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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name