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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019180
Receipt No. 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 2019/04/03

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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
Institute Tohoku University Graduate School of Dentistry
Institute
Department

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
2020 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
2019 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.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


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