UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053076 |
|---|---|
| Receipt number | R000058242 |
| Scientific Title | Exploratory Investigation of the Inhibitory Effect of Codium fragile Extract Lectin on Biofilm Formation on Human Tooth Surface |
| Date of disclosure of the study information | 2023/12/12 |
| Last modified on | 2023/12/12 17:47:10 |
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Basic information
Public title
Exploratory Investigation of the Inhibitory Effect of Codium fragile Extract Lectin on Biofilm Formation on Human Tooth Surface
Acronym
Inhibition of Dental Plaque Formation by Lectin from Seaweed "Codium fragile"
Scientific Title
Exploratory Investigation of the Inhibitory Effect of Codium fragile Extract Lectin on Biofilm Formation on Human Tooth Surface
Scientific Title:Acronym
Inhibition of Dental Plaque Formation by Lectin from Seaweed "Codium fragile"
Region
| Japan |
Condition
Condition
Oral Biofilm Infection
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An intervention study to investigate the inhibitory effect of Codium fragile-extract lectin on biofilm formation on tooth surfaces.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Change in the amount of bacteria on the tooth surface (calculated as ATP amount/area) after 6 hours
Key secondary outcomes
Changes in oral flora
Changes in cariogenic bacteria count, acidity, buffer capacity, leukocyte count, protein, and ammonia in saliva
Presence or absence of abnormal findings in the oral mucosa
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved 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
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Mouthwash with 15 mL of test mouthwash (0.05% CPC solution containing 1% Codium fragile extract) for 30 seconds once.
Interventions/Control_2
Mouthwash with 15 mL of control mouthwash (0.05% CPC solution without Codium fragile extract) for 30 seconds once.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
For able-bodied persons
Key exclusion criteria
Allergic to any of the tested materials (if allergic symptoms occur)
Pregnant or lactating mothers
Other subjects who are judged to be ineligible by the investigator based on their schedule or dental disease status.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Shogo |
| Middle name | |
| Last name | Takashiba |
Organization
Okayama University
Division name
Department of Pathophysiology - Periodontal Science Faculty of Medicine, Dentistry and Pharmaceutical Sciences Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Zip code
700-8525
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525, Japan
TEL
81-86-235-6675
stakashi@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Takashiba |
Organization
Okayama University
Division name
Pathophysiology - Periodontal Science Faculty of Medicine, Dentistry and Pharmaceutical Sciences
Zip code
700-8525
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525, Japan
TEL
086-235-6675
Homepage URL
stakashi@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Shogo Takashiba
Funding Source
Organization
Ichimaru Pharcos Co.Ltd.
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
Okayama University
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
Tel
086-235-6503
mae6605@adm.okayama-u.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
岡山大学病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 12 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 12 | Day |
Last modified on
| 2023 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058242
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