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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021803
Receipt No. R000025142
Scientific Title Molecular imaging of energy metabolism of masticatory muscle in the patients with skeletal Class III jaw deformity in Japanese observed by mfMRI and 31P-MRS
Date of disclosure of the study information 2016/04/06
Last modified on 2019/04/09

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Basic information
Public title Molecular imaging of energy metabolism of masticatory muscle in the patients with skeletal Class III jaw deformity in Japanese observed by mfMRI and 31P-MRS
Acronym Molecular imaging of energy metabolism of masticatory muscle in skeletal Class III patients
Scientific Title Molecular imaging of energy metabolism of masticatory muscle in the patients with skeletal Class III jaw deformity in Japanese observed by mfMRI and 31P-MRS
Scientific Title:Acronym Molecular imaging of energy metabolism of masticatory muscle in skeletal Class III patients
Region
Japan

Condition
Condition Skeletal Class III jaw deformity patient and healthy volunteer
Classification by specialty
Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigate the energy metabolism of masticatory muscles in skeletal Class III jaw deformity
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Signal intensity of the phosphocreatine (PCr)
Key secondary outcomes Signal intensity of the inorganic phosphate (Pi)
pH
T2 relaxation time

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 clenching at 30% maximum voluntary contraction in the patients with skeletal Class III jaw deformity and the healthy volunteers
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The skeletal Class III jaw deformity patients and healthy volunteers of twenty years old and over participated in this study
Key exclusion criteria 1)general MRI examination contraindication cases
(2)symptoms of temporomandibular joint or jaw muscle disorders
(3) The subjects judged to be inappropriate by principal investigator
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Ichiro
Middle name
Last name Takahashi
Organization Faculty of Dental Science, Kyushu University
Division name the Section of Orthodontics, Division of Oral Health, Growth & Development
Zip code 812-8582
Address 3-1-1, Maidashi, Higashi-ku Fukuoka, 812-8582, Japan
TEL 092-642-6462
Email takahashi@dent.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Toru
Middle name
Last name Kitahara
Organization Faculty of Dental Science, Kyushu University
Division name he Section of Orthodontics, Division of Oral Health, Growth & Development
Zip code 812-8582
Address 3-1-1, Maidashi, Higashi-ku Fukuoka, 812-8582, Japan
TEL 092-642-6462
Homepage URL http://www.ortho.dent.kyushu-u.ac.jp/
Email kitahara@dent.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Hospital
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Section of Image Diagnosis, Department of Diagnostics and General Care, Fukuoka Dental College
Name of secondary funder(s)

IRB Contact (For public release)
Organization Center for Clinical and Translational Research(CCTR) of Kyushu University Hospital
Address 3-1-1, Maidashi, Higashi-ku Fukuoka, 812-8582, Japan
Tel 092-642-5774
Email tr-info@med.kyushu-u.ac.jp

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 福岡歯科大学医科歯科総合病院(福岡県) Fukuoka Dental college Medical and Dental Hospital

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 06 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 42
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 No longer recruiting
Date of protocol fixation
2016 Year 04 Month 06 Day
Date of IRB
2016 Year 06 Month 23 Day
Anticipated trial start date
2016 Year 08 Month 03 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We reported of the course on the way, In eighteen patients with mandibular protrusion and eighteen healthy volunteers, we evaluated the T2 relaxation time in the MR T2-weighted images and chemical shifts in the 31P-MRS.

Management information
Registered date
2016 Year 04 Month 06 Day
Last modified on
2019 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025142

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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