Skip to content

Suppression of awake bruxism by using an oral appliance

Efficacy and safety of an oral appliance on suppression of awake bruxism

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs062230112
Enrollment
30
Registered
2024-03-18
Start date
2024-07-24
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

awake bruxism bruxism

Interventions

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.

Sponsors

Kodama Naoki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Cumulative duration of clenching-like mandibular movements per hour with 20% MVC or higher at 14 days after wearing the device

Secondary

MeasureTime frame
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)

Contacts

Public ContactNaoki Kodama

Okayama University Hospital

naoki-k@md.okayama-u.ac.jp+81-86-235-6687

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026