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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000026333
Receipt No. 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

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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
Email 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
Email t-yamamo@m.tohoku.ac.jp

Sponsor
Institute Division of Orthodontics and Dentofacial Orthopedics, Tohoku University Graduate School of Dentistry
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030247

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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