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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036836
Receipt No. R000041966
Scientific Title The efficacy of clear aligners
Date of disclosure of the study information 2019/06/01
Last modified on 2019/05/23

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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
Email 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
Email ctanika@dent.osaka-u.ac.jp

Sponsor
Institute Osaka university
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041966

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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