UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032792
Receipt No. R000037352
Official scientific title of the study The short-term inhibiting effect of occlusal splint with contingent vibratory stimulus on sleep bruxism
Date of disclosure of the study information 2018/06/04
Last modified on 2018/05/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study The short-term inhibiting effect of occlusal splint with contingent vibratory stimulus on sleep bruxism
Title of the study (Brief title) 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 Masayuki Takaba
Organization Showa University
Division name Department of Prosthodontics
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 Yuka Abe
Organization Showa University
Division name Department of Prosthodontics
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

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

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2014 Year 12 Month 16 Day
Anticipated trial start date
2015 Year 04 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

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


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.