UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013722 |
|---|---|
| Receipt number | R000016021 |
| Scientific Title | The effect of vibration on acceleration of orthodontic tooth movement. |
| Date of disclosure of the study information | 2014/04/18 |
| Last modified on | 2020/10/21 15:08:45 |
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Basic information
Public title
The effect of vibration on acceleration of orthodontic tooth movement.
Acronym
The acceleration of orthodontic tooth movement
Scientific Title
The effect of vibration on acceleration of orthodontic tooth movement.
Scientific Title:Acronym
The acceleration of orthodontic tooth movement
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 vibration on acceleration of orthodontic tooth movement
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Tooth movement
Velocity of tooth movement
Root resorption
Evaluation about pain
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Vibrations are applied
Interventions/Control_2
Tooth movement
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 a teeth in the middle of the formation.
The patient who has inflamed diseases,tumors, and cysts of the jaw.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Teruko |
| Middle name | |
| Last name | Yamamoto |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Orthodontics and Dentofacial Orthopedics
Zip code
980-8575
Address
4-1, Seiryomachi, Aoba-ku, Sendai, 980-8574, Japan
TEL
0227178374
t-yamamo@m.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Teruko |
| Middle name | |
| Last name | Yamamoto |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Orthodontics and Dentofacial Orthopedics
Zip code
980-8575
Address
4-1, Seiryomachi, Aoba-ku, Sendai, 980-8574, Japan
TEL
0227178374
Homepage URL
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
Division of Orthodontics and Dentofacial Orthopedics, Tohoku University Graduate School of Dentistry
Address
4-1, Seiryomachi, Aoba-ku, Sendai, 980-8574, Japan
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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 18 | 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
25
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
Completed
Date of protocol fixation
| 2012 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2012 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 15 | Day |
Last modified on
| 2020 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016021
