UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039394 |
|---|---|
| Receipt number | 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 | 2024/08/09 11:12:28 |
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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
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
motoyoshi.mitsuru@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Dentistry
Institute
Department
Personal name
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
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
6
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
Completed
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 | 06 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In total, 6 subjects are currently receiving the orthodontic treatment as of August 9th, 2024. All patients have completed evaluation of their treatment effects and are currently on retention period. Since the initial target number of subjects was reached and case analysis was completed, recruitment of subjects and the study were terminated.
Management information
Registered date
| 2020 | Year | 02 | Month | 05 | Day |
Last modified on
| 2024 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043556
