Effects of splint guidance on muscle activity during sleep

JRCT ID: jRCT1032240493

Registered date:19/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Sleep bruxism
• Date of first enrollment: 19/11/2024
• Target sample size: 120
• Study type: Interventional
• Intervention(s): Application of occlusal splints with two different types of guidance (canine guidance, bilateral balanced occlusion) in patients with sleep bruxism.

Outcome(s)

• Primary Outcome: Masseter EMG activity per hour of sleep

Secondary Outcome

Number and duration of masseter EMG episodes per hour of sleep
Total sleep time, percentage of each sleep stage
Score of Pittsburgh Sleep Quality lndex
NRS score of symptoms on waking
NRS score of usability of the occlusal splint

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 40age old
• Gender: Both

Include criteria

Between 18 and 40 years of age
Dentists working in Showa University Dental Hospital or students in Showa University

Exclude criteria

Two or more missing molars, excluding third molars
Use of removable dentures
Ongoing physical or dental therapy, including orthodontic treatment
Use of medication with possible effects on sleep
Alcohol or drug abuse
Those who have a neurological or psychiatric disease
Those who have sleep disorders excluding SB
Those who have difficulty measuring sleep bruxism at home
Those who are deemed by the research physician to be ineligible for participation in the study
Those who have a history of hypersensitivity such as rash or dermatitis to methacrylate polymers
Those whose Screening measurement results show that the number of muscle activity events per unit time is less than 7.6

Related Information

• Primary Sponsor: Takaba Masayuki
• Secondary Sponsor: Baba Kazuyoshi
• Source(s) of Monetary Support: Japan Society for the Promotion of Science