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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015032
Receipt No. 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

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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
Email 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
Email tsuki@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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017487

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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