UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057918 |
|---|---|
| Receipt number | R000065980 |
| Scientific Title | Application of electric potential stimulation in orthodontic treatment |
| Date of disclosure of the study information | 2025/05/20 |
| Last modified on | 2025/05/20 12:53:36 |
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Basic information
Public title
Effect of electric potential stimulation on tooth movement rate and pain during orthodontic treatment
Acronym
Effect of electric potential stimulation on tooth movement rate and pain during orthodontic treatment
Scientific Title
Application of electric potential stimulation in orthodontic treatment
Scientific Title:Acronym
Application of electric potential stimulation in orthodontic treatment
Region
| Japan |
Condition
Condition
malocclusion
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of electrical stimulation on promoting tooth movement, shortening treatment time, and alleviatingpainduringorthodontic treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patients diagnosed as requiring orthodontic treatment will be divided into two groups: an intervention group receiving electrical stimulation and a control group not receiving electrical stimulation. The study will evaluate whether there are differences in tooth movement promotion, treatment duration reduction, and pain relief between the two groups.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Group receiving electrical stimulation diagnosed as requiring orthodontic treatment
Interventions/Control_2
Group not receiving electrical stimulation who were diagnosed as requiring orthodontic treatment
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
| 13 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 13 years or older who are visiting the Orthodontic Department of Kanagawa Dental University Hospital and have been diagnosed as requiring orthodontic treatment.
Key exclusion criteria
Those who use medical electronic devices that are susceptible to electromagnetic interference, such as pacemakers,implantabledefibrillators, and electrocardiographs.
Those with heart disease.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | So |
| Middle name | |
| Last name | Koizumi |
Organization
Kanagawa Dental University Graduate School
Division name
Orthodontics course
Zip code
238-8580
Address
82 Inaoka-cho, Yokosuka City, Kanagawa Prefecture
TEL
046-822-8813
koizumi@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Hayato |
| Middle name | |
| Last name | Furuhashi |
Organization
Kanagawa Dental University Graduate School
Division name
Orthodontics course
Zip code
238-8580
Address
82 Inaoka-cho, Yokosuka City, Kanagawa Prefecture
TEL
046-822-8813
Homepage URL
furuhasi@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental College
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Dental College
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
Kanagawa Dental University Graduate School
Address
82 Inaoka-cho, Yokosuka City, Kanagawa Prefecture
Tel
046-822-8813
furuhasi@kdu.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
| 2025 | Year | 05 | Month | 20 | 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
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2028 | Year | 03 | 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
| 2025 | Year | 05 | Month | 20 | Day |
Last modified on
| 2025 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065980
