Dataset Information

Botulinum Toxin Therapy for Managing Sleep Bruxism: A Randomized and Placebo-Controlled Trial.

ABSTRACT: The purpose of this study is to evaluate the effects of botulinum toxin type A (BoNT-A) for managing sleep bruxism (SB) in a randomized, placebo-controlled trial. Thirty SB subjects were randomly assigned into two groups evenly. The placebo group received saline injections into each masseter muscle, and the treatment group received BoNT-A injections into each masseter muscle. Audio-video-polysomnographic recordings in the sleep laboratory were made before, at four weeks after, and at 12 weeks after injection. Sleep and SB parameters were scored according to the diagnostic and coding manual of American Academy of Sleep Medicine. The change of sleep and SB parameters were investigated using repeated measures analysis of variance (RM-ANOVA). Twenty-three subjects completed the study (placebo group 10, treatment group 13). None of the SB episode variables showed a significant time and group interaction (p > 0.05) except for electromyography (EMG) variables. The peak amplitude of EMG bursts during SB showed a significant time and group interaction (p = 0.001). The injection decreased the peak amplitude of EMG bursts during SB only in the treatment group for 12 weeks (p < 0.0001). A single BoNT-A injection cannot reduce the genesis of SB. However, it can be an effective management option for SB by reducing the intensity of the masseter muscle.

SUBMITTER: Shim YJ

PROVIDER: S-EPMC7150956 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Botulinum Toxin Therapy for Managing Sleep Bruxism: A Randomized and Placebo-Controlled Trial.

Shim Young Joo YJ Lee Hee Jin HJ Park Keun Jeong KJ Kim Hyung Tack HT Hong Il Hee IH Kim Seong Taek ST

Toxins 20200309 3

The purpose of this study is to evaluate the effects of botulinum toxin type A (BoNT-A) for managing sleep bruxism (SB) in a randomized, placebo-controlled trial. Thirty SB subjects were randomly assigned into two groups evenly. The placebo group received saline injections into each masseter muscle, and the treatment group received BoNT-A injections into each masseter muscle. Audio-video-polysomnographic recordings in the sleep laboratory were made before, at four weeks after, and at 12 weeks af ...[more]

PMID: 32182879

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Project description:BackgroundThe available treatment options fail to provide definitive or curative management for bruxer patients rehabilitated with implant overdentures (OD). The data regarding Botulinum toxin (BTX) injection as a management strategy for bruxism remains unclear. This randomized, single-blinded, control-group, pretest-posttest prospective trial evaluated the occlusal guard and Botox injections (BTX) effectiveness in managing sleep bruxism (SB) in subjects whose one of the edentulous arches had been restored with the implant-supported OD.MethodsForty-two patients diagnosed with definite bruxism were selected, all of which had implant-retained ODs opposing natural dentition. The participants were allocated randomly to three equal groups. Participants in group I (control group) were instructed to remove the OD at night; group II was managed with conventional occlusal stents. Those in group III were given BTX injections. New ODs were constructed for all groups, and all ball attachments were replaced with a new nylon cap. A baseline assessment (one month of OD insertion) of patient satisfaction and sleep quality was conducted, and then again at 3, 6, 9, and 12 months of treatment. Subjective sleep quality was evaluated using Pittsburgh Sleep Quality Index (PSQI). Patients' satisfaction was evaluated using Temporomandibular disorders/numeric scales (TMD/NS). Prosthodontic (mechanical) complications were recorded during the follow-up period.ResultsGroup III showed a statistically significant improvement in patient satisfaction and sleep quality compared to the other two groups at 3, 6, 9, and 12 months follow-up period ( P = 0 0.001, 0.0001, 0.0013, and 0.0001 respectively). Regarding prosthodontic (mechanical) complications, the highest number of events was revealed in the control group.ConclusionsBTX and occlusal appliances effectively improve patient satisfaction and sleep quality of Bruxer patients rehabilitated with single arch implant overdentures.

Project description:ObjectiveEvaluate safety and efficacy of Incobotulinumtoxin A in elderly patients with dementia and paratonia.SettingUniversity-affiliated hospital, spasticity management Clinic.ParticipantsTen subjects were enrolled.Inclusion criteria1) severe cognitive impairment 2) diagnosis of Alzheimer's disease, vascular dementia, or frontotemporal dementia, and 3) score >3 on the paratonic assessment instrument, with posture in an arm(s) interfering with provision of care.Exclusion criteria1) alternate etiologies for increased tone and 2) injection with botulinum toxin within the 6 months preceding the study.DesignSingle center, randomized, double blind, placebo-controlled, crossover trial with two treatment cycles of 16 weeks. Assessments occurred at 2, 6, 12 and16 weeks following injections. Subjects received up to 300 U of Incobotulinumtoxin A in arm(s).Primary and secondary outcome measuresPrimary outcome measure was the modified caregiver burden scale (mCBS); exploratory secondary outcome measures were also performed. Analysis of variance and mixed modeling techniques were used to evaluate treatment effects.ResultsIncobotulinumtoxin A treatment produced significant improvement in mCBS total score -1.11 (-2.04 to -0.18) (Treatment effect and 95% CI), dressing sub-score -0.36 (-0.59 to 0.12), and cleaning under the left and right armpits sub-score -0.5 (-0.96 to -0.04), -0.41 (-0.79 to -0.04) respectively. PROM in the left and right elbow increased by 27.67 degrees (13.32-42.02) and 22.07 degrees (9.76-34.39) respectively. PROM in the left and right shoulder increased by 11.92 degrees (5.46-18.38) and 8.58 degrees (3.73-13.43) respectively. No significant treatment effect was found for GAS, VAS and PAINAD scales or change in time to perform care. No adverse drug reactions occurred.ConclusionsAdministration of Incobotulinumtoxin A in elderly people with advanced dementia and paratonia may be an efficacious and safe treatment to increase range of motion and reduce functional burden. Further studies are needed to confirm results.Trial registrationClinicalTrials.Gov NCT02212119.

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Dataset Information

Botulinum Toxin Therapy for Managing Sleep Bruxism: A Randomized and Placebo-Controlled Trial.

Publications

Botulinum Toxin Therapy for Managing Sleep Bruxism: A Randomized and Placebo-Controlled Trial.

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