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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0008721

Enrollment

Registered

2023-08-18

Start date

2022-03-31

Completion date

Unknown

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : 100 units of botulinum toxin(BoNT) type A (Nabota®) were dissolved in 4ml of normal saline, and 4U per 0.1ml was administered to subjects who met the selection criteria for the sc

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) 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.

Design outcomes

Primary

Measure	Time frame
The change of bite force and muscle thickness after 4 weeks	—

Secondary

Measure	Time frame
The change of bite force and muscle thickness after 8 weeks	—

Countries

Korea, Republic of

Contacts

Public Contactsoo-bin kim

Yonsei University Health System, Dental Hospital

tnqls1128@yuhs.ac+82-2-2228-3069

Outcome results