UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of factors of asymmetry in mouth corners
Acronym	Investigation of factors of asymmetry in mouth corners
Scientific Title	Investigation of factors of asymmetry in mouth corners
Scientific Title:Acronym	Investigation of factors of asymmetry in mouth corners
Region	Japan

Condition
Condition	none
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The cause of facial asymmetry, especially the left-right difference in the corners of the mouth, is thought to be due to the habit of chewing and the structure of the lower jaw. This time, we thought that the dominant hand (the person who holds the chopsticks) may be related to these factors. To evaluate facial symmetry in oral surgery patients. The primary endpoint is the contributing factor to the elevation of the corners of the mouth.
Basic objectives2	Others
Basic objectives -Others	None
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Factors that raise the corners of the mouth
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who have taken a panoramic X-ray, and patients who have given their voluntary consent after receiving sufficient explanations before participating in the research.
Key exclusion criteria	Patients who refused to participate in this study Other patients who are judged by the principal investigator to be unsuitable as research subjects
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Yuki Middle name Last name Sakamoto
Organization	Kansai Medical University Medical centre
Division name	Dentistry and Oral Surgery
Zip code	5708507
Address	10-15 Fumizono-cho Moriguchi-shi
TEL	0669939420
Email	s.yukioutdoor@gmail.com

Public contact
Name of contact person	1st name Yuki Middle name Last name Sakamoto
Organization	Kansai Medical University Medical centre
Division name	Dentistry and Oral Surgery
Zip code	5708507
Address	10-15 Fumizono-cho Moriguchi-shi
TEL	0669939420
Homepage URL
Email	s.yukioutdoor@gmail.com

Sponsor
Institute	Kansai Medical University
Institute
Department

Funding Source
Organization	Kansai Medical University
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	K
Address	10-15 Fumizono-chyo Moriguchi-shi
Tel	06699339421
Email	s.yukioutdoor@gmail.com

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

Other administrative information
Date of disclosure of the study information	2024 Year 01 Month 31 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	Preinitiation
Date of protocol fixation	2022 Year 10 Month 27 Day
Date of IRB
Anticipated trial start date	2023 Year 03 Month 31 Day
Last follow-up date	2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2022 Year 10 Month 27 Day
Last modified on	2022 Year 10 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056197