UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013722
Receipt number R000016021
Scientific Title The effect of vibration on acceleration of orthodontic tooth movement.
Date of disclosure of the study information 2014/04/18
Last modified on 2020/10/21 15:08:45

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The effect of vibration on acceleration of orthodontic tooth movement.

Acronym

The acceleration of orthodontic tooth movement

Scientific Title

The effect of vibration on acceleration of orthodontic tooth movement.

Scientific Title:Acronym

The acceleration of orthodontic tooth movement

Region

Japan


Condition

Condition

Malocclusion

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To reveal the effect of vibration on acceleration of orthodontic tooth movement

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II


Assessment

Primary outcomes

Tooth movement
Velocity of tooth movement
Root resorption
Evaluation about pain

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Vibrations are applied

Interventions/Control_2

Tooth movement

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The patients diagnosed as an orthodontic treatment is necessary.

Key exclusion criteria

The patient who has a teeth in the middle of the formation.
The patient who has inflamed diseases,tumors, and cysts of the jaw.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Teruko
Middle name
Last name Yamamoto

Organization

Tohoku University Graduate School of Dentistry

Division name

Division of Orthodontics and Dentofacial Orthopedics

Zip code

980-8575

Address

4-1, Seiryomachi, Aoba-ku, Sendai, 980-8574, Japan

TEL

0227178374

Email

t-yamamo@m.tohoku.ac.jp


Public contact

Name of contact person

1st name Teruko
Middle name
Last name Yamamoto

Organization

Tohoku University Graduate School of Dentistry

Division name

Division of Orthodontics and Dentofacial Orthopedics

Zip code

980-8575

Address

4-1, Seiryomachi, Aoba-ku, Sendai, 980-8574, Japan

TEL

0227178374

Homepage URL


Email

t-yamamo@m.tohoku.ac.jp


Sponsor or person

Institute

Division of Orthodontics and Dentofacial Orthopedics, Tohoku University Graduate School of Dentistry

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Division of Orthodontics and Dentofacial Orthopedics, Tohoku University Graduate School of Dentistry

Address

4-1, Seiryomachi, Aoba-ku, Sendai, 980-8574, Japan

Tel

022-717-8244

Email

den-syom@bureau.tohoku.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

東北大学病院(宮城県)


Other administrative information

Date of disclosure of the study information

2014 Year 04 Month 18 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

25

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

2012 Year 08 Month 15 Day

Date of IRB

2012 Year 04 Month 20 Day

Anticipated trial start date

2012 Year 09 Month 03 Day

Last follow-up date

2018 Year 09 Month 10 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 04 Month 15 Day

Last modified on

2020 Year 10 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016021


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name