None listed
Conditions
Interventions
Drug : A dose of 25 U of BoNT-A(NABOTA) was injected into each masseter muscle using a 1-mL syringe with a 29-gauge, 0.5-inch needle. BoNT-A was injected into two sites of each subject’s masseter musc
Sponsors
Yonsei University Health System, Dental Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult male and female subjects at the age of = 18 years old 2) The subjects had the following clinical signs and symptoms for SB: (1) a history of tooth grinding occurring at least three3 nights per week; (2) experience of morning jaw stiffness; and (3) clinical presence of tooth wear. 3) Subject who have signed the written informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1) Previous treatment with botulinum toxin of any serotype into both the masseter and the temporalis muscles for the past one year 2) Patients with sleep bruxism appearing as part of Mandibular dyskinesia, dystonia 3) Patients with sleep bruxism that appear as brain damage or drugs 4) Medical condition that may affect neuromuscular function (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis) 5) Patients who take certain medications like Aminoglycoside antibiotics, curare-like agents, or drugs that inhibit neuromuscular function (muscle relaxers, anticholinergic, benzodiazepines, benzamides, tetracyclines, lincomycins, etc.) within 4 weeks prior to screening visit 6) Known allergy or hypersensitivity to botulinum toxin preparation 7) Female who are pregnant, lactating, or likely to become pregnant, and who are not willing to use an acceptable form of contraception. 8) Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study 9) Participation in another interventional clinical study within the last 30 days or 5 half-lives of the drug, whichever is longer, of entry into this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of Sleep bruxism episode variables after 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| The change of Sleep bruxism episode variables after 12 weeks | — |
Countries
Korea, Republic of
Contacts
Public ContactSeong Taek Kim
Yonsei University Health System, Dental Hospital
Outcome results
None listed