UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021832 |
|---|---|
| Receipt number | 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 | 2020/06/16 13:06:01 |
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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
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
cem17150@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2009 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2009 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 30 | Day |
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
| 2020 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025171
