UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057937 |
|---|---|
| Receipt number | R000066235 |
| Scientific Title | A study of the effects of Cyclo Isomaltooligosaccharide intake on plaque inhibition and caries development and progression |
| Date of disclosure of the study information | 2025/05/30 |
| Last modified on | 2025/05/22 12:41:18 |
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Basic information
Public title
A study of the effects of Cyclo Isomaltooligosaccharide intake on plaque inhibition and caries development and progression
Acronym
A study of the effect of Cyclo Isomaltooligosaccharide intake on dental caries
Scientific Title
A study of the effects of Cyclo Isomaltooligosaccharide intake on plaque inhibition and caries development and progression
Scientific Title:Acronym
A study of the effect of Cyclo Isomaltooligosaccharide intake on dental caries
Region
| Japan |
Condition
Condition
Dental caries
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to determine the clinical impact of Cyclo Isomaltooligosaccharide on the prevention of dental diseases and the enhancement of oral hygiene management.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
About 9 months after starting intake
- Visual examination of caries epidemiological indicators (ICDAS and DMF)
- Quantification of salivary biomarkers (S-IgA/LL-37/defensin)
- Analysis of oral flora
During intake period
Interviews regarding condition, vitality, health, etc., such as toothache, hypersensitivity,feeling unwell or having a cold
Key secondary outcomes
About 9 months after starting intake
- Quantification of salivary biomarkers (S-IgA/LL-37/defensin)
- Analysis of oral flora
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
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
| Food |
Interventions/Control_1
Intake of test food containing 600mg Cyclo Isomaltooligosaccharide per one day
Interventions/Control_2
Intake of test food not containing 600mg Cyclo Isomaltooligosaccharide per one day
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
-Those who are not undergoing active dental treatment.
-Those who have no caries requiring treatment as determined by a prior dental checkup.
-Those who have received an explanation of the study contents and have given written consent to participate in the study.
Key exclusion criteria
Those with serious systemic illnesses such as internal medicine
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | GEN |
| Middle name | |
| Last name | TANABE |
Organization
Meikai University
Division name
Department of Sports Dentistry
Zip code
350-0283
Address
Keyakidao 1-1, Sakado, Saiatama, Japan
TEL
049-279-2745
gem.spmd@dent.meikai.ac.jp
Public contact
Name of contact person
| 1st name | GEN |
| Middle name | |
| Last name | TANABE |
Organization
Meikai University
Division name
Department of Sports Dentistry
Zip code
350-0283
Address
Keyakidao 1-1, Sakado, Saiatama, Japan
TEL
049-279-2745
Homepage URL
gen.spmd@dent.meikai.ac.jp
Sponsor or person
Institute
Meikai University
Institute
Department
Personal name
Funding Source
Organization
WELLNEO SUGAR Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Chuo University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Meikai University
Address
Keyakidao 1-1, Sakado, Saiatama, Japan
Tel
049-279-2745
kyouin@dent.meikai.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
| 2025 | Year | 05 | Month | 30 | 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
| 2025 | Year | 05 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 22 | Day |
Last modified on
| 2025 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066235
