Comparison between botulinum toxin type A injection on masseter muscle only and additional injection on anterior belly of digastric muscle in sleep bruxism patients: a clinical trial
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0008721
- Lead Sponsor
- Yonsei University Health System, Dental Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The change of bite force and muscle thickness after 4 weeks
- Secondary Outcome Measures
Name Time Method The change of bite force and muscle thickness after 8 weeks