UMIN-CTR Clinical Trial

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
Email	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
Email	info@yakujihou.org

Sponsor
Institute	Japan Clinical Trial Association
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036535