UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042323 |
|---|---|
| Receipt number | R000048262 |
| Scientific Title | The exploratory study for the effect of test food on oral malodor |
| Date of disclosure of the study information | 2020/11/05 |
| Last modified on | 2020/10/29 15:23:51 |
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Basic information
Public title
The exploratory study for the effect of test food on oral malodor
Acronym
The exploratory study for the effect of test food on oral malodor
Scientific Title
The exploratory study for the effect of test food on oral malodor
Scientific Title:Acronym
The exploratory study for the effect of test food on oral malodor
Region
| Japan |
Condition
Condition
Oral malodor
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of test food on oral malodor
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concentration of volatile sulfur compounds in oral air
Key secondary outcomes
Concentrations of hydrogen sulfide and methyl mercaptan in oral air, Evaluation of tongue-coating status, Oral moisture, Salivary multi-test system
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single ingestion of test food
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
| 50 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Subjects aged 50-74 years
2) Subjects who have volatile sulfur compounds in mouth air above the olfactory threshold (hydrogen sulfide =>1.5 ng/10 ml and methyl mercaptan =>0.5 ng/10 ml air)
Key exclusion criteria
1) Subjects who have a history of serious disorders in liver, kidney, heart, lung, gastro-intestine, blood, endocrine system, or metabolic system etc.
2) Subjects who have dental treatment such as caries and periodontal disease
3) Subjects who had treatment with antibiotics in the past 1 month, or ones who are expected to have treatment with antibiotics
4) Subjects who participated in other clinical studies in the past 1 month
5) Subjects with milk allergy
6) Subjects who are judged inappropriate to this trial by the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Yoshida |
Organization
Matsumoto Dental University
Division name
Department of Oral Microbiology
Zip code
3990781
Address
1780 Gobara Hiro-oka, Shiojiri, Nagano, 399-0781 Japan
TEL
0263-51-2082
akihiro.yoshida@mdu.ac.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Yoshida |
Organization
Matsumoto Dental University
Division name
Department of Oral Microbiology
Zip code
3990781
Address
1780 Gobara Hiro-oka, Shiojiri, Nagano, 399-0781 Japan
TEL
0263-51-2082
Homepage URL
akihiro.yoshida@mdu.ac.jp
Sponsor or person
Institute
Matsumoto Dental University
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co., Ltd.
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
Matsumoto Dental University , Clinical Research Review Board
Address
1780 Gobara Hiro-oka, Shiojiri, Nagano, 399-0781 Japan
Tel
0263-51-2188
info_kakenhi@mdu.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
| 2020 | Year | 11 | Month | 05 | 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
| 2020 | Year | 09 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 12 | 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
| 2020 | Year | 11 | Month | 02 | Day |
Last modified on
| 2020 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048262
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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