UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060529 |
|---|---|
| Receipt number | R000069219 |
| Scientific Title | Non-inferiority study comparing the periodontal disease improvement effects of oral care formulations containing cetylpyridinium chloride (CPC) and beta-glycyrrhetinic acid with those containing chlorhexidine (CHX) |
| Date of disclosure of the study information | 2026/02/01 |
| Last modified on | 2026/01/30 20:04:55 |
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Basic information
Public title
Efficacy Tests for Toothpaste and Mouthwash
Acronym
Efficacy Tests for Toothpaste and Mouthwash
Scientific Title
Non-inferiority study comparing the periodontal disease improvement effects of oral care formulations containing cetylpyridinium chloride (CPC) and beta-glycyrrhetinic acid with those containing chlorhexidine (CHX)
Scientific Title:Acronym
Efficacy Tests for Toothpaste and Mouthwash
Region
| Japan |
Condition
Condition
Periodontal disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy of formulations containing CPC and beta-glycyrrhetinic acid in improving periodontal disease compared to formulations containing CHX.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Levels of active MMP-8 in gingival crevicular fluid (GCF) and salivary microbiota composition
Key secondary outcomes
Probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), plaque index (PlI), and IL-1beta levels in GCF
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Use of CPC + beta-glycyrrhetinic acid paste and liquid formulations at least twice daily for 3 months.
Interventions/Control_2
Use of chlorhexidine-containing paste and CHX + MAG liquid formulation at least twice daily for 3 months.
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) Patients who have received explanations about the purpose, content, and side effects of this study, fully understood them, voluntarily wished to participate in the study,
and provided written informed consent
(2) Patients who have 16 or more remaining teeth
(3) Patients who have stable teeth with a PPD of 4-8mm, excluding third molars
(4) Patients who are 20 years of age or older at the time of obtaining consent
Key exclusion criteria
(1) Patients who have been administered antibiotics (antimicrobial agents) within 1 month before the start of the study
(2) Patients currently being treated for cancer, stroke, acute myocardial infarction, diabetes, or autoimmune diseases
(3) Pregnant or breastfeeding individuals
(4) Smokers
(5) Patients who have experienced allergic reactions to toothpaste in the past
(6) Patients who are visiting a dental clinic and receiving treatment for oral diseases other than periodontal disease
(7) Patients currently participating in other clinical trials related to oral health
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Mitani |
Organization
School of Dentistry, Aichi Gakuin University
Division name
Department of Periodontology
Zip code
464-8651
Address
2-11 Suemori-dori, Chikusa-ku, Nagoya, Aichi
TEL
052-759-2150
minita@dpc.agu.ac.jp
Public contact
Name of contact person
| 1st name | Hisashi |
| Middle name | |
| Last name | Goto |
Organization
School of Dentistry, Aichi Gakuin University
Division name
Department of Periodontology
Zip code
464-8651
Address
2-11 Suemori-dori, Chikusa-ku, Nagoya, Aichi
TEL
052-759-2150
Homepage URL
hisashi@dpc.agu.ac.jp
Sponsor or person
Institute
Aichi Gakuin University
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
Aichi Gakuin University, School of Dentistry, Ethics Committee
Address
1-100 Kusumoto-cho, Chikusa-ku, Nagoya, Aichi
Tel
052-751-2561
None
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
愛知学院大学歯学部附属病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 01 | 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 | 08 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 01 | Month | 30 | Day |
Last modified on
| 2026 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069219
