UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032589 |
|---|---|
| Receipt number | R000037161 |
| Scientific Title | An international survey for relationship between stomatognathic function and morphology in ASEAN inhabitants |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2018/05/14 17:35:26 |
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Basic information
Public title
An international survey for relationship between stomatognathic function and morphology in ASEAN inhabitants
Acronym
An international comparative survey of stomatognathic functions
Scientific Title
An international survey for relationship between stomatognathic function and morphology in ASEAN inhabitants
Scientific Title:Acronym
An international comparative survey of stomatognathic functions
Region
| Japan |
Condition
Condition
healthy people
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The applicants from Thailand or Vietnam belonging to the Association of Southeast Asian Nations (ASEAN) with normal occlusion will be considered, and both their craniofacial morphology and stomatognathic function will be examined in order to obtain biological statistical data to become a reference.
Basic objectives2
Others
Basic objectives -Others
The specific goal of the present study is to analyze the correlation between the morphology and function of the stomatognathic region, comparing between the multi-ethnics in order to investigate the relationship between the morphology and function of the maxillofacial area.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
There are differences in maxillofacial morphology among Japanese, Thai, and Vietnamese healthy people.
Key secondary outcomes
There are differences in stomatognathic functions (especially activity pattern of occlusal muscles) among Japanese, Thai, and Vietnamese healthy people.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Single standard X-ray film of lateral and frontal head, and panoramic radiograph
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
30 subjects with normal occlusion, without history of previous orthodontic treatment, healthy male/female adults
Key exclusion criteria
People with orthodontic history, malocclusion, missing teeth, or periodontitis.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ono Takashi |
Organization
Tokyo Medical and Dental University Graduate School, Medical and Dental Sciences
Division name
Orthodontic Science
Zip code
Address
Yushima 1-5-45, Bunkyo-ku, Tokyo
TEL
03-5803-5526
t.ono.orts@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ishida Yuji |
Organization
Tokyo Medical and Dental University Graduate School, Medical and Dental Sciences
Division name
Orthodontic Science
Zip code
Address
Yushima 1-5-45, Bunkyo-ku, Tokyo
TEL
03-5803-5528
Homepage URL
2010nanani@gmail.com
Sponsor or person
Institute
Orthodontic Science
Institute
Department
Personal name
Funding Source
Organization
Orthodontic Science
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
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
東京医科歯科大学歯学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 06 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 14 | Day |
Last modified on
| 2018 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037161
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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