UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013722
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email t-yamamo@m.tohoku.ac.jp

Sponsor
Institute Division of Orthodontics and Dentofacial Orthopedics, Tohoku University Graduate School of Dentistry
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016021

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.