UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051828 |
|---|---|
| Receipt number | R000059147 |
| Scientific Title | Functional changes in patients with malocclusion undergoing orthodontic treatment: A multicenter collaborative study |
| Date of disclosure of the study information | 2023/08/04 |
| Last modified on | 2024/02/05 13:39:27 |
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Basic information
Public title
Functional changes in patients with malocclusion undergoing orthodontic treatment: A multicenter collaborative study
Acronym
Functional changes in patients with malocclusion undergoing orthodontic treatment: A multicenter collaborative study
Scientific Title
Functional changes in patients with malocclusion undergoing orthodontic treatment: A multicenter collaborative study
Scientific Title:Acronym
Functional changes in patients with malocclusion undergoing orthodontic treatment: A multicenter collaborative study
Region
| Japan |
Condition
Condition
malocclusion
cleft lip and palate
facial deformities
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the functional changes before and after orthodontic treatment for patients with malocclusion
Basic objectives2
Others
Basic objectives -Others
To clarify the functional changes before and after orthodontic treatment for patients with malocclusion
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stomatognathic system
Hand grip strength
Psychological assessments
Digestive symptoms
Temporomandibular joint disorders
Sleep disorder
Key secondary outcomes
Maxillofacial morphology
Soft tissue
Base
Study type
Observational
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
informed consent
Key exclusion criteria
Syndrome excepting cleft lip and palate
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | Shouichi |
| Middle name | |
| Last name | Miyawaki |
Organization
kagoshima University hospital
Division name
Department of Orthodontics
Zip code
890-8544
Address
8-35-1, Sakuragaoka, Kagoshima, Japan
TEL
099-275-6252
miyawaki@dent.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | shoko |
| Middle name | |
| Last name | nakagawa |
Organization
Kagoshima university hospital
Division name
Department of Orthodontics
Zip code
890-8544
Address
8-35-1, Sakuragaoka, Kagoshima, Japan
TEL
0992756252
Homepage URL
miyawaki@dent.kagoshima-u.ac.jp
Sponsor or person
Institute
Department of Orthodontics and Dentofacial Orthopedics, Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
Specific donations for the academic research project commemorating the 100th anniversary of the Japanese Orthodontic Society
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
Ethics Committee for Epidemiological Research, Sakuragaoka Area, Kagoshima University
Address
8-35-1, Sakuragaoka, Kagoshima, Japan
Tel
0992756624
crmc@m2.kufm.kagoshima-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
| 2023 | Year | 08 | Month | 04 | 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
100
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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A multicenter collaborative study
Management information
Registered date
| 2023 | Year | 08 | Month | 04 | Day |
Last modified on
| 2024 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059147
| 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 |
