UMIN-CTR Clinical Trial

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

malocclusion

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Conventional cephalometric, tooth model and faicial measurements analyses.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Nihon University School of Dentistry

Institute

Department

Personal name

Organization

Nihon University School of Dentistry

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

日本大学歯学部付属歯科病院

Date of disclosure of the study information

2020

Year

07

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

In total, 6 subjects are currently receiving the orthodontic treatment as of February 7th, 2024. Two of these patients are in the final phase of active treatment using the aligners and are scheduled to begin retention in the next few months. Another three patients have completed evaluation of their treatment effects and are currently on retention period. Remaining one who had been under treatment with fixed appliance due to poor cooperation of wearing the aligners was shifted to orthodontic treatment with the aligners again.

Registered date

2020

Year

02

Month

05

Day

Last modified on

2024

Year

02

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043556