMD pain clinical management. Methods A survey was performed using the PubMed, SCOPUS and CINAHL databases for documents published between 1994 and 2014. The following search keywords were selected using MeSH terms of the National Library of Medicine in combination: TMD pain, TMD, TMJ, TMJ disorders, occlusal splint, TMD physiotherapy, TMJ rheumatoid disorders and TMJ surgery. Original articles and review papers which presented the clinical relevance and practical validity regarding the possibility of application in TMD management have been included. Authors have excluded articles without outstanding practical aspect and evidence-based background. A first selection was carried out by reviewing titles and abstracts of all articles found according to the criteria. After that the full texts of potentially suitable articles were assessed. In line with these criteria, among 11467 results the writers have included 66 papers. Results The most commonly reported conservative treatments are massage therapy and individually fabricated occlusal splints. In addition to massage, other popular methods include manual therapy and taping, warming/cooling of aching joints, and light and laser therapy. Drugs are also commonly used. In the most severe cases of the temporomandibular joint degeneration, surgical restoration of the joint is sometimes applied. Conclusions The authors concluded that conservative treatment including counselling, exercises, occlusal splint therapy, massage, manual therapy and others should be considered as a first choice therapy for TMD pain because of their low risk of side effects. In the case of severe acute pain or chronic pain resulting from serious disorders, inflammation and/or degeneration pharmacotherapy, minimally invasive and invasive procedures should be considered.
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The objective of this study was to undertake a systematic review to assess the efficacy of botulinum toxin therapy (BTX) for temporomandibular joint disorders (TMDs). A comprehensive search of major databases through PubMed, EMBASE, and Cochrane CENTRAL was conducted to locate all relevant articles published from inception to October 2014. Eligible studies were selected based on inclusion criteria and included English language, peer-reviewed publications of randomized controlled trials comparing BTX versus any alternative intervention or placebo. Quality assessment and data extraction were done according to the Cochrane risk of bias tool and recommendations. The entire systematic search and selection process was done independently by two reviewers. Five relevant study trials were identified, involving 117 participants. Two trials revealed a significant between-group difference in myofascial pain reduction, another trial that compared BTX with fascial manipulation showed equal efficacy of pain relief on TMDs, while the remaining two trials showed no significant difference between the BTX and placebo groups. Because of considerable variations in study methods and evaluation of results, a meta-analysis could not be performed. Based on this review, no consensus could be reached on the therapeutic benefits of BTX on TMDs. A more rigorous design of trials should be carried out in future studies. Copyright © 2015 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.
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We prospectively analysed the outcome after botulinum injection in patients who did not recover after conservative measures to manage masticatory myofascial pain, and who were not willing to take low dose tricyclic antidepressants as a muscle relaxant. We prospectively 62 patients were assessed with visual analogue scores (VAS) for pain on the affected side before, and 6 weeks after botulinum injection(s) (50 units Dysport(®) in up to 3 sites), and measured mouth opening in mm. Of those treated 49 (79%) showed at least some improvement (pain reduced by more than 25%). Patients reported more than a 90% reduction in the VAS for 25 (30%) of the 84 sides of the face treated. Only 22 of the 62 patients had more than one course of treatment to the same side. Interincisal distance improved by a mean/median of 0.9mm (p<0.03) after treatment. Side effects included 3 cases of temporary weakness of a facial muscle. Ranking the VAS pain scores using the Wilcoxon test before and after injection showed a significant reduction in pain (median change -29.5, interquartile range -53 to -16, p<0.0001). The treatment significantly improved patients' pain scores and the overall mean/median reduction in pain was 57%. Botulinum injection does not guarantee complete resolution of myofascial pain, but it usually has some beneficial effect in improving the symptoms, and should be considered as an alternate treatment for masticatory myofascial pain if conservative methods have failed.