UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062790 |
|---|---|
| Receipt number | R000071847 |
| Scientific Title | Effects of a Dental Rinse Containing Cetylpyridinium Chloride (CPC) and Coconut Oil Fatty Acid Acylarginine Ethyl DL-PCA Salt (CAE) on Plaque Accumulation, Gingivitis and Oral Microbiota: A Placebo-Controlled, Randomized, Double-Blind, Parallel-Group Comparative Study |
| Date of disclosure of the study information | 2026/09/02 |
| Last modified on | 2026/09/02 18:14:06 |
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Basic information
Public title
Effects of CPC/CAE-Containing Dental Rinse on Plaque, Gingivitis, and Oral Microbiota
Acronym
Effects of CPC/CAE-Containing Dental Rinse on Plaque, Gingivitis, and Oral Microbiota
Scientific Title
Effects of a Dental Rinse Containing Cetylpyridinium Chloride (CPC) and Coconut Oil Fatty Acid Acylarginine Ethyl DL-PCA Salt (CAE) on Plaque Accumulation, Gingivitis and Oral Microbiota: A Placebo-Controlled, Randomized, Double-Blind, Parallel-Group Comparative Study
Scientific Title:Acronym
Effects of a Dental Rinse Containing Cetylpyridinium Chloride (CPC) and Coconut Oil Fatty Acid Acylarginine Ethyl DL-PCA Salt (CAE) on Plaque Accumulation, Gingivitis and Oral Microbiota: A Placebo-Controlled, Randomized, Double-Blind, Parallel-Group Comparative Study
Region
| Japan |
Condition
Condition
Plaque accumulation and gingivitis
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of a CPC/CAE-containing dental rinse on plaque accumulation, gingivitis, and oral microbiota.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Plaque Index
Key secondary outcomes
Gingival Index (GI), Bleeding on Probing (BOP), Tongue Coating Index (TCI), supragingival plaque bacteria, resting saliva bacteria, and a questionnaire on oral hygiene habits and test products
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
From after screening until the end of the study, oral hygiene will be performed using designated toothpaste and toothbrush (twice daily). After the completion of the baseline assessment, in addition to the above, the use of a CPC/CAE-containing dental rinse twice daily will be initiated. The evaluation period will be 4 weeks, with intraoral examinations and plaque/saliva collection conducted every 2 weeks. Additionally, plaque and saliva collection will also be performed 1 day after the baseline assessment.
Interventions/Control_2
From after screening until the end of the study, oral hygiene will be performed using designated toothpaste and toothbrush (twice daily). After the completion of the baseline assessment, in addition to the above, the use of a placebo dental rinse twice daily will be initiated. The evaluation period will be 4 weeks, with intraoral examinations and plaque/saliva collection conducted every 2 weeks. Additionally, plaque and saliva collection will also be performed 1 day after the baseline assessment.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Individuals aged 20 years or older and under 70 years of age at the time of consent
2. Individuals from whom written informed consent has been obtained
3. Individuals who are able to comply with the visit schedule during the study period
4. Individuals who have 20 or more natural teeth
5. Individuals who present with moderate plaque accumulation and moderate gingivitis upon oral examination (representative 6 teeth) at screening (mean PI greater than 1, mean GI greater than 1)
Key exclusion criteria
1. Individuals with allergies to CPC, CAE, or GK2
2. Individuals with serious chronic diseases such as poorly controlled diabetes
3. Individuals who smoke 20 or more cigarettes per day
4. Individuals currently undergoing periodontal treatment or with severe periodontitis (mobile teeth or probing pocket depth of 6 mm or more)
5. Individuals with 5 or more untreated carious teeth
6. Individuals currently undergoing orthodontic treatment
7. Individuals who are pregnant, breastfeeding, or potentially pregnant
8. Individuals who have taken antibiotics within the past 1 month
9. Individuals deemed ineligible by the responsible dentist or dental hygienist
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Takako |
| Middle name | |
| Last name | Yasuda |
Organization
Sunstar Inc.
Division name
R&D
Zip code
658-0032
Address
Asia One Center 8F, 1-17 Koyochonaka, Higashinada-ku, Kobe, Hyogo, Japan
TEL
07029129057
takako.yasuda@sunstar.com
Public contact
Name of contact person
| 1st name | Takako |
| Middle name | |
| Last name | Yasuda |
Organization
Sunstar Inc.
Division name
R&D
Zip code
658-0032
Address
Asia One Center 8F, 1-17 Koyochonaka, Higashinada-ku, Kobe, Hyogo, Japan
TEL
07029129057
Homepage URL
takako.yasuda@sunstar.com
Sponsor or person
Institute
Sunstar Inc.
Institute
Department
Personal name
Funding Source
Organization
Sunstar Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Validity Evaluation Committee, Sunstar Inc.
Address
Asia One Center 8F, 1-17 Koyochonaka, Higashinada-ku, Kobe, Hyogo, Japan
Tel
08099374124
naoko.hayashi@sunstar.com
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
・サンスター株式会社（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 02 | 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
| 2026 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Participant recruitment will be outsourced to an external organization.
Management information
Registered date
| 2026 | Year | 09 | Month | 02 | Day |
Last modified on
| 2026 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071847
