UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041183 |
|---|---|
| Receipt number | R000047026 |
| Scientific Title | The association of perioral muscles and maxillofacial morphology, malocclusion |
| Date of disclosure of the study information | 2020/07/22 |
| Last modified on | 2020/07/21 20:15:07 |
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Basic information
Public title
The association of perioral muscles and maxillofacial morphology, malocclusion
Acronym
The association of perioral muscles and maxillofacial morphology, malocclusion
Scientific Title
The association of perioral muscles and maxillofacial morphology, malocclusion
Scientific Title:Acronym
The association of perioral muscles and maxillofacial morphology, malocclusion
Region
| Japan |
Condition
Condition
malocclusion
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
research about effect of perioral muscles to maxillofacial morphology and malocclusion
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
lip closing force(before going in orthodontic treatment)
maximum tongue pressure(before going in orthodontic treatment)
Key secondary outcomes
denture model(before going in orthodontic treatment)
maximum bite force(before going in orthodontic treatment)
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
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
normal occlusion group
Interventions/Control_2
patient group
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
| 6 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient group: 270 patients of malocclusion treated orthodontics in Tokushima university hospital from 2020 July to 2025 March.
Normal occlusion group: Among trust students performing a bedside teaching in this school student, staff and senior Pops, it is 30 individual normal occlusion people.
Key exclusion criteria
It is person with experience of the correction treatment in the past.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Horiuchi |
| Middle name | |
| Last name | Shinya |
Organization
Tokushima university
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
0886337357
horiu@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Tanaka |
| Middle name | |
| Last name | Eiji |
Organization
Tokushima university
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
0886337357
Homepage URL
etanaka@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima university
Institute
Department
Personal name
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 university
Address
2-50-1 kuramoto, Tokushima 770-8503, Japan
Tel
0886339294
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
| 2020 | Year | 07 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2025 | 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
| 2020 | Year | 07 | Month | 21 | Day |
Last modified on
| 2020 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047026
| 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 |
