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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032452
Receipt No. R000037007
Scientific Title Establishment of new rehabilitation for jaw deformity patients using masticatory training food.
Date of disclosure of the study information 2018/05/02
Last modified on 2020/11/02

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Basic information
Public title Establishment of new rehabilitation for jaw deformity patients using masticatory training food.
Acronym Establishment of new rehabilitation using masticatory training food.
Scientific Title Establishment of new rehabilitation for jaw deformity patients using masticatory training food.
Scientific Title:Acronym Establishment of new rehabilitation using masticatory training food.
Region
Japan

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

Objectives
Narrative objectives1 Establishment of new rehabilitation using masticatory training food.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Activity Index
Key secondary outcomes Asymmetry Index of muscle activity
Error Index
Maximal occlusal force
Survey

Base
Study type Interventional

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

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Early Training group
from current study approval day to March, 2023
Interventions/Control_2 Late Training group
from April, 2016 to March, 2023
Interventions/Control_3 Non-Training group
from January, 2011 to February, 2018
Interventions/Control_4 Normal occlusion group
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
17 years-old <=
Age-upper limit
40 years-old >=
Gender Male and Female
Key inclusion criteria Early Training group : 35 patients of jaw deformities (forward in tervention study) treated surgical orthognathic in Tokushima university hospital from current study approval day to March, 2023.
Late Training group : 35 patients of jaw deformities (backward investigation) treated surgical orthognathic and masticatory exercise using chewing gum from April, 2016 to March, 2023 in Tokushima univercity hospital of the diagnosis of jaw deformities.
Non-training group : 35 patients of jaw deformities (forward in tervention study) treated surgical orthognathic in Tokushima university hospital from January, 2011 to February, 2018.
Normal occlusion group : Among trust students performing a bedside teaching in this school student, staff and senior Popes, it is 35 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.
3 The patient who has a symptom to Hyposalivation.
4 The patient who has a symptom to Swallowing dysfunction.
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.
4 The patient who has a symptom to Hyposalivation.
5 The patient who has a symptom to Swallowing dysfunction.
Target sample size 140

Research contact person
Name of lead principal investigator
1st name Horiuchi
Middle name
Last name Shinya
Organization Tokushima univercity
Division name Department of Orthodontics and dentofacial orthopedics, institute of biomedical science
Zip code 7708504
Address 3-18-15 Kuramoto, Tokushima 770-8503, Japan
TEL 088-633-7357
Email horiu@tokushima-u.ac.jp

Public contact
Name of contact person
1st name Tanaka
Middle name
Last name Eiji
Organization Tokushima univercity
Division name Department of Orthodontics and dentofacial orthopedics, institute of biomedical science
Zip code 7708504
Address 3-18-15 Kuramoto, Tokushima 770-8503, Japan
TEL 088-633-7357
Homepage URL
Email etanaka@tokushima-u.ac.jp

Sponsor
Institute Tokushima univercity
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokushima univercity
Address 2-50-1 kuramoto, Tokushima 770-8503, Japan
Tel 088-633-9294
Email awachiken@tokushima-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
2018 Year 05 Month 02 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
2018 Year 04 Month 09 Day
Date of IRB
2018 Year 08 Month 07 Day
Anticipated trial start date
2018 Year 08 Month 07 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 02 Day
Last modified on
2020 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037007

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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