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
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
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
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
