UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000030247