UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032268 |
|---|---|
| Receipt number | R000036799 |
| Scientific Title | Measurement of oral humidity using exhaled breath moisture detecting device |
| Date of disclosure of the study information | 2018/04/16 |
| Last modified on | 2020/04/19 22:05:09 |
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Basic information
Public title
Measurement of oral humidity using exhaled breath moisture detecting device
Acronym
Objective measurement of dry mouth
Scientific Title
Measurement of oral humidity using exhaled breath moisture detecting device
Scientific Title:Acronym
Objective measurement of dry mouth
Region
| Japan |
Condition
Condition
dry mouth , xerostomia
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Measurement of oral humidity
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Measurement of oral humidity between dry mouth patient and normal subject
Key secondary outcomes
Relationship between salivary volume and dry mouth feeling.
Objective measurement of dry mouth.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Oral humidity will be measured in the vicinity of salivary volume measurement, under resting and stimulating condition.Interventions is once.Dry mouth patient.
Interventions/Control_2
Oral humidity will be measured in the vicinity of salivary volume measurement, under resting and stimulating condition.Interventions is once.Normal subject.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Aged 20 over. People can giving consent in writing, consulting usual oral care and examination, having no problems about oral and swallowing function and keeping breath hold during 5 seconds are possible.
Key exclusion criteria
Aged 20 under. People can't giving consent in writing, consulting usual oral care and examination, having no problems about oral and swallowing function and keeping breath hold during 5 seconds are impossible.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Tsunoda |
Organization
Keio University
Division name
Oral surgery
Zip code
160-8582
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo
TEL
03-5363-3831
tsunoda@keio.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Ikeura |
Organization
Keio University
Division name
Oral surgery
Zip code
160-8582
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo
TEL
03-5363-3831
Homepage URL
kazuhiro-0516@z2.keio.jp
Sponsor or person
Institute
Keio University department of oral surgery
Institute
Department
Personal name
Funding Source
Organization
Keio University department of oral surgery
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hitachi, Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Certified Review Board of Keio
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-5363-3503
med-nintei-jimu@adst.keio.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
| 2018 | Year | 04 | Month | 16 | 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
32
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
| 2018 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 16 | Day |
Last modified on
| 2020 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036799
