UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019180
Receipt number R000022174
Scientific Title The intervention study on the effects of orthodontic tooth movement on somatosensory evoked magnetic fields in cerebral cortex
Date of disclosure of the study information 2015/10/05
Last modified on 2020/04/03 16:23:32

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Basic information

Public title

The intervention study on the effects of orthodontic tooth movement on somatosensory evoked magnetic fields in cerebral cortex

Acronym

The intervention study on the effects of orthodontic tooth movement on somatosensory evoked magnetic fields in cerebral cortex

Scientific Title

The intervention study on the effects of orthodontic tooth movement on somatosensory evoked magnetic fields in cerebral cortex

Scientific Title:Acronym

The intervention study on the effects of orthodontic tooth movement on somatosensory evoked magnetic fields in cerebral cortex

Region

Japan


Condition

Condition

Healthy

Classification by specialty

Dental medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purposes of this study are to characterize the pain associated with orthodontic tooth movement objectively by measuring SEF, to re-evaluate traditional treatments for the pain and to develop new approaches to pain relief.

Basic objectives2

Others

Basic objectives -Others

Objective evaluation of the pain caused by orthodontic tooth movement

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The MEG data

Key secondary outcomes

Questionnaires
- MRI check sheet
- dominant hand check sheet


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Elastic separaters are inserted between the teeth, both mesial and distal to the right maxillary/ mandibular first molars for 24 hours.

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

20 years-old <=

Age-upper limit

35 years-old >=

Gender

Male and Female

Key inclusion criteria

- A 20 to 35-year-old healthy adult who receives an enough explanation about the experiment and agrees to do it before the experiment
- Through the assessment of "MRI check sheet", a person whose result shows no risk of harm to attend the experiment
- A right-handed person through the assessment of "dominant hand check seat"

Key exclusion criteria

- A person who has received an orthodontic treatment
- A person who has a severe periodontal disease
- A person who has first molar(s) of which cusps covered by restorations like onlay or crown
- A person who has a nervous system disease

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Kaoru
Middle name
Last name Igarashi

Organization

Tohoku University Graduate School of Dentistry

Division name

Division of Craniofacial anomalies

Zip code

980-8575

Address

4-1, Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-8379

Email

kaoru.igarashi.a3@tohoku.ac.jp


Public contact

Name of contact person

1st name Eriya
Middle name
Last name Shimada

Organization

Tohoku University Graduate School of Dentistry

Division name

Division of Craniofacial anomalies

Zip code

980-8575

Address

4-1, Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-8277

Homepage URL


Email

eriya@dent.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University Graduate School of Dentistry

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

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

Research ethics committee, Tohoku University Graduate School of Dentistry

Address

4-1, Seiryo-machi, Aoba-ku, Sendai

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



Other administrative information

Date of disclosure of the study information

2015 Year 10 Month 05 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

33

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

No longer recruiting

Date of protocol fixation

2015 Year 03 Month 31 Day

Date of IRB

2015 Year 03 Month 31 Day

Anticipated trial start date

2015 Year 10 Month 19 Day

Last follow-up date

2021 Year 01 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

2015 Year 09 Month 30 Day

Last modified on

2020 Year 04 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022174


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name