UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055815 |
|---|---|
| Receipt number | R000063797 |
| Scientific Title | Inhibitory effect on the adherence of dental plaque in human study |
| Date of disclosure of the study information | 2024/10/11 |
| Last modified on | 2024/10/11 18:59:42 |
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Basic information
Public title
Inhibitory effect on the adherence of dental plaque in human study
Acronym
Prevention of dental caries using cyclodextran
Scientific Title
Inhibitory effect on the adherence of dental plaque in human study
Scientific Title:Acronym
Inhibitory effect of dental caries by cyclodextran
Region
| Japan |
Condition
Condition
Dental caries
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Estimation of the inhibitory effect of dental caries by cyclodextran
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Dental plaque score before and after of this protocol
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) 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
The volunteers drink 200ml cyclodextran at every meal and 100ml cyclodextran before sleeping.
Interventions/Control_2
The volunteers drink 200ml water at every meal and 100ml cyclodextran before sleeping.
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
1. Each is informed of the contents of the study and provided signed consent.
2. Over 20 years old
3. Male and females
Key exclusion criteria
1. Individual with specific general or oral health conditions
2. The number of mutans streptococci in unstimulated whole saliva samples obtained at the initial examination is less than 103 cfu/ml.
3. Fully crowns or restored abutments from excluded from determination of total number of teeth.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Michiyo |
| Middle name | |
| Last name | Matsumoto-Nakano |
Organization
Okayama University
Division name
Faculty of Medicine, Dentistry and Pharmaceutical Sciences
Zip code
800-7558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
TEL
086-235-6715
mnakano@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Michiyo |
| Middle name | |
| Last name | Matsumoto-Nakano |
Organization
Okayama University
Division name
Faculty of Medicine, Dentistry and Pharmaceutical Sciences
Zip code
800-7558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
TEL
086-235-6715
Homepage URL
mnakano@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Wellneo Sugar 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 Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
Tel
086-235-6938
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 11 | 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
| 2024 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 10 | Month | 11 | Day |
Last modified on
| 2024 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063797
