UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022174