UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026333 |
|---|---|
| Receipt number | R000030247 |
| Scientific Title | Study of relationship of internal derang ement of TMJ, maxillofacial morpholog y and stomatognathic function |
| Date of disclosure of the study information | 2017/02/28 |
| Last modified on | 2020/09/02 13:55:28 |
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Basic information
Public title
Study of relationship of internal derang ement of TMJ, maxillofacial morpholog y and stomatognathic function
Acronym
Relationship of malocclusion and TMJ disc displacement
Scientific Title
Study of relationship of internal derang ement of TMJ, maxillofacial morpholog y and stomatognathic function
Scientific Title:Acronym
Relationship of malocclusion and TMJ disc displacement
Region
| Japan |
Condition
Condition
malocclusion
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of relationship of malocclusion and TMJ disc displacement and difference of physiological and abnormal disc displacement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relation of anterior disc displacement and malocclusion
Relation of transversal disc displacement and malocclusion
Position of articular disc in patients
Position of articular disc in normal occlusion individuals
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient who diagnosed as an orthodontic treatment is necessary
no syndrome
no congenital or growth abnormality such as hypoplasia of the condylar process
no musculoskeletal disease such as muscular dystrophy and myasthenia gravis
no disease of nervous system such as neuropathic pain
no autoimmune disease such as rheumatoid arthritis
no previous history of trauma to the head or face
no occlusion with denture
clear MR image of TMJ
no joint effusions
no condylar fractures or neoplasms
Key exclusion criteria
contraindicating MR image acquisition
refusing to cooperation
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Teruko Yamamoto |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Orthodontics and Dentofacial Orthopedics
Zip code
Address
4-1,Seiryomachi, Aoba-ku, Sendai, 980-8574, Japan
TEL
022-717-8372
t-yamamo@m.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Teruko Yamamoto |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Orthodontics and Dentofacial Orthopedics
Zip code
Address
4-1,Seiryomachi, Aoba-ku, Sendai, 980-8574, Japan
TEL
022-717-8372
Homepage URL
t-yamamo@m.tohoku.ac.jp
Sponsor or person
Institute
Division of Orthodontics and Dentofacial Orthopedics, Tohoku University Graduate School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Division of Orthodontics and Dentofacial Orthopedics, Tohoku University Graduate School of Dentistry
Organization
Division
Category of Funding Organization
Other
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
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
| 2017 | Year | 02 | Month | 28 | 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
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
Terminated
Date of protocol fixation
| 2012 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The patients who visit to Tohoku Univ. Hosp. from 2008 include in experimental group.
The students or stuffs who have normal occlusion include in control group.
Management information
Registered date
| 2017 | Year | 02 | Month | 28 | Day |
Last modified on
| 2020 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030247
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
