UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021803 |
|---|---|
| Receipt number | 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 | 2022/05/05 17:18:32 |
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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
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/
kitahara@dent.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
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
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
Terminated
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
| 2022 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025142
