UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019996 |
|---|---|
| Receipt number | R000023085 |
| Scientific Title | A study on the safety of low-power laser therapy for mental nerve paresthesia |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2019/06/22 05:01:41 |
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Basic information
Public title
A study on the safety of low-power laser therapy for mental nerve paresthesia
Acronym
The study of low-power laser therapy for mental nerve paresthesia
Scientific Title
A study on the safety of low-power laser therapy for mental nerve paresthesia
Scientific Title:Acronym
The study of low-power laser therapy for mental nerve paresthesia
Region
| Japan |
Condition
Condition
mental nerve paresthesia
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of low-power laser therapy for mental nerve paresthesia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Perception test
The measured every consultation Date
Key secondary outcomes
SW perception tester
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
5 minutes each affected area to direct irradiation (oral mucosa and skin), frequency of treatment once a week, about three months implementation
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Oral surgery cases who visited the Kyoto Prefectural University of Medicine Hospital Dentistry.
Underwent surgery under general anesthesia, patients with mental nerve disorder after surgery.
Key exclusion criteria
nothing
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toshiro |
| Middle name | |
| Last name | Yamamoto |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Dental Medicine
Zip code
602-0841
Address
465 Kajiicho, Kamigyoku, Kyoto
TEL
075-251-5641
yamamoto@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Toshiro |
| Middle name | |
| Last name | Yamamoto |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Dental Medicine
Zip code
602-0841
Address
465 Kajiicho, Kamigyoku, Kyoto
TEL
075-251-5641
Homepage URL
yamamoto@koto.kpu-m.ac.jp
Sponsor or person
Institute
Co., Ltd. wave length
Institute
Department
Personal name
Funding Source
Organization
Co., Ltd. wave length
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Independent Ethics Committee, Kyoto Prefectural University of Medicine
Address
465 Kajiicho, Kamigyoku, Kyoto
Tel
075-251-5337
rinri@koto.kpu-n.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 | 12 | Month | 01 | 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
0
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
Terminated
Date of protocol fixation
| 2015 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 22 | 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 | 11 | Month | 30 | Day |
Last modified on
| 2019 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023085
