UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027724 |
|---|---|
| Receipt number | R000031739 |
| Scientific Title | Effect of oral care tablet on reduction of bacteria in tongue coating and oral malodor |
| Date of disclosure of the study information | 2017/07/31 |
| Last modified on | 2019/12/14 09:36:16 |
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Basic information
Public title
Effect of oral care tablet on reduction of bacteria in tongue coating and oral malodor
Acronym
Effect of oral care tablet
Scientific Title
Effect of oral care tablet on reduction of bacteria in tongue coating and oral malodor
Scientific Title:Acronym
Effect of oral care tablet
Region
| Japan |
Condition
Condition
Oral malodor
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effect of the oral care tablet on reduction of bacteria in tongue coating and oral malodor of university students
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of oral malodor Volatile sulfur compounds
H2S
CH3SH
Evaluation of tongue coating accumulation
Measurement of oral bacteria
Total bacteria
Porphyromonas gingivalis
Fusobacterium nucleatum
Campylobacter rectus Assessment of oral microbiome
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Tongue cleaning
Interventions/Control_2
Intake of oral care tablet
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
University student who obtained with informed consent of this study
Key exclusion criteria
Underlying disease
Smoker
Pregnant women
Intake of antibiotics within 2 weeks
Allergy against kiwi fruits and apple
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Hinode |
Organization
Tokushima University Graduate School of Biomedical Sciences
Division name
Department of Hygiene and Oral Health Science
Zip code
770-8504
Address
18-15 Kuramotocho 3-chome, Tokushima, 770-8504 JAPAN
TEL
088-633-7543
hinode@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Hinode |
Organization
Tokushima University Graduate School of Biomedical Sciences
Division name
Department of Hygiene and Oral Health Science
Zip code
770-8504
Address
18-15 Kuramotocho 3-chome, Tokushima, 770-8504 JAPAN
TEL
088-633-7543
Homepage URL
hinode@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokushima University Hospital
Address
Kuramotocho 2-50-1, Tokushima city
Tel
088-633-9294
first-ec@tokushima-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
| 2017 | Year | 07 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
32
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
| 2017 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 12 | Day |
Last modified on
| 2019 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031739
