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Systematic review

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Authors Li K , Tan K , Yacovelli A , Bi WG
Journal Journal of oral rehabilitation
Year 2023
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BACKGROUND: Botulinum toxin type A (BTX-A) is increasingly used to manage painful temporomandibular disorders (TMD). However, the effect of BTX-A on muscular TMD remains unclear. OBJECTIVE: To assess the efficacy, safety and optimal dose of BTX-A for treating TMD. METHODS: We conducted systematic literature searches in MEDLINE, Embase, Web of Science, ClinicalTrials.gov and Cochrane Library until March 2023. We extracted data from randomized controlled trials (RCTs) that evaluated the efficacy and safety of BTX-A in treating muscular TMD. We performed a meta-analysis using a random-effects model. RESULTS: Fifteen RCTs involving 504 participants met the inclusion criteria. BTX-A was significantly more effective than placebo in reducing pain intensity, as measured on a 0-10 scale, at 1 month (MD [95% CI] = -1.92 [-2.87, -0.98], p < .0001) and 6 months (MD [95% CI] -2.08, [-3.19 to -0.98]; p = .0002). A higher dosage of BTX-A (60-100 U bilaterally) was associated with a greater reduction in pain at 6 months (MD [95% CI] = -2.98 [-3.52, -2.44]; p < .001). BTX-A also resulted in decreased masseter muscle intensity (μV) (MD [95% CI] = -44.43 [-71.33, -17.53]; p = .001) at 1 month and occlusal force (kg) at 3 months (MD [95% CI] = -30.29 [-48.22 to -12.37]; p = .0009). There was no significant difference in adverse events between BTX-A and placebo. CONCLUSIONS: BTX-A is a safe and effective treatment for reducing pain and improving temporomandibular muscle and joint function in muscular TMD patients. A bilateral dose of 60-100 U might be an optimal choice for treating muscular TMD pain.

Systematic review

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Journal Journal of oral & facial pain and headache
Year 2022
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AIMS: To systematically review the scientific literature for evidence concerning the clinical use of botulinum toxin (BTX) for the management of various temporomandibular disorders (TMDs). METHODS: A comprehensive literature search was conducted in the Medline, Web of Science, and Cochrane Library databases to find randomized clinical trials (RCT) published between 2000 and the end of April 2021 investigating the use of BTX to treat TMDs. The selected articles were reviewed and tabulated according to the PICO (patients/problem/population, intervention, comparison, outcome) format. RESULTS: A total of 24 RCTs were selected. Nine articles used BTX injections to treat myofascial pain, 4 to treat temporomandibular joint (TMJ) articular TMDs, 8 for the management of bruxism, and 3 to treat masseter hypertrophy. A total of 411 patients were treated by injection of BTX. Wide variability was found in the methods of injection and in the doses injected. Many trials concluded superiority of BTX injections over placebo for reducing TMD pain levels and improving maximum mouth opening; however, this was not universal. CONCLUSION: There is good scientific evidence to support the use of BTX injections for treatment of masseter hypertrophy and equivocal evidence for myogenous TMDs, but very little for TMJ articular disorders. Studies with improved methodologic design are needed to gain better insight into the utility and effectiveness of BTX injections for treating both myogenous and TMJ articular TMDs and to establish suitable protocols for treating different TMDs.

