UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039392 |
|---|---|
| Receipt number | R000044915 |
| Scientific Title | Clinical study on the effect of continuous intake of Lactobacillus salivarius WB21 on maintaining the health of tissues around dental implants |
| Date of disclosure of the study information | 2022/03/31 |
| Last modified on | 2023/08/09 09:07:05 |
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Basic information
Public title
Clinical study on the effect of lactic acid bacterium WB21 on prognosis of dental implant
Acronym
Effect of lactic acid bacterium WB21 on prognosis of dental implant
Scientific Title
Clinical study on the effect of continuous intake of Lactobacillus salivarius WB21 on maintaining the health of tissues around dental implants
Scientific Title:Acronym
Effect of continuous intake of Lactobacillus salivarius WB21 on tissues around dental implants
Region
| Japan |
Condition
Condition
Dental outpatient with dental implant
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to maintain and promote the health of tissues around dental implants, we investigate whether continuous ingestion of lactic acid bacteria Lactobacillus salivarius WB21, which has been reported to suppress periodontitis and bad breath, can control inflammation around implants.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Implant site plaque index (PlI), gingival inflammation index (MGI), periodontal pocket (PPD), probing bleeding (BOP), secretory IgA in saliva
Key secondary outcomes
Questionnaire survey
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
Licking without chewing Lactobacillus salivarius WB21 tablet after eating and oral cleaning, 3 times a day, 1 tablet at a time.
Interventions/Control_2
Licking without chewing placebo tablet after eating and oral cleaning, 3 times a day, 1 tablet at a time.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing implant treatment for molars at the Department of Oral Implantology, Fukuoka Dental College Medical and Dental Hospital, and currently undergoing maintenance
Key exclusion criteria
(1) Allergy to dairy products
(2) Persons with poor general condition
(3) Person who smokes habitually
(4) Alcoholics
(5) Pregnant and nursing women
(6) Those who took antibiotics within 3 months
(7) Others who are deemed inappropriate by the researcher
Target sample size
30
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
TEL
092-801-0411
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
TEL
092-801-0411
Homepage URL
naojsz@college.fdcnet.ac.jp
Sponsor or person
Institute
Fukuoka Dental College
Institute
Department
Personal name
Funding Source
Organization
Fukuoka Gakuen
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 University General Affairs Division
Address
2-15-1 Tamura Sawara-ku, Fukuoka
Tel
092-801-0411
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
| 2022 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
23
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The manuscript is currently being written and is yet to be submitted.
Date of the first journal publication of results
| 2024 | Year | 03 | Month | 30 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2020 | Year | 02 | Month | 05 | Day |
Last modified on
| 2023 | 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=R000044915
