UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015032 |
|---|---|
| Receipt number | R000017487 |
| Scientific Title | The effect of stabilization splints on masticatory muscle pain and sleep bruxism: A randomized controlled trial. |
| Date of disclosure of the study information | 2014/09/02 |
| Last modified on | 2016/03/11 11:39:27 |
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Basic information
Public title
The effect of stabilization splints on masticatory muscle pain and sleep bruxism: A randomized controlled trial.
Acronym
ect of stabilization splints on masticatory muscle pain and sleep bruxism: A randomized controlled trial.
Scientific Title
The effect of stabilization splints on masticatory muscle pain and sleep bruxism: A randomized controlled trial.
Scientific Title:Acronym
ect of stabilization splints on masticatory muscle pain and sleep bruxism: A randomized controlled trial.
Region
| Japan |
Condition
Condition
Temporomandibular disorder
Bruxism
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of the stabilisation splints on temporomandibular disorder and 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
Subjects used splints continuously during sleep for 6 weeks, and received cognitive-behavioural therapy
Interventions/Control_2
Subjects received cognitive-behavioural therapy only
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
| 19 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) fulfilling the criteria of myofascial pain according to the research diagnostic criteria for TMD (RDC/TMD) ; (2) reporting tooth-grinding sounds or clenching in combination with at least one of the following conditions: abnormal tooth wear; jaw muscle discomfort; masseter muscle hypertrophy ; (3) in good general health; and (4) aged more than 19 years old.
Key exclusion criteria
(1) TMD patients mainly complaining about joint disorders; (2) systemic joint disease such as rheumatoid arthritis; (3) more than two missing posterior teeth excluding third molars (4) use of medication with possible effects on sleep or motor behavior; (5) alcohol or drug abuse; (6) major neurological or psychiatric disorder; and (7) sleep disorder.
Target sample size
30
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 | Yoshihiro Tsukiyama |
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
tsuki@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
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
This study investigated the effect of stabilisation splints on masticatory muscle pain and sleep bruxism. Eighteen patients with masticatory muscle pain and sleep bruxism participated in this study. They were randomly allocated to either the splint group, who wore stabilisation splints during sleep (n = 9), or the control group (n = 9). Electromyographic activities of the masseter muscle during sleep were recorded at baseline, immediately after, and 1, 4, and 6 weeks after insertion of the stabilisation splint. Stabilisation splints had positive effects on both masticatory muscle pain and sleep bruxism, but effects on sleep bruxism were transient.
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 | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 03 | Month | 07 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 07 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 02 | Day |
Last modified on
| 2016 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017487
