UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032015 |
|---|---|
| Receipt number | R000036535 |
| Scientific Title | Test to evaluate the function of the mouthpiece for measures against halitosis |
| Date of disclosure of the study information | 2018/04/02 |
| Last modified on | 2020/03/19 18:01:57 |
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Basic information
Public title
Test to evaluate the function of the mouthpiece for measures against halitosis
Acronym
Test to evaluate the function of the mouthpiece for measures against halitosis
Scientific Title
Test to evaluate the function of the mouthpiece for measures against halitosis
Scientific Title:Acronym
Test to evaluate the function of the mouthpiece for measures against halitosis
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Wear a special mouthpiece to those with strong bad breath and evaluate the effect of weakening halitosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Instrument measurement, evaluation of halitosis by Olfactory Measurement Operator, comparison of intergroup and intragroup
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are 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
Wear special mouthpiece for 8 weeks
Interventions/Control_2
8 weeks without wearing a special mouthpiece, no treatment
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Male and female under 20 years old and under 59
2. Who want to improve bad breath, or those who are told that they want you to improve bad breath
3. Those who can continue wearing test mouthpiece for 8 hours a day for 2 months when assigned to specimen loading group
4. Who can continue the test regardless of whether it is a test product use group or a non-use group
Key exclusion criteria
1. The following affected persons: diabetes, liver disease, kidney disease, severe periodontal disease, sinusitis, Sjogren's syndrome
2. Persons who are receiving hospital visits or doctor's prescription regarding bad breath
3. Those who consume health food related to bad breath
4. Who is participating in other exams
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masatomo Najima |
Organization
Japan Clinical Trial Association
Division name
N.A.
Zip code
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
info@yakujihou.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Kaneko |
Organization
Japan Clinical Trial Association
Division name
N.A.
Zip code
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
Homepage URL
info@yakujihou.org
Sponsor or person
Institute
Japan Clinical Trial Association
Institute
Department
Personal name
Funding Source
Organization
Bioclinic Tokyo
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
Address
Tel
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 | 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
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 30 | Day |
Last modified on
| 2020 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036535
