UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062706 |
|---|---|
| Receipt number | R000071799 |
| Scientific Title | A Clinical Study to Evaluate the Preventive Effects of a Dentifrice Containing Two Antibacterial Agents and Anti-inflammatory/Anti-bleeding Ingredients on Periodontal Disease |
| Date of disclosure of the study information | 2026/10/03 |
| Last modified on | 2026/08/27 09:29:23 |
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Basic information
Public title
A Clinical Study to Evaluate the Preventive Effects of a Dentifrice Containing Two Antibacterial Agents and Anti-inflammatory/Anti-bleeding Ingredients on Periodontal Disease
Acronym
A Clinical Study to Evaluate the Preventive Effects of a Dentifrice Containing Two Antibacterial Agents and Anti-inflammatory/Anti-bleeding Ingredients on Periodontal Disease
Scientific Title
A Clinical Study to Evaluate the Preventive Effects of a Dentifrice Containing Two Antibacterial Agents and Anti-inflammatory/Anti-bleeding Ingredients on Periodontal Disease
Scientific Title:Acronym
A Clinical Study to Evaluate the Preventive Effects of a Dentifrice Containing Two Antibacterial Agents and Anti-inflammatory/Anti-bleeding Ingredients on Periodontal Disease
Region
| Japan |
Condition
Condition
Healthy male/female volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To comprehensively evaluate the effects of four weeks of use of the study-product on periodontal disease and to confirm its efficacy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Gingivitis index
2. Dental plaque index
3. Depth of periodontal pocket
4. Bleeding on Probing
Key secondary outcomes
1.Swelling
2.Redness
3.Overall effectiveness
4.Tongue Coating Score
5.Volatile Sulfur Compound (VSC) Concentration
6.Periodontal Inflamed Surface Area (PISA),Periodontal Epithelial Surface Area (PESA)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Continuous application of the toothpaste to the subjects, three times a day for 4 weeks.
Interventions/Control_2
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy male/female volunteers ranging in age from 40 to 64 years old.
Volunteers having mild-to-moderate gingivitis and/or periodontitis.
According to the clinical observation, volunteers having not less than one periodontal pocket with not less than 4 mm.
At the screening test, volunteers who were determined as a patient having not less than one tooth equipped with level-1 or 2 on the GI index.
Volunteers having no scaling about the observation region within the last one month to the current study.
Volunteers who habitually brush their teeth at least three times per day.
Volunteers having not less than four teeth whose labial/buccal surfaces are measurable among the six index teeth (FDI: 16, 12, 24, 36, 32, 44), or their alternatives (FDI: 17, 15, 11, 25, 37, 35, 31, 45).
Volunteers are not currently receiving treatment for some kind of periodontal disease and who have at least 20 teeth present.
Volunteers who gave informed consent to take part in this study after being provided with anexplanation of the protocol detail.
Key exclusion criteria
Volunteers judged as having dental caries (C3 or worse) or severe periodontal disease at the screening test.
Volunteers receiving medical treatment for diabetes, chronic kidney, digestive, lung or cancer diseases.
Volunteers having some kind of systemic disease, which has serious difficulty in participating in this study.
Volunteers with toothbrushing not less than five times a day.
Volunteers cannot stop taking or using medicines that may affect oral health during the study period.
Volunteers use dentifrices equivalent to the investigational product, professional-use dentifrices, or other dentifrices, mouthwashes that may affect the study results.
Women who are pregnant, breastfeeding, or planning to become pregnant during the study period.
Volunteers having their stimulated saliva with no more than 3.0 mL for 5 min and having been diagnosed with dry mouth.
Volunteers having stimulated saliva with no more than a pH of 6.2.
Volunteers having experience of allergies to the components of research products, metals, or medicines.
Volunteers equipped with removable denture, and/or dental implant on the evaluated teeth.
Volunteers currently undergoing orthodontic treatment.
Volunteers currently smoke.
Volunteers who have regularly used some kind of health food.
Volunteers who have took in some kind of antibiotic and/or antibacterial agent, regularly or within the last month to the screening test.
Volunteers currently participating in or willing to participate in research on other pharmaceuticals or foods, or research on applying cosmetics or drugs
Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Ito |
Organization
DAIICHI SANKYO HEALTHECARE CO.,LTD.
Division name
Research Division
Zip code
140-8710
Address
1-2-58 Hiromachi, Shinagawa-ku, Tokyo 140-8710, Japan
TEL
03-5255-6222
shinji.ito@daiichisankyo.com
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numazu |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
Shibaura Omodaka Building 7F, 1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO HEALTHCARE CO., LTD
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
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gumma
Tel
027-212-5608
sagawa@mc-connect.co.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
| 2026 | Year | 10 | Month | 03 | 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 | 07 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 12 | 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 | 08 | Month | 27 | Day |
Last modified on
| 2026 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071799
