UMIN-CTR Clinical Trial

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 Nao Middle name Last name Taniguchi
Organization	Fukuoka Dental College
Division name	Department of Preventive and Public Health Dentistry
Zip code	814-0193
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 Nao Middle name Last name Taniguchi
Organization	Fukuoka Dental College
Division name	Department of Preventive and Public Health Dentistry
Zip code	814-0193
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	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Fukuoka Dental College
Address	Tamura 2-15-1, Sawara-ku, Fukuoka
Tel	+81-92-801-0411
Email	shomu@college.fdcnet.ac.jp

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	https://www.jstage.jst.go.jp/article/jsb/75/1/75_60/_pdf/-char/ja
Publication of results	Partially published

Result
URL related to results and publications	https://www.jstage.jst.go.jp/article/jsb/75/1/75_60/_pdf/-char/ja
Number of participants that the trial has enrolled	30
Results	All samples were obtained in a 3-month study of 10 patients (5 experimental, 5 control). Clinical symptoms of periodontal disease improved in all patients. As a result of the oral and intestinal bacterial flora analysis, it was found that there was a difference in the increase and decrease of bacterial species between the experimental group and the control group.
Results date posted	2022 Year 08 Month 09 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Patients with periodontal disease who visited a dental clinic
Participant flow	Continuous intake of lactobacillus tablet or placebo during basic periodontal treatment
Adverse events	No problem
Outcome measures	probing pocket depth, bleeding on probing, oral microbiota, gut microbiota
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 05 Month 01 Day
Date of IRB	2017 Year 05 Month 09 Day
Anticipated trial start date	2017 Year 06 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
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	2022 Year 08 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032665