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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032268
Receipt No. 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 2019/05/06

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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
Email 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
Email kazuhiro-0516@z2.keio.jp

Sponsor
Institute Keio University department of oral surgery
Institute
Department

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
Email 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
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 Open public recruiting
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 04 Month 10 Day
Date trial data considered complete
2020 Year 04 Month 10 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
2019 Year 05 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036799

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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