UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized double-blind study for the effect of theaflavin on oral bacterial flora
Title of the study (Brief title)	Randomized double-blind study for the effect of theaflavin on oral bacterial flora
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the effect of teaflavin on oral bacterial flora
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Periodontopathic-bacteria after taking teaflavin tablets for 3 or 6 weeks (1.P.gingivalis 2.F.nucleatum)
Key secondary outcomes	Following indicators after taking teaflavin tablets for 3 or 6 weeks 1) Gingival index:GI 2) Plaque index: PI 3) Bleeding on Probing: BOP 4) Cariogenic bacteria

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are 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	Theaflavin tablet, 8 mg/2tablets/day, 6 weeks
Interventions/Control_2	Placebo tablet, 0 mg/2 tablets/day, 6 weeks
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	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Subjects who are not appropriate to examine oral bacterial flora 2. Subjects who are not under treatment for dental caries and/or periodontal disease and have enough tooth (20 tooth<=)
Key exclusion criteria	1. Subjects who are under treatment with mouse rinse 2. Subjects with diabetes, CKD, gastrointestinal diseases, lung diseases and/or cancer. 3. Subjects who are not appropriate to amount and pH of saliva. 4. Subjects with dental caries and/or periodontal disease 5. Subjects using removable denture 6. Antibiotics 7. drug and/or alcohol dependence 8. Pregnancy and nursing 9. Subjects who participate in other clinical trials at the time of this study entry
Target sample size	56

Research contact person
Name of lead principal investigator	Tatsuya Morimoto
Organization	Pharmaceutical Science, University of Shizuoka
Division name	Division of Molecular Medicine
Address	52-1 Yada, Suruga-ku, Shizuoka
TEL	0542645763
Email	morimoto@u-shizuoka-ken.ac.jp

Public contact
Name of contact person	Eiji Yoshikawa
Organization	KSO Corporation
Division name	Sales department
Address	1-9-7 Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	yoshikawa@kso.co.jp

Sponsor
Institute	University of Shizuoka
Institute
Department

Funding Source
Organization	Shizuoka industrial foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2015 Year 12 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 27 Day
Anticipated trial start date	2015 Year 11 Month 28 Day
Last follow-up date	2016 Year 02 Month 28 Day
Date of closure to data entry	2016 Year 03 Month 03 Day
Date trial data considered complete	2016 Year 03 Month 16 Day
Date analysis concluded	2016 Year 03 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 12 Month 03 Day
Last modified on	2019 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023155