Pilot study on the evaluation of bite force following botulinum toxin injection of the anterior belly of the digastric muscle (one of the chewing muscles located under the jaw and used to open the mouth) in a bruxism patient

Yonsei University Health System, Dental Hospital0 sites24 target enrollmentStarted: TBDLast updated: August 21, 2023

Trial Snapshot

No summary available.

•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.

•1) Patients who have received other treatments for bruxism, such as splints or botulinum toxin injections.
•2) patients with hypersensitivity reactions to serum albumin.
•3) Patients taking medications that affect the central nervous system, such as antidepressants, anxiolytics, and antiepileptic drugs.
•4) Patients with more than two missing molars (excluding third molars).
•5) Patients with severe malocclusion (including anterior open bite).
•6) Patients with no history of orthodontic treatment or currently undergoing orthodontic treatment.
•7) Patients with a history of trauma in the temporomandibular joint (TMJ) area.
•8) Patients with TMJ disc displacement.
•9) Patients diagnosed with systemic diseases that may affect the temporomandibular joint (e.g., osteoarthritis).
•10) Patients with allergies, skin cancer, or other skin disorders related to ultrasound gel.
•11) Pregnant, lactating, or underage individuals.
•12) Other patients deemed inappropriate by the clinical physician's judgment.

Sponsor

Yonsei University Health System, Dental Hospital