UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025475 |
|---|---|
| Receipt number | R000029312 |
| Scientific Title | Consideration of oral care in growing female athletes |
| Date of disclosure of the study information | 2017/01/05 |
| Last modified on | 2016/12/29 06:17:16 |
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Basic information
Public title
Consideration of oral care in growing female athletes
Acronym
Consideration of oral care in growing female athletes
Scientific Title
Consideration of oral care in growing female athletes
Scientific Title:Acronym
Consideration of oral care in growing female athletes
Region
| Japan |
Condition
Condition
Periodontal disease, dental caries.
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the influence on oral condition of growing female athletes and effectiveness of oral care by probiotics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of periodontal bacteria
Key secondary outcomes
Clinical parameter (probing depth, bleeding on probing, plaque control record)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Lactobacillus salivarius TI2711
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
| 16 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Female
Key inclusion criteria
Female students belonging to the exercise club
Key exclusion criteria
Persons who received medication such as antibiotics
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kumiko Ebi |
Organization
Ritsumeikan University
Division name
Faculty of Sport and Health Science
Zip code
Address
1-1-1 Nojihigashi, Kusatsu, Shiga
TEL
077-599-4128
ab@fc.ritsumei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kumiko Ebi |
Organization
Ritsumeikan University
Division name
Faculty of Sport and Health Science
Zip code
Address
1-1-1 Nojihigashi, Kusatsu, Shiga
TEL
077-599-4128
Homepage URL
ab@fc.ritsumei.ac.jp
Sponsor or person
Institute
Ritsumeikan University
Institute
Department
Personal name
Funding Source
Organization
Koikeya Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokai University
Nihon University
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
| 2017 | Year | 01 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 12 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 29 | Day |
Last modified on
| 2016 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029312
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
