UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020049 |
|---|---|
| Receipt number | R000023155 |
| Scientific Title | Randomized double-blind study for the effect of theaflavin on oral bacterial flora |
| Date of disclosure of the study information | 2015/12/03 |
| Last modified on | 2019/03/01 16:43:55 |
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Basic information
Public title
Randomized double-blind study for the effect of theaflavin on oral bacterial flora
Acronym
Randomized double-blind study for the effect of theaflavin on oral bacterial flora
Scientific Title
Randomized double-blind study for the effect of theaflavin on oral bacterial flora
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Tatsuya Morimoto |
Organization
Pharmaceutical Science, University of Shizuoka
Division name
Division of Molecular Medicine
Zip code
Address
52-1 Yada, Suruga-ku, Shizuoka
TEL
0542645763
morimoto@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Yoshikawa |
Organization
KSO Corporation
Division name
Sales department
Zip code
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
yoshikawa@kso.co.jp
Sponsor or person
Institute
University of Shizuoka
Institute
Department
Personal name
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)
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
| 2015 | Year | 12 | Month | 03 | 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
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
| 2015 | Year | 11 | Month | 27 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023155
