Analgesic effect of botulinum toxin on muscle pain in temporomandibular disorder patients : A randomized, double-blind, placebo-controlled pilot study

Yonsei University Health System, Dental Hospital0 sites21 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

November 13, 2021

Last Updated

2 years ago

Study Type

Interventional Study

Sex

All

Sponsor

Yonsei University Health System, Dental Hospital

•1\) Adult men and women aged 19 years or older
•2\) Those who visited Yonsei University Dental Hospital and were diagnosed with masticatory muscle pain in temporomandibular disorder
•3\) Those who fully understand the contents of this study and voluntarily sign the consent form

•1\) patients who received the injection of botulinum toxin within a year or myofascial trigger point injection, such as lidocaine, procaine, or bupivacaine, within a month based on screening
•2\) patients whose pain was caused by a disc or joint\-related disease
•3\) Medical condition that may affect neuromuscular function (e.g., myasthenia gravis, Eaton\-Lambert syndrome, amyotrophic lateral sclerosis)
•4\) 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
•5\) patients diagnosed with or treated for fibromyalgia
•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