UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027564
Receipt number R000031601
Scientific Title The effect of orthognathic treatment to the temporomandibular joint.
Date of disclosure of the study information 2017/05/31
Last modified on 2019/12/02 09:30:38

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The effect of orthognathic treatment to the temporomandibular joint.

Acronym

The effect of orthognathic treatment to the temporomandibular joint.

Scientific Title

The effect of orthognathic treatment to the temporomandibular joint.

Scientific Title:Acronym

The effect of orthognathic treatment to the temporomandibular joint.

Region

Japan


Condition

Condition

jaw deformity

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To crsalify the influence of orthognathic treatment to the temporomandibular joint.

Basic objectives2

Others

Basic objectives -Others

Change of articular disc of temporomandibular joint after orthognathic treatment.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Symptoms od temporomandibular joint at setting the retainer.

Key secondary outcomes

1. change of disc position
2. change of morphology of chondylar head
3. change of jaw mobility


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

16 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

jaw deformity

Key exclusion criteria

creft
systematic disease
pregnancy

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Seigo
Middle name
Last name Ohba

Organization

Nagasaki University

Division name

Division of Regenerative Oral Surgery

Zip code

852-8588

Address

1-7-1 Sakamoto, Nagasaki

TEL

095-819-7704

Email

sohba@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name Seigo
Middle name
Last name Ohba

Organization

Nagasaki University

Division name

Division of Regenerative Oral Surgery

Zip code

852-8588

Address

1-7-1 Sakamoto, Nagasaki

TEL

095-819-7704

Homepage URL


Email

sohba@nagasaki-u.ac.jp


Sponsor or person

Institute

Nagasaki University

Institute

Department

Personal name



Funding Source

Organization

Nagasaki 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

Nagasaki University

Address

1-7-1 Sakamoto, Nagasaki

Tel

095-819-7704

Email

sohba@nagasaki-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

2017 Year 05 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

20

Results

terminated due to re-concerning.

Results date posted

2019 Year 12 Month 02 Day

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

Terminated

Date of protocol fixation

2015 Year 10 Month 15 Day

Date of IRB

2015 Year 10 Month 15 Day

Anticipated trial start date

2015 Year 10 Month 15 Day

Last follow-up date

2019 Year 11 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Terminated due to re-assessment.


Management information

Registered date

2017 Year 05 Month 31 Day

Last modified on

2019 Year 12 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031601


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name