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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000024966
Receipt No. R000028687
Scientific Title Development of the new rehabilitation method for jaw deformity patients.
Date of disclosure of the study information 2016/11/23
Last modified on 2016/11/23

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Basic information
Public title Development of the new rehabilitation method for jaw deformity patients.
Acronym Development of the new rehabilitation method.
Scientific Title Development of the new rehabilitation method for jaw deformity patients.
Scientific Title:Acronym Development of the new rehabilitation method.
Region
Japan

Condition
Condition Jaw deformity
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Development of the new rehabilitation method for jaw deformity patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Activity index
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Training group
Interventions/Control_2 Non-training group
Interventions/Control_3 Normal occlusion group
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
10 years-old <=
Age-upper limit
39 years-old >
Gender Male and Female
Key inclusion criteria Training group : 50 patients (forward intervention study) who treat the cause of the diagnosis of the chin transformation symptom, surgical correction in Tokushima university hospital by March, 2020 from current study approval day.

Non-training group : Orthodontic clinic patient 50 (backward investigation) surgical from January, 2011 to August, 2016 in Tokushima univercity hospital of the diagnosis of the chin transformation symptom whom I treated.

Normal occlusion group : Among trust students performing a bedside teaching in this school student, staff and senior Popes, it is 50 individual normal occlusion people.
Key exclusion criteria Training group, non-training group
1 Chin transformation symptom patient due to inborn character abnormality
2 The patient who has a symptom to temporomandibular joint

Normal occlusion group
1 It is a person with the disharmony for the relations between the chin
2 Person having the prosthesis that cuspid, molar tooth relations coat crowding, tooth missing, cusp in other than I grade and top and bottom dentition
3 It is a person with the experience of the correction treatment in the past
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiji Tanaka
Organization Tokushima univercity
Division name Department of Orthodontics and dentofacial orthopedics, institute of biomedical science
Zip code
Address 2-50-1 Kuramoto, Tokushima 770-8503, Japan
TEL 088-631-3111
Email eiji46y@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Misako Tano
Organization Tokushima univercity
Division name Accounting and Procurement Division
Zip code
Address 2-50-1 kuramoto, Tokushima 770-8503, Japan
TEL 088-631-3111
Homepage URL
Email tano.misako@tokushima-u.ac.jp

Sponsor
Institute Tokushima univercity
Institute
Department

Funding Source
Organization Tokushima univercity
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
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
2016 Year 11 Month 23 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
Date of protocol fixation
2016 Year 08 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 30 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 11 Month 23 Day
Last modified on
2016 Year 11 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028687

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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