The inhibiting effect of oral appliance with contingent vibratory stimulus on teeth grinding

JRCT ID: jRCTs032220401

Registered date:21/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Sleep bruxism
• Date of first enrollment: 21/10/2022
• Target sample size: 38
• Study type: Interventional
• Intervention(s): Application of occlusal splint with contingent vibratory stimulus for sleep bruxism patients

Outcome(s)

• Primary Outcome: Duration of SB event
• Secondary Outcome: subjective evaluation for deep sleep, usability of the occlusal splint

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 40age old
• Gender: Both

Include criteria

Between 20 and 40 years of age
Presence of occlusal contact with natural dentition
Those who diagnosed with sleep bruxism by clinical assessment and miniature wearable electromyogram devices.

Exclude criteria

Two or more missing molars, excluding third molars
Use of removable prosthesis
Use of medication with possible effects on sleep or motor behavior
Alcohol or drug abuse
Ongoing physical or dental therapy, including orthodontic treatment
Those who have a neurological or psychiatric disease
Those who have sleep disorders
Those who have difficulty measuring sleep braxism at home
Those who are deemed by the research physician to be ineligible for participation in the study

Related Information

• Primary Sponsor: Takaba Masayuki
• Secondary Sponsor: Baba Kazuyoshi