UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037885 |
|---|---|
| Receipt number | R000043058 |
| Scientific Title | Exploratory study on usefulness of local odor detection device |
| Date of disclosure of the study information | 2019/09/02 |
| Last modified on | 2019/09/02 11:18:17 |
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Basic information
Public title
Exploratory study on usefulness of local odor detection device
Acronym
Study on usefulness of local odor detection device
Scientific Title
Exploratory study on usefulness of local odor detection device
Scientific Title:Acronym
Study on usefulness of local odor detection device
Region
| Japan |
Condition
Condition
Odor
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Adjusting the consistency between the detected value of the collected odor by using our developing device and the actual severity of bad breath.
Basic objectives2
Others
Basic objectives -Others
Evaluation of bad breath detection ability of the newly developed device
Trial characteristics_1
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The oral odor (especially sulfur-derived molecules) is measured with a new device.
Key secondary outcomes
Status of periodontal disease, oral cleaning, and odor.
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
| Device,equipment |
Interventions/Control_1
Measure oral bad breath in the oral cavity.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Men and women aged 20 and over at the time of consent acquisition.
2) Persons who obtained written consent by their own free will after sufficient explanation after participation in this study.
3) Patients with periodontal disease (gingivitis / periodontitis) or healthy subjects with no abnormal periodontal condition.
Key exclusion criteria
1) People with strong bad breath originating from systemic diseases (diabetes, respiratory diseases, digestive diseases, etc.).
2) People with a tendency to vomit reflex.
3) Women who are pregnant or may be pregnant.
4) Breastfeeding women
5) Other patients who are judged to be inappropriate as research subjects by the principal investigator or research investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Matsumoto |
Organization
Okayama University
Division name
Dept. of Biomaterials
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-6667
biomat@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Masako |
| Middle name | |
| Last name | Nakagawa |
Organization
Okayama University
Division name
Dept. of Biomaterials
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-6667
Homepage URL
biomat@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Medicalnet Corp
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
Okayama University
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
Tel
086-235-6667
biomat@md.okayama-u.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
| 2019 | Year | 09 | Month | 02 | 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
| 2019 | Year | 08 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2021 | 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
| 2019 | Year | 09 | Month | 02 | Day |
Last modified on
| 2019 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043058
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
