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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025475
Receipt No. 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

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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
Email 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
Email ab@fc.ritsumei.ac.jp

Sponsor
Institute Ritsumeikan University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029312

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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