UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036836 |
|---|---|
| Receipt number | R000041966 |
| Scientific Title | The efficacy of clear aligners |
| Date of disclosure of the study information | 2019/06/01 |
| Last modified on | 2019/05/23 22:48:18 |
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Basic information
Public title
The efficacy of clear aligners
Acronym
The efficacy of clear aligners
Scientific Title
The efficacy of clear aligners
Scientific Title:Acronym
The efficacy of clear aligners
Region
| Japan |
Condition
Condition
Class I or II malocclusion
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the scientific evidence related to the efficacy of clear aligner treatment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
treatment period
Key secondary outcomes
teeth alignment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
orthodontic treatment using computer-designed aligners
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with permanent dentition
Key exclusion criteria
patients with low compliance
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Chihiro |
| Middle name | |
| Last name | Tanikawa |
Organization
Osaka university Dental Hospital
Division name
Department of Orthodontics and Dentofacial Orthopedics
Zip code
565-0871
Address
1-8, Yamadaoka, Suita
TEL
06-6879-2958
ctanika@dent.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Chihiro |
| Middle name | |
| Last name | Tanikawa |
Organization
Osaka university Dental Hospital
Division name
Department of Orthodontics and Dentofacial Orthopedics
Zip code
565-0871
Address
1-8, Yamadaoka, Suita
TEL
06-6879-2958
Homepage URL
ctanika@dent.osaka-u.ac.jp
Sponsor or person
Institute
Osaka university
Institute
Department
Personal name
Funding Source
Organization
Align Technology Japan
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
the institutional review board and ethics committee of Osaka University Dental Hospital
Address
1-8, Yamadaoka, Suita
Tel
06-6879-5111
none@sample.com
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
大阪大学歯学部附属病院 矯正科
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 23 | Day |
Last modified on
| 2019 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041966
