UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028545 |
|---|---|
| Receipt number | 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 | 2022/08/09 09:35:53 |
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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 | 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
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
naojsz@college.fdcnet.ac.jp
Sponsor or person
Institute
Fukuoka Dental College
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032665
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