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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015029
Receipt No. R000017457
Scientific Title Study of effective treatment protocols of occlusal splint devices on sleep bruxism.
Date of disclosure of the study information 2014/09/02
Last modified on 2015/05/09

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Basic information
Public title Study of effective treatment protocols of occlusal splint devices on sleep bruxism.
Acronym Study of effective treatment protocols of occlusal splint devices on sleep bruxism.
Scientific Title Study of effective treatment protocols of occlusal splint devices on sleep bruxism.
Scientific Title:Acronym Study of effective treatment protocols of occlusal splint devices on sleep bruxism.
Region
Japan

Condition
Condition Bruxism
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of the difference in usage of stabilisation splints on sleep bruxism.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Masseter muscle activity.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Subject used splints every other week, i.e., at the 1st to 7th, 15th to 21st, and 29th nights
Interventions/Control_2 Subjects used splints continuously during sleep for 29 nights
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

Not applicable
Gender Male and Female
Key inclusion criteria Students and staff of Kyushu University.
(i) fulfilling the diagnostic criteria of SB from the American Academy of Sleep Medicine (AASM): reporting tooth-grinding or clenching in combination with at least one of the following conditions: abnormal tooth wear; sounds associated with bruxism; and jaw muscle discomfort, and (ii) in good general health.
Key exclusion criteria (i) more than two missing posterior teeth excluding third molars; (ii) use of a removable prosthesis; (iii) existence of TMD problems according to the research diagnostic criteria for TMD (RDC/TMD) [26]; (iv) use of medication with possible effects on sleep or motor behaviour; (v) alcohol or drug abuse; (vi) on-going physical or dental therapy including orthodontic treatment; (vii) major neurological or psychiatric disorders; and (viii) sleep disorders.
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoshi Koyano
Organization Faculty of Dental Science, Kyushu University
Division name Section of Implant and Rehabilitative Dentistry, Division of Oral Rehabilitation
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL 092-642-6441
Email koyano@dent.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Matsumoto
Organization Faculty of Dental Science, Kyushu University
Division name Section of Implant and Rehabilitative Dentistry, Division of Oral Rehabilitation
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL 092-642-6441
Homepage URL
Email h.m@dent.kyushu-u.ac.jp

Sponsor
Institute Faculty of Dental Science, Kyushu University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2014 Year 09 Month 02 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 10 Month 08 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 09 Month 02 Day
Last modified on
2015 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017457

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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