UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of the tongue movement in oral function by using ultrasaound image appratus.
Title of the study (Brief title)	Analysis of tongue movement by ultrasaound
Region	Japan

Condition
Condition	malocclusion
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To establish the ultrasound imaging system for observing tongue movement.
Basic objectives2	Others
Basic objectives -Others	To investigate the effect s of tongue movement to apper the malocclusion by using ultrasound image apparatus.
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Position of tongue tip and tongue dorsum
Key secondary outcomes	Speed, the rate of accelation of tongue tip and tongue dorsum

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	Central registration

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	Request pronanciation or deglutition to the subjects and record the tongu movement by using ultrasound image appratus.
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	12 years-old <=
Age-upper limit	40 years-old >=
Gender	Male and Female
Key inclusion criteria	normal occlusion, malocclusion
Key exclusion criteria	No functional disorder in pronunciation or deglutition. No allergenic disorder in jelly coating tothe skin in using ultrasound probe.
Target sample size	50

Research contact person
Name of lead principal investigator	Shoichi Suzuki
Organization	Tokyo Mrdical and dental University
Division name	Department of Maxillofacial Orthognathics
Address	1-5-45 Yushima Bunkyou0-ku Tokyo
TEL	03-5803-5533
Email	s-suzuki.mort@tmd.ac.jp

Public contact
Name of contact person	Shoichi Suzuki
Organization	Tokyo Mrdical and dental University
Division name	Department of Maxillofacial Orthognathics
Address	1-5-45 Yushima Bunkyou0-ku Tokyo
TEL	03-5803-5533
Homepage URL
Email	s-suzuki.mort@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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付属病院

Other administrative information
Date of disclosure of the study information	2021 Year 04 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 03 Month 31 Day
Anticipated trial start date	2019 Year 04 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete	2022 Year 03 Month 31 Day
Date analysis concluded	2022 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2019 Year 02 Month 13 Day
Last modified on	2019 Year 02 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040865