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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021832
Receipt No. R000025171
Scientific Title Is occlusal splint therapy anatomically effective for TMJ symptoms?
Date of disclosure of the study information 2016/04/07
Last modified on 2018/06/14

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Basic information
Public title Is occlusal splint therapy anatomically effective for TMJ symptoms?
Acronym The influence that an occlusal splint brings to temporomandibular joint
Scientific Title Is occlusal splint therapy anatomically effective for TMJ symptoms?
Scientific Title:Acronym The influence that an occlusal splint brings to temporomandibular joint
Region
Japan

Condition
Condition Temporomandibular disorder
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the relationship between displacement of the condyle/disc due to occlusal splint insertion and the changes in pain/discomfort of temporomandibular joint (TMJ) with splint-treatment, and to clarify the relationships between the prognosis of temporomandibular disorders and TMJ MRI findings at the start of splint therapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Make the mechanism of action of the splint therapy adapted to in temporomandibular disorder treatment
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The inclusion criteria are: 1) the patient had masticatory myalgia caused by clenching and/or bruxism; 2) the patient have arthralgia of the TMJ caused by clenching and/or bruxism that aggravated the bony changes on the condylar surface; and 3) the patient have chronic clicking and/or episodic locking of the TMJ, with suspected clenching and/or bruxism.
Key exclusion criteria The exclusion criteria were that it was not obtained consent to study entry.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiromitsu Kishimoto
Organization Hyogo College of Medicine
Division name Department of Dentistry and Oral Surgery
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL 0798456677
Email om-hyogo@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoko Hasegawa
Organization Hyogo College of Medicine
Division name Department of Dentistry and Oral Surgery
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL 0798456677
Homepage URL
Email cem17150@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Science and Culture of Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 H21-E4
Org. issuing International ID_1 Osaka University School of Dentistry
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 07 Day

Related information
URL releasing protocol
Publication of results Partially 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 Enrolling by invitation
Date of protocol fixation
2009 Year 01 Month 30 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
2018 Year 03 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information We analyzed the experimental data and made paper writing.

Management information
Registered date
2016 Year 04 Month 07 Day
Last modified on
2018 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025171

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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