Suppression of awake bruxism by using an oral appliance

JRCT ID: jRCTs062230112

Registered date:18/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: awake bruxism
• Date of first enrollment: 24/07/2024
• Target sample size: 30
• Study type: Interventional
• Intervention(s): An intraoral device for suppressing bruxism is worn in the mouth every day from after waking up until before going to bed, except during meals.

Outcome(s)

• Primary Outcome: Cumulative duration of clenching-like mandibular movements per hour with 20% MVC or higher at 14 days after wearing the device

Secondary Outcome

1.Cumulative duration of clenching-like movements per hour with 20% MVC or higher 28 days and 42 days after the intervention and 28 days after the end of the intervention period
2.Mandibular movement patterns of the stomatognathic system other than those mentioned above
3.Aggregation of adverse events and problems (discomfort due to wearing oral appliances, dry mouth, stomatitis, dental caries, worsening of periodontal disease, toothache, worsening of temporomandibular joint symptoms, and problems of oral appliances recorded on the recording sheet)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. patiets who are 20 years old or older at the timing of obtaining consent (regardless of gender)
2. as a result of the screening test, those who have 4 or more clenching-like movements per hour with more than 20% of Maximum Voluntary Clenching
3. patients who have received sufficient explanation and have given written informed consent of their own free will to participate in this research with full understanding.

Exclude criteria

1.patient who complains of occlusal changes with the onset of symptoms that motivates them to visit an outpatient clinic for temporomandibular disorders
2.patient who have experienced symptoms such a s rough skin or itching due to the resin or wire used to attach the device
3.patient who have difficulty following instructions regarding use and return of the equipment
4.patients who are taking drugs that have the effect of suppressing bruxism (proton pump inhibitors, antiepileptic drugs, dopamine agonists, etc.)
5.patient whom principal investigator considered inappropriate to partipate in this study

Related Information

• Primary Sponsor: Kodama Naoki