UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049085 |
|---|---|
| Receipt number | R000054470 |
| Scientific Title | Exploratory research on the effectiveness of orthodontic treatment using a mouthpiece-type custom-made orthodontic device for malocclusion |
| Date of disclosure of the study information | 2022/09/30 |
| Last modified on | 2024/04/03 14:26:51 |
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Basic information
Public title
Exploratory research on the effectiveness of orthodontic treatment using a mouthpiece-type custom-made orthodontic device for malocclusion
Acronym
Effectiveness of mouthpiece type orthodontic appliance
Scientific Title
Exploratory research on the effectiveness of orthodontic treatment using a mouthpiece-type custom-made orthodontic device for malocclusion
Scientific Title:Acronym
Effectiveness of mouthpiece type orthodontic appliance
Region
| Japan |
Condition
Condition
malocculusion
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to verify whether the ideal occlusion is established by orthodontic treatment using a clear aligner therapy and to clarify its effectiveness.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of occlusal status: At the final stage of treatment, the occlusal status after dynamic treatment with a mouthpiece-type orthodontic appliance will be assessed using the American Board of Orthodontics (ABO) objective review system (OGS).
Key secondary outcomes
Usage time evaluation
Assessment of pain during treatment
X-ray evaluation
Assess temporomandibular joint
Assess temporomandibular joint
Evaluation of periodontal condition
Evaluation of caries
Evaluation of duration of treatment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
After closing the tooth extraction space using a multi-bracket device, fine adjustment is performed using a clear aligner orthodontic device.
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
| 16 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Aged 16 or over and under 40 at the time of obtaining consent
2. Patients who have extracted maxillary and mandibular premolars (regardless of the difference between the first and second premolars) and are undergoing orthodontic treatment with a multi-bracket appliance
3. Patients who can see a doctor once a month
4. Those who can obtain written consent from the person or a legally acceptable person regarding participation in this research
Key exclusion criteria
1. Persons with a significant skeletal discrepancy
2. Subjects with congenital anomalies such as cleft lip and palate
3. Subjects with systemic diseases or medications that interfere with treatment
4. Persons with less than 24 teeth, excluding teeth extracted for convenience, wisdom teeth, and supernumerary teeth
5. Subjects who have ankylosis (osseous adhesion) due to trauma
6. Subjects with severe periodontal disease
7. Subjects who take painkillers frequently (more than once a day)
8. Others who are deemed inappropriate by the principal investigator or co-investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Tanimoto |
Organization
Hiroshima University Graduate School
Division name
Biomedical and Health Sciences
Zip code
7348553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City
TEL
082-257-5555
tkotaro@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Kunimatsu |
Organization
Hiroshima University
Division name
Orthodontics
Zip code
7348553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City
TEL
0822575686
Homepage URL
ryoukunimatu@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
ASO International Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University Clinical Research Review Committee Secretariat
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City
Tel
0822571947
iryo-seisaku@office.hiroshima-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
広島大学病院(広島)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 30 | 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
| 2022 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2027 | 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
| 2022 | Year | 09 | Month | 30 | Day |
Last modified on
| 2024 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054470
| Research Plan | |
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| 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 |
