UMIN-CTR Clinical Trial

Basic information
Public title	The association of perioral muscles and maxillofacial morphology, malocclusion
Acronym	The association of perioral muscles and maxillofacial morphology, malocclusion
Scientific Title	The association of perioral muscles and maxillofacial morphology, malocclusion
Scientific Title:Acronym	The association of perioral muscles and maxillofacial morphology, malocclusion
Region	Japan

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

Objectives
Narrative objectives1	research about effect of perioral muscles to maxillofacial morphology and malocclusion
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	lip closing force(before going in orthodontic treatment) maximum tongue pressure(before going in orthodontic treatment)
Key secondary outcomes	denture model(before going in orthodontic treatment) maximum bite force(before going in orthodontic treatment)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	normal occlusion group
Interventions/Control_2	patient group
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	6 years-old <=
Age-upper limit	50 years-old >=
Gender	Male and Female
Key inclusion criteria	Patient group: 270 patients of malocclusion treated orthodontics in Tokushima university hospital from 2020 July to 2025 March. Normal occlusion group: Among trust students performing a bedside teaching in this school student, staff and senior Pops, it is 30 individual normal occlusion people.
Key exclusion criteria	It is person with experience of the correction treatment in the past.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Horiuchi Middle name Last name Shinya
Organization	Tokushima university
Division name	Department of Orthodontics and dentofacial orthopedics, institute of biomedical science
Zip code	7708504
Address	3-18-15 Kuramoto, Tokushima 770-8503, Japan
TEL	0886337357
Email	horiu@tokushima-u.ac.jp

Public contact
Name of contact person	1st name Tanaka Middle name Last name Eiji
Organization	Tokushima university
Division name	Department of Orthodontics and dentofacial orthopedics, institute of biomedical science
Zip code	7708504
Address	3-18-15 Kuramoto, Tokushima 770-8503, Japan
TEL	0886337357
Homepage URL
Email	etanaka@tokushima-u.ac.jp

Sponsor
Institute	Tokushima university
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tokushima university
Address	2-50-1 kuramoto, Tokushima 770-8503, Japan
Tel	0886339294
Email	awachiken@tokushima-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

Other administrative information
Date of disclosure of the study information	2020 Year 07 Month 22 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	2020 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date	2020 Year 07 Month 22 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 07 Month 21 Day
Last modified on	2020 Year 07 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047026