Systematic review

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Journal British Journal of Oral and Maxillofacial Surgery
Year 2022
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PURPOSE: The purpose of this study is to explore the treatment efficacy of botulinum-A (BTX-A) in nocturnal bruxism. MATERIALS AND METHODS: Five electronic databases (PubMed, Web of Science, Cochrane, Embase and Clinical Trials) were searched to identify related randomized controlled trials through September 1, 2020. Five evaluation indexes were extracted, namely, the pain at rest and at chewing (PR and PC), the number of bruxism events (NBEs) and the self-assessment by patients (SA), to assess the treatment efficacy of BTX-A in bruxism. All data analyses were conducted using Review Manager (Version 5.3; The Cochrane Collaboration, London, United Kingdom). RESULT: Six studies were included in this review. The sample was composed of 148 participants. Compared with the placebo group, the BTX-A group showed the significantly improved the PR index scores (MD, 1.16 cm; 95%CI, 0.65 to 1.67 cm; P < 0.00001), slightly improved the PC index scores (SMD, 0.25; 95%CI -0.14 to 0.64; P = 0.21), and the NBEs were significantly decreased in the before-injection group compared with that in the after-injection group (MD, 1.72; 95%CI, 0.60 to 2.85; P = 0.003). CONCLUSIONS: The results of this study suggest that BTX-A possesses significant therapeutic efficiency for the relief of pain and events of bruxism. However, whether the events of bruxism would recur or rebound after botulinum toxin injection needs more follow-up clinical evidence.

Systematic review

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Journal The Journal of prosthetic dentistry
Year 2021
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STATEMENT OF PROBLEM: Botulinum toxin has been used for various therapeutic and esthetic purposes for nearly 4 decades and has shown positive outcomes in patients with bruxism. However, the effectiveness of botulinum toxin injections as an alternative to traditional therapies in the management of primary bruxism is still unclear. PURPOSE: The purpose of this systematic review was to analyze the clinical outcomes of the use of botulinum toxin type A injections in the management of primary bruxism in adults. MATERIAL AND METHODS: Databases such as PubMed, Web of Science, Scopus, LILIACS, Cochrane Library, and Open Grey Literature were searched without language or date restrictions until October 6, 2019. Using Mendeley Desktop software to organize the references, 2 independent researchers selected the published clinical studies (Study type) on the improvement of symptoms (Outcome) in human adults with primary bruxism (Participants/Population) who received botulinum toxin type A injections (Intervention), placebo injections, saline injections, no injections, or other treatments (Comparator(s)/Control) for the management of bruxism. RESULTS: A total of 601 references were initially obtained from the 6 databases. Six randomized clinical trials and 4 case series were selected and critically appraised according to the Fowkes and Fulton guidelines. Heterogeneity among the studies did not allow for a meta-analysis. All studies supported the efficacy and safety of botulinum toxin injections in reducing the symptoms of primary bruxism. CONCLUSIONS: Botulinum toxin type A injections are effective in the treatment of the symptoms of primary bruxism in adults. Randomized clinical trials are still needed to establish a protocol for using botulinum toxin as an alternative to traditional therapies in the management of primary bruxism.

Systematic review

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Journal Br. J. Oral Maxillofac. Surg.
Year 2020
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The aim of this review was to critically investigate and assess the evidence relating to the use and efficacy of botulinum toxin (BTX) in the management of temporomandibular joint disorders (TMD) and masticatory myofascial pain. A comprehensive search was conducted of PubMed, Scopus, Embase, and Cochrane CENTRAL, to find relevant studies from the last 30 years up to the end of July 2018. Seven were identified. Three showed a significant reduction in pain between the BTX and placebo groups and one showed a clinical, but not a significant, difference. In one that compared BTX with another novel treatment, myofascial pain reduced equally in both groups, and in the remaining two there was no significant difference in pain reduction between the BTX and control groups. Of the four studies that assessed mouth opening, two reported that BTX had resulted in a slight improvement; one reported no improvement, and the other a worsening of the condition. A meta-analysis was not possible because of the considerable variation in the studies' designs, the heterogeneity between the groups, and the different assessment tools used. Despite showing benefits, consensus on the therapeutic benefit of BTX in the management of myofascial TMD is lacking. Further randomised controlled trials with larger sample sizes, minimal bias, and longer follow-up periods are now needed.

