UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Consideration of oral care in growing female athletes
Title of the study (Brief title)	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	Kumiko Ebi
Organization	Ritsumeikan University
Division name	Faculty of Sport and Health Science
Address	1-1-1 Nojihigashi, Kusatsu, Shiga
TEL	077-599-4128
Email	ab@fc.ritsumei.ac.jp

Public contact
Name of contact person	Kumiko Ebi
Organization	Ritsumeikan University
Division name	Faculty of Sport and Health Science
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 12 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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