UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017383
Receipt number R000020171
Scientific Title A clinical study of orthodontic miniscrew.
Date of disclosure of the study information 2015/05/06
Last modified on 2015/05/01 19:45:59

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Basic information

Public title

A clinical study of orthodontic miniscrew.

Acronym

A clinical study of orthodontic miniscrew.

Scientific Title

A clinical study of orthodontic miniscrew.

Scientific Title:Acronym

A clinical study of orthodontic miniscrew.

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 orthodontic miniscrew.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Quality of bone and teeth around the screw.
Evaluation about pain.
Evaluation about inflammation.
Change of craniofacial morphology and stomatognathic function.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are 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

Install of the orthodontic miniscrew.

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


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 inflamed diseases,tumors, and cysts of the jaw.

Target sample size

750


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Teruko Yamamoto

Organization

Tohoku University GraduateSchool of Dentistry

Division name

Division of Orthodontics and DentofacialOrthopedics

Zip code


Address

4-1, Seiryomachi, Aoba-ku, Sendai, 980-8575, Japan

TEL

022-717-8372

Email

t-yamamo@m.tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Teruko Yamamoto

Organization

Tohoku University Graduate School of Dentistry

Division name

Division of Orthodontics and Dentofacial Orthopedics

Zip code


Address

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

TEL

022-717-8372

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


Address


Tel


Email



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



Other administrative information

Date of disclosure of the study information

2015 Year 05 Month 06 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

Main results already published

Date of protocol fixation

2008 Year 01 Month 07 Day

Date of IRB


Anticipated trial start date

2008 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 05 Month 01 Day

Last modified on

2015 Year 05 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020171


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name