Systematic review

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Journal The journal of pain : official journal of the American Pain Society
Year 2020
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This systematic review investigated the effectiveness and safety of botulinum toxin type A (BTX-A) for painful temporomandibular disorders. We searched for randomized controlled trials (RCTs) in ten databases, from inception to February 12, 2019 (MEDLINE, EMBASE, CENTRAL, LILACS, BBO, Web of Science, Scopus, ClinicalTrials.gov, WHO and OpenGrey). We included 12 RCTs that compared BTX-A versus inactive or active interventions. BTX-A was slightly more effective than placebo for pain reduction at one month: mean difference (MD) -1.74 points (0 to 10 scale), 95% confidence interval (CI) -2.94 to -0.54, 3 RCTs, 60 participants, I-square (I2) = 0%. However, there were no significant differences at three and six months. BTX-A was similar to no treatment for pain reduction at three and six months. BTX-A was more effective than conventional treatment and low level laser therapy for pain reduction at one, six and 12 months, but less effective than facial manipulation for pain reduction at three months. BTX-A was not associated with a significant increase in the risk of adverse events. The quality of the evidence was low and results are insufficient to support the use of BTX-A for painful temporomandibular disorders. High quality RCTs are needed to increase confidence in effect estimates. PERSPECTIVE: BTX-A for painful temporomandibular disorders appears to be well tolerated. For pain reduction, BTX-A is slightly more effective than placebo only at one month; conventional treatment and low-level laser at one, six and 12 months. Low quality evidence limits the applicability of these findings and precludes recommendations for practice.

Systematic review

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Journal Journal of oral rehabilitation
Year 2020
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OBJECTIVE: A network meta‐analysis (NMA) of randomised clinical trials (RCTs) was performed aiming to compare the treatment outcome of dry needling, acupuncture or wet needling using different substances in managing myofascial pain of the masticatory muscles (TMD‐M). METHOD: An electronic search was undertaken to identify RCTs published until September 2019, comparing dry needling, acupuncture or wet needling using local anaesthesia (LA), botulinum toxin‐A (BTX‐A), granisetron, platelet‐rich plasma (PRP) or passive placebo versus real active placebo in patients with TMD‐M. RCTs meeting the inclusion criteria were stratified according to the follow‐up time: immediate post‐treatment to 3 weeks, and 1 to 6 months post‐treatment. Outcome variables were post‐treatment pain intensity, increased mouth opening (MMO) and pressure threshold pain (PPT). The quality of evidence was rated according to Cochrane's tool for assessing risk of bias. Mean difference (MD) was used to analysed via frequentist NMA using Stata software. RESULTS: Twenty‐one RCTs involving 959 patients were included. The quality of evidence of the included studies was low or very low. There was significant pain decrease after PRP when compared to an active/passive placebo and acupuncture. There was a significant improvement of MMO after LA (MD = 3.65; CI: 1.18‐6.1) and dry needling therapy (MD = 2.37; CI: 0.66‐4) versus placebo. The three highest ranked treatments for short‐term post‐treatment pain reduction in TMD‐M (1‐20 days) were PRP (95.8%), followed by LA (62.5%) and dry needling (57.1%), whereas the three highest ranked treatments at intermediate‐term follow‐up (1‐6 months) were LA (90.2%), dry needling (66.1%) and BTX‐A (52.1%) (all very low‐quality evidence). LA (96.4%) was the most effective treatment regarding the increase in MMO followed by dry needling (72.4%). CONCLUSION: Based on this NMA, one can conclude that the effectiveness of needling therapy did not depend on needling type (dry or wet) or needling substance. The outcome of this NMA suggests that LA, BTX‐A, granisetron and PRP hold some promise as injection therapies, but no definite conclusions can be drawn due to the low quality of evidence of the included studies. This NMA did not provide enough support for any of the needling therapies for TMD‐M.

