UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the volume of upper airway for orthodontic treatment patients
Title of the study (Brief title)	Study on upper airway volume of orthodontic patients
Region	Japan

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

Objectives
Narrative objectives1	This study demonstrates the relationship between the volume of upper airway and the movement of tooth and jaw treated with orthodontic treatment.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	the volume of upper airway and thecephalometric variables before, under and after orthodontic treatment
Key secondary outcomes	the area of upper airway, the dentition and malocclusion before, under and after treatment

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
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	Device,equipment
Interventions/Control_1	Imaging of MRI (before, under and after treatment, and examination of PSG (before orthognathic surgery)
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with malocclusion 2) Outpatients visiting Department of Orthodontics, Okayama University Hospital 3) More than 12 years old patients with all parmanent teeth 4) Underage patinets with a consent of their parent, person in parental authority, spouse, adult brother and sister, grandparent, relative, guardian, and curator
Key exclusion criteria	1) Patients without malocclusion 2) Patients who has difficulty in imaging of MRI 3) Patients who has difficulty in X-rays photography 4) Patients who has difficulty in PSG examination 5) Patinets with syndrome 6) Patients who will be able to continue the treatment until finishing the treatment 7) Inappropriate patients judged by principal investigator or members of this study
Target sample size	100

Research contact person
Name of lead principal investigator	Hiroshi Kamioka
Organization	Graduate School of Medicine, Dentistry and pharmaceutical Science, Okayama University
Division name	Department of orthodontics
Address	2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama
TEL	086-235-6692
Email	kamioka@md.okayama-u.ac.jp

Public contact
Name of contact person	Tomoki Kataoka
Organization	Graduate School of Medicine, Dentistry and pharmaceutical Science, Okayama University
Division name	Department of orthodontics
Address	2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama
TEL	086-235-6692
Homepage URL
Email	tkataoka@md.okayama-u.ac.jp

Sponsor
Institute	Okayama University
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
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

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 03 Month 01 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2016 Year 12 Month 05 Day
Last modified on	2016 Year 12 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028918