UMIN-CTR Clinical Trial

Basic information
Public title	The short-term inhibiting effect of occlusal splint with contingent vibratory stimulus on sleep bruxism
Acronym	The short-term effect of contingent vibratory stimulus for sleep bruxism inhibition
Scientific Title	The short-term inhibiting effect of occlusal splint with contingent vibratory stimulus on sleep bruxism
Scientific Title:Acronym	The short-term effect of contingent vibratory stimulus for sleep bruxism inhibition
Region	Japan

Condition
Condition	Sleep bruxism
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the short-term effects of vibration stimulation on sleep bruxism and sleep quality.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Masseter muscle EMG during sleep
Key secondary outcomes	Total sleep time, EEG, sleep stage, micro arousal, subjective evaluation for deep sleep

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	The subjects are monitored masseter muscle EMG overnight wearing the occlusal splint with vibratory stimulus generator after one night habituation of the splint. The vibratory stimulus is set to occur when the electric signal from the intra-splint force detector surpasses 15% of the maximum voluntary contraction level and is scheduled to be applied intermittently for 30 min, with 30 min-intervals.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	Students or faculties who belong to the university or university dental hospital Presence of occlusal contact with natural dentition Those who gave written informed consent in first-person
Key exclusion 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 Presence of major neurological or psychiatric disorders Presence of Sleep disorder (e.g., sleep apnea syndrome, narcolepsy)
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Masayuki Middle name Last name Takaba
Organization	Showa University
Division name	Department of Prosthodontics
Zip code	145-8515
Address	2-1-1, Kitasenzoku, Ota-ku, Tokyo, JAPAN
TEL	03-3787-1151
Email	mtakaba@dent.showa-u.ac.jp

Public contact
Name of contact person	1st name Yuka Middle name Last name Abe
Organization	Showa University
Division name	Department of Prosthodontics
Zip code	152-0001
Address	2-1-1, Kitasenzoku, Ota-ku, Tokyo, JAPAN
TEL	03-3787-1151
Homepage URL
Email	abeyuka@dent.showa-u.ac.jp

Sponsor
Institute	Department of Prosthodontics, Showa University
Institute
Department

Funding Source
Organization	The Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)	Showa University

IRB Contact (For public release)
Organization	Ethics Committee of Showa University
Address	2-1-1 Kitasenzoku, Ota-ku, Tokyo, Japan
Tel	0337871151
Email	funabata@ofc.showa-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 04 Day

Related information
URL releasing protocol	https://doi.org/10.1007/s11325-019-01782-x
Publication of results	Published

Result
URL related to results and publications	https://doi.org/10.1007/s11325-019-01782-x
Number of participants that the trial has enrolled	13
Results	The number of SB episodes tended to decrease with the vibration stimuli, and the decrease in the total SB duration was statistically significant (14.3 +- 9.5 vs. 26.0 +- 20.0, p = 0.03). No substantial change was found in terms of the micro-arousal index.
Results date posted	2022 Year 06 Month 09 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2019 Year 01 Month 26 Day
Baseline Characteristics	Sleep bruxism
Participant flow	After making a clinical diagnosis based on clinical symptoms, sleep bruxism-related masticatory muscle activity was examined for a definitive diagnosis. Experiments were then performed.
Adverse events	None
Outcome measures	The number of SB episodes (times/hour) The total SB duration (seconds/hour) The mean duration of SB episodes (seconds/episode) The micro-arousal index (times/hour)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 16 Day
Date of IRB	2014 Year 04 Month 01 Day
Anticipated trial start date	2015 Year 04 Month 09 Day
Last follow-up date	2018 Year 06 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 05 Month 30 Day
Last modified on	2022 Year 06 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037352