Systematic review

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Authors Patel J , Cardoso JA , Mehta S
Journal British dental journal
Year 2019
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Introduction The medical and cosmetic use of botulinum toxin (BTX) is now widespread. With an increased number of clinicians adopting the use of BTX in the management of temporomandibular disorders (TMD) and/or bruxism, as either a standalone treatment or as an adjunct, affirmation is required in regards to whether it has a clinically justifiable position among the current spectrum of available treatment modalities.Objectives To establish the usefulness of BTX when treating patients with TMD and/or bruxism, and thereby determine whether there may be an appropriate purpose for the prescription of BTX in the management of these patients.Data sources and data selection A systematic review of the relevant literature was conducted. The literature search was carried out by applying key terms to appropriate data sources (Medline, Embase, Pubmed, Cochrane Central Register of Controlled Trials, and OpenSIGLE). The resultant papers were subjected to inclusion and exclusion criteria, which were then assessed for bias using a framework outlined in the Cochrane Handbook.Results A total of 11 trials met the inclusion criteria. The primary outcome measure was changes in pain experience in groups that had been treated with BTX, relative to an appropriate control group. Secondary outcomes included changes in the frequency of bruxism events, changes in maximum mouth opening, changes in occlusal force and changes in electromyography (EMG) readings of muscles of mastication.Conclusion The evidence to support the use of BTX in the management of TMD and/or bruxism is not entirely unequivocal. A number of studies that have met the inclusion criteria have shown promising results and thereby justify further investigation. Given the current evidence, BTX should certainly be considered but due to financial implications and possible side effects, it seems appropriate that conservative options, such as self-management with explanation and physical therapies, should be exhausted first.

Systematic review

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Journal Clinical oral investigations
Year 2019
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OBJECTIVES: The objective of the study was to conduct a systematic review of literature assessing botulinum toxin type A (BoNT-A) safety and adverse effects in the treatment of myofascial pain (MFP) and trigeminal neuralgia (TN). MATERIALS AND METHODS: The search for articles by two specific researchers involved the PubMed, EMBASE, Web of Science, and Scopus databases. Specific terms were used, and no publication time and language restrictions were applied. Clinical trials that investigated the effects of BoNT-A among participants with myofascial pain in masticatory muscles or trigeminal neuralgia were considered eligible for this systematic review. Data for each study were extracted and analyzed according to a PICO-like structured reading. RESULTS: The search strategy provided 436 citations. After analysis, 16 citations were included, seven for MFP and nine for TN. In all studies, BoNT-A was well tolerated and improved pain. The most common adverse effects were temporary regional weakness, tenderness over the injection sites, and minor discomfort during chewing. Most studies reported a spontaneous resolution of adverse effect. CONCLUSIONS: It can be concluded that BoNT-A treatment is well tolerated, since minor adverse effects were the most frequently reported; however, it is recommended that future studies aim to assess the safety and possible adverse effects of multiples applications or high doses of this treatment. CLINICAL RELEVANCE: BoNT-A has been increasingly diffused in dentistry, being used for the management of masticatory myofascial pain and trigeminal neuralgia. Nonetheless, there is no consensus about its efficacy and adverse effects that could occur when this treatment is applied.

Systematic review

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Journal Medicina oral, patologia oral y cirugia bucal
Year 2019
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Background: Currently it has been shown that botulinum toxin is effective for a wide variety of medical conditions, and can be applied for therapeutic purposes as cosmetic. In recent years, there has been a growing trend in the use of this drug substance to control the muscular overactivity of bruxism. The objective of this study was the use of botulinum toxin type A (BTX-A) than traditional methods, by conducting a systematic review of randomized clinical trials (RCTs) published in the health sciences literature. Material and methods: An electronic search was made in the databases of the PubMed, Cochrane Library and Scopus data between March and October 2017, ECA, which will analyze the effect of botulinum toxin in the treatment of bruxism. We included studies of bruxist patients older than 18 years where BTX-A tests were performed on the masseter and / or temporal muscles and the control systems were injections of placebo (saline) or the use of traditional methods for the treatment of bruxism. such as occlusal splints, other medications or cognitive-behavioral therapy. Results: Of the 68 studies identified, 4 RCTs that fit our inclusion criteria were selected. These studies show that BTX-A injections can reduce the frequency of bruxism episodes, decrease pain levels and maximum occlusal force generated by this pathology, offer superior efficacy in the treatment of bruxism compared to control groups who were treated with placebo or with traditional methods for the treatment of bruxism. Conclusion: Infiltrations with BTX-A are a safe and effective treatment for patients with bruxism, so its use is justified in daily clinical practice, especially in patients diagnosed with severe bruxism