UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024966 |
|---|---|
| Receipt number | 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 15:39:34 |
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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
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
tano.misako@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima univercity
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028687
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
