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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027573
Receipt No. R000031612
Scientific Title soft tissue change after orthognathic treatment
Date of disclosure of the study information 2017/05/31
Last modified on 2019/06/02

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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
Institute Nagasaki University
Institute
Department

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 Open public 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.
Almost forty patients has been included in this study.

Management information
Registered date
2017 Year 05 Month 31 Day
Last modified on
2019 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.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


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