UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015029 |
|---|---|
| Receipt number | 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 21:23:38 |
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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
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
h.m@dent.kyushu-u.ac.jp
Sponsor or person
Institute
Faculty of Dental Science, Kyushu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017457
