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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028545
Receipt No. R000032665
Scientific Title Comparative study of the therapeutic effects on periodontal disease using by antibiotics or probiotics
Date of disclosure of the study information 2019/04/01
Last modified on 2017/08/07

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Basic information
Public title Comparative study of the therapeutic effects on periodontal disease using by antibiotics or probiotics
Acronym Therapeutic effects of antibiotics and probiotics in periodontal disease
Scientific Title Comparative study of the therapeutic effects on periodontal disease using by antibiotics or probiotics
Scientific Title:Acronym Therapeutic effects of antibiotics and probiotics in periodontal disease
Region
Japan

Condition
Condition chronic periodontal disease
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Therapeutic effects and prognostic implication of the treatment using antibiotics or probiotics for periodontal disease are compared. In addition to clinical finding, the changes of bacterial flora in the intestines and the oral cavity are evaluated.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Degree of periodontitis at 16 weeks after treatment start
Key secondary outcomes Bacterial composition of the oral cavity and the intestine

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine Food
Interventions/Control_1 Intake of Lactobacillus salivarius WB21-containing tablet for 16 weeks
Interventions/Control_2 Intake of placebo tablet for 16 weeks
Interventions/Control_3 Local administration of minocycline hydrochloride for 2 weeks
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

Not applicable
Gender Male and Female
Key inclusion criteria Outpatients with moderate or higher chronic periodontitis
Key exclusion criteria Minors, people who took antibiotics in the past 3 months, those with severe metabolic disorders (diabetes, liver disease, kidney disease) or malignant tumors, those with dairy allergy
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nao Taniguchi
Organization Fukuoka Dental College
Division name Department of Preventive and Public Health Dentistry
Zip code
Address 2-15-1, Tamura Sawara-ku, Fukuoka, Japan
TEL +81-92-801-0411
Email naojsz@college.fdcnet.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nao Taniguchi
Organization Fukuoka Dental College
Division name Department of Preventive and Public Health Dentistry
Zip code
Address 2-15-1, Tamura Sawara-ku, Fukuoka, Japan
TEL +81-92-801-0411
Homepage URL
Email naojsz@college.fdcnet.ac.jp

Sponsor
Institute Fukuoka Dental College
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization

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
2019 Year 04 Month 01 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 Enrolling by invitation
Date of protocol fixation
2017 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 01 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
2017 Year 08 Month 05 Day
Last modified on
2017 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032665

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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