UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027573
Receipt number R000031612
Scientific Title soft tissue change after orthognathic treatment
Date of disclosure of the study information 2017/05/31
Last modified on 2023/06/22 18:38:23

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Basic information

Public title

soft tissue change after orthognathic treatment

Acronym

soft tissue change after orthognathic treatment

Scientific Title

soft tissue change after orthognathic treatment

Scientific Title:Acronym

soft tissue change after orthognathic treatment

Region

Japan


Condition

Condition

patient with jae deformity

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to assess soft tissuie change after orthognathic surgical treatment.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the relashonship between doft and hard tissues 1 year after orthognathicsurgery.

Key secondary outcomes

the change of the morphology of nasal apature


Base

Study type

Others,meta-analysis etc


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

patienmt with jaw deformity

Key exclusion criteria

1. creft
2. systematic disease
3. pregnancy

Target sample size

50


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 Univerity

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 Uversity

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


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

No longer recruiting

Date of protocol fixation

2016 Year 04 Month 26 Day

Date of IRB

2016 Year 04 Month 26 Day

Anticipated trial start date

2016 Year 04 Month 26 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

now proceeding.
Fifty patients have been included in this study.
Now assessment.


Management information

Registered date

2017 Year 05 Month 31 Day

Last modified on

2023 Year 06 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031612


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name