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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039394
Receipt No. R000043556
Scientific Title Development of new orthodontic treatment methods using the clear aligners with orthodontic anchoring screw.
Date of disclosure of the study information 2020/07/01
Last modified on 2020/02/05

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Basic information
Public title Development of new orthodontic treatment methods using the clear aligners with orthodontic anchoring screw.
Acronym Development of new treatment with aligners and orthodontic screw.
Scientific Title Development of new orthodontic treatment methods using the clear aligners with orthodontic anchoring screw.
Scientific Title:Acronym Development of new treatment with aligners and orthodontic screw.
Region
Japan

Condition
Condition malocclusion
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Aligners and orthodontic anchoring screws have often been used in orthodontic practice. The aligners have advantages such as superior to aestheticism, removable appliance and high cleanability. On the other hand, the aligner has disadvantage such as difficulty in use for severe cases requires distal or intrusive tooth movement and extraction treatment with anchoring screws.
This study aims to establish a new treatment method that provides the distal and intrusive movements of anterior segment or entire dental arch in parallel with alignment stages.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Conventional cephalometric, tooth model and faicial measurements analyses.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 During the period of 1.5-3 years required for orthodontic active treatment, monthly treatments with the aligners and the orthodontic anchoring screw for malocclusions. The amount of the aligners in each treatment would be 10-20 sets.
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
60 years-old >
Gender Male and Female
Key inclusion criteria Patients with malocclusion that needs the premolar extraction or distal or intrusive movement for orthodontic treatment.
Key exclusion criteria In case the agreement in the purpose of this study is not provided.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name Mitsuru
Middle name
Last name Motoyoshi
Organization Nihon University School of Dentistry
Division name Department of Orthodontics
Zip code 101-8310
Address 1-8-13, Kanda-surugadai, Chiyoda-ku, Tokyo, 1018310, JAPAN
TEL 03-3219-8105
Email motoyoshi.mitsuru@nihon-u.ac.jp

Public contact
Name of contact person
1st name Mitsuru
Middle name
Last name Motoyoshi
Organization Nihon University School of Dentistry
Division name Department of Orthodontics
Zip code 101-8310
Address 1-8-13, Kanda-surugadai, Chiyoda-ku, Tokyo, 1018310, JAPAN
TEL 03-3219-8105
Homepage URL
Email motoyoshi.mitsuru@nihon-u.ac.jp

Sponsor
Institute Nihon University School of Dentistry
Institute
Department

Funding Source
Organization Nihon University School of Dentistry
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 Ethical Committee of Nihon University School of Dentistry
Address 1-8-13, Kanda-surugadai, Chiyoda-ku, Tokyo, 1018310, JAPAN
Tel 03-3219-8020
Email de.hospital@nihon-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 日本大学歯学部付属歯科病院

Other administrative information
Date of disclosure of the study information
2020 Year 07 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 Open public recruiting
Date of protocol fixation
2020 Year 02 Month 05 Day
Date of IRB
2019 Year 09 Month 19 Day
Anticipated trial start date
2020 Year 02 Month 05 Day
Last follow-up date
2024 Year 12 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 02 Month 05 Day
Last modified on
2020 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043556

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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