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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000025000
Receipt No. R000028762
Scientific Title Effect of Bifidobacteria intake on oral environment
Date of disclosure of the study information 2017/01/15
Last modified on 2018/03/30

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Basic information
Public title Effect of Bifidobacteria intake on oral environment
Acronym Effect of Bifidobacteria intake on oral environment
Scientific Title Effect of Bifidobacteria intake on oral environment
Scientific Title:Acronym Effect of Bifidobacteria intake on oral environment
Region
Japan

Condition
Condition Chronic Periodontitis
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effectiveness of Bifidobacteria intake on oral environment of chronic peridontitis patient during maintenance phase.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Bacterial flora(Saliva, subgingival plaque)
Porphyromonas gingivalis, Treponema denticola, Tannerella forsythensis
(Observation period; 4 months)
Key secondary outcomes Ig A (Saliva)
Probing pocket depth
Bleeding on probing
Gingival index

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Bifidobacterium containing yogurt intake once a day for 8 weeks
Interventions/Control_2 Bifidobacterium non-containing yogurt intake once a day for 8 weeks
Interventions/Control_3 Sham control
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Chronic Periodontitis
Maintenance phase
Probing pocket depths 5mm<=, =>7mm
Key exclusion criteria Patients with serious disease
Allergy in food (especially dairy product)
Smoker
Lactating period
Pregnant
Antibiotics intake during 3 months
Antiplatelet agent intake
Yogurt, fermented milk drink and intestinal drug intake more than three times a week during 3 months
Participated in other clinical trials during one month
Drugs, supplements and foods which affect the result of the trial
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichi Izumi
Organization Tokyo Medical and Dental University
Division name Department of Periodontology
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5488
Email y-izumi.peri@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Akizuki
Organization Tokyo Medical and Dental University
Division name Department of Periodontology
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5488
Homepage URL
Email akizuki.peri@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Meiji Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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 15 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 Terminated
Date of protocol fixation
2016 Year 11 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 15 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 11 Month 25 Day
Last modified on
2018 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028762

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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