UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054875 |
|---|---|
| Receipt number | R000062692 |
| Scientific Title | Cohort study to evaluate the effect of inhalation pure oxygen under Hyperbaric environment to saliva secretion, saliva components, and oral microbiome |
| Date of disclosure of the study information | 2024/07/05 |
| Last modified on | 2025/05/01 16:09:29 |
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Basic information
Public title
Effect of inhalation pure Oxygen under Hyperbaric environment to saliva secretion, saliva components, and oral microbiome
Acronym
Effect of Inhalation Oxygen under Hyperbaric environment to oral
Scientific Title
Cohort study to evaluate the effect of inhalation pure oxygen under Hyperbaric environment to saliva secretion, saliva components, and oral microbiome
Scientific Title:Acronym
Effect of inhalation pure oxygen under Hyperbaric environment to saliva secretion, saliva components, and oral microbiome
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the possibility that Hyperbaric oxygen treatment improve oral environment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Saliva and dental plaque are collected at just after, 24h after, 1/2/3/4 week after intervention, and evaluate the items below.
saliva secretion
saliva buffer capacity
IgA, beta-defensin2, LL-37 of saliva
oral microbiome
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Inhalation pure oxygen under Hyperbaric environment at 2.5 atmospheres for 10 days (2 hours per day)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
18 years or older of healthy adults
Key exclusion criteria
Dental and oral problem
Jaw function problem
Pneumothorax
Chronic thromboembolic pulmonary disease
Cardiopulmonary dysfunction
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kairi |
| Middle name | |
| Last name | Hayashi |
Organization
Institute of Science Tokyo
Division name
masticatory function and health science
Zip code
1138510
Address
1-5-45 Yushima Bunkyo-city Tokyo
TEL
0358035227
k.hayashi.spmd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Kairi |
| Middle name | |
| Last name | Hayashi |
Organization
Institute of Science Tokyo
Division name
masticatory function and health science
Zip code
113-8510
Address
1-5-45 Yushima Bunkyo-city Tokyo
TEL
0358035227
Homepage URL
k.hayashi.spmd@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Kairi Hayashi
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute of Science Tokyo
Address
1-5-45 Yushima Bunkyo-city Tokyo
Tel
0358035227
info.bec@tmd.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
東京科学大学病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 05 | 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
| 2024 | Year | 06 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 07 | Month | 04 | Day |
Last modified on
| 2025 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062692
