UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041952 |
|---|---|
| Receipt number | R000047877 |
| Scientific Title | Changes in cerebral blood flow and saliva volume induced by near-infrared radiation |
| Date of disclosure of the study information | 2020/10/15 |
| Last modified on | 2020/09/30 16:27:29 |
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Basic information
Public title
Changes in cerebral blood flow and saliva volume induced by near-infrared radiation
Acronym
Changes in cerebral blood flow and saliva volume induced by near-infrared radiation
Scientific Title
Changes in cerebral blood flow and saliva volume induced by near-infrared radiation
Scientific Title:Acronym
Changes in cerebral blood flow and saliva volume induced by near-infrared radiation
Region
| Japan |
Condition
Condition
Dry mouse, bruxism, periodontal disease, and dementia
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Near-infrared radiation acts to increase blood flow by non-invasively dilating blood vessels. Continued tension in the perioral muscles, such as from bruxism, can reduce cerebral blood flow, contributing to migraine headaches, dementia and cerebrovascular disease. It has been reported that gingival massage increased blood flow to the prefrontal cortex ( T. Rikimaru et al., A study on the changes in the activity of the prefrontal cortex by intraoral brushing, Geriatrics, 29 (4), 2015), therefore, in this study, we used non-invasive near-infrared light to irradiate and massage the gingiva And to what extent cerebral blood flow is increased, including changes in saliva volume.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Cerebral blood flow and saliva volume will be measured before the study begins. Saliva will be collected using a salivator and resting saliva volume will be measured. Next, the subjects will wear near-infrared spectroscopy (NIRS) and be irradiated with near-infrared radiation for 30 seconds to one minute at a time in eight blocks according to the irradiation manual. The subjects were irradiated with near-infrared light for 30 seconds to one minute at a time, according to the irradiation manual, in eight blocks. The rate of change in the signal at this time was measured by NIRS. As a control, we will measure the change in cerebral blood flow rate of the gingival massage in the same order and at the same time as the experimental group.
Key secondary outcomes
Near-infrared irradiation was continued for one week at home after brushing the teeth at night according to the irradiation manual, and saliva was collected again after one week to compare saliva levels.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Intraoral near-infrared radiation equipment is divided into eight blocks, and the gums are irradiated for a total of six minutes for 30 to 60 seconds per block. As the irradiation takes place, there is a gingival massage effect by vibration. The rate of change in the signal is measured by NIRS.
Interventions/Control_2
The subjects are divided into eight blocks, and each block is divided into 30 to 60 seconds for a total of six minutes without near-infrared radiation. The rate of change in the signal at this time was measured by NIRS.
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
People with no underlying disease
Key exclusion criteria
People who are sick or on long-term medication
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Wakako |
| Middle name | |
| Last name | Sakaguchi |
Organization
Kanagawa dental university
Division name
Division of Oral Sciences
Zip code
2380003
Address
82 Inaoka-cho, Yokosuka-shi, Kanagawa
TEL
046-822-9537
sakagichi@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Wakako |
| Middle name | |
| Last name | Sakaguchi |
Organization
Kanagawa dental university
Division name
Division of Oral Sciences
Zip code
2380003
Address
82 Inaoka-cho, Yokosuka-shi, Kanagawa
TEL
046-822-9537
Homepage URL
sakagichi@kdu.ac.jp
Sponsor or person
Institute
Kanagawa dental university
Division of Oral Sciences
Institute
Department
Personal name
Funding Source
Organization
Kanagawa dental university
Division of Oral Sciences
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
Address
82 inaoka-cho yokosuka city kanagawa
Tel
046-822-9537
sakaguchi@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
| 2020 | Year | 10 | Month | 15 | 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
| 2020 | Year | 09 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2020 | Year | 09 | Month | 30 | Day |
Last modified on
| 2020 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047877
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| Registered date | File name |
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