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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032589
Receipt No. 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

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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
Email 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
Email 2010nanani@gmail.com

Sponsor
Institute Orthodontic Science
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037161

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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