UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025148
Receipt number R000028918
Scientific Title Study on the volume of upper airway for orthodontic treatment patients
Date of disclosure of the study information 2018/04/01
Last modified on 2016/12/05 15:09:47

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Basic information

Public title

Study on the volume of upper airway for orthodontic treatment patients

Acronym

Study on upper airway volume of orthodontic patients

Scientific Title

Study on the volume of upper airway for orthodontic treatment patients

Scientific Title:Acronym

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

1st name
Middle name
Last name Hiroshi Kamioka

Organization

Graduate School of Medicine, Dentistry and pharmaceutical Science, Okayama University

Division name

Department of orthodontics

Zip code


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

1st name
Middle name
Last name Tomoki Kataoka

Organization

Graduate School of Medicine, Dentistry and pharmaceutical Science, Okayama University

Division name

Department of orthodontics

Zip code


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 or person

Institute

Okayama University

Institute

Department

Personal name



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)



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



Other administrative information

Date of disclosure of the study information

2018 Year 04 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

Preinitiation

Date of protocol fixation

2017 Year 03 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028918


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name