UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057881 |
|---|---|
| Receipt number | R000066094 |
| Scientific Title | Usefulness evaluation study about improving the oral environment by longterm usage of toothpaste and mouth-rinse solution |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2025/05/13 16:03:51 |
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Basic information
Public title
Usefulness evaluation study about improving the oral environment by longterm usage of toothpaste and mouth-rinse solution
Acronym
Usefulness evaluation study about improving the oral environment by longterm usage of toothpaste and mouth-rinse solution
Scientific Title
Usefulness evaluation study about improving the oral environment by longterm usage of toothpaste and mouth-rinse solution
Scientific Title:Acronym
Usefulness evaluation study about improving the oral environment by longterm usage of toothpaste and mouth-rinse solution
Region
| Japan |
Condition
Condition
Healthy male/female volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to verify oral environment improvement effects by test-product usage for 4 weeks
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. Reddening
3. Overall effectiveness
4. Free Hb value / LDH activity in saliva
5. IL-1beta / IL-8 activity in saliva
6. Existence quantification of P.gingivalis/T.forsythensis/T.denticola/F.nucleatum in saliva
7. Tongue coating
8. Concentrations of volatile sulfur compounds, just like H2S and CH3SH and (CH3)2S
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Continuous application of the toothpaste to the subjects, three times a day (after every meal) for 4 weeks.
Interventions/Control_2
Continuous application of both the toothpaste and the solution to the subjects, three times a day (after every meal) for 4 weeks.
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
| 35 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy male/female volunteers ranging in age from 35 to 64 years old.
(2) Volunteers having mild-to-moderate gingivitis.
(3) According to the clinical observation, volunteers having not less than one periodontal pocket with not less than 4 mm.
(4) 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.
(5) Volunteers having no scaling about the observation region within the last one month to the current study.
(6) Volunteers usually having meals three times a day, and toothbrushing after each meal.
(7) Volunteers having not less than four teeth among measurable six ones (FDI: 16, 12, 24, 36, 32, 44), or their alternatives (FDI: 17, 15, 11, 25, 37, 35, 31, 45).
(8) Volunteers equipped with not less than 20 teeth, and without some kind of periodontal disease.
(9) Volunteers who gave informed consent to take part in this study after being provided with an
explanation of the protocol detail.
Key exclusion criteria
(1) At the screening test, volunteers who were determined as a patient having some dental caries (over C3 level) and/or severe periodontal disease.
(2) Volunteers with medical treatment for diabetic, chronic kidney, digestive, lung or cancer diseases.
(3) Volunteers having some kind of systemic disease, which has serious difficulty in participating in this study.
(4) Volunteers with toothbrushing not less than four times a day.
(5) Volunteers cannot stop taking or using medicines that may affect oral health during the study period.
(6) Pregnant, possibly pregnant, or lactating women, during this clinical study.
(7) Volunteers having their stimulating saliva with no more than 3.0 mL for 5 min and having been diagnosed with dry mouth.
(8) Volunteers having stimulating saliva with no more than a pH of 6.2.
(9) Volunteers having experience of allergies to the components of research products, metals, or medicines.
(10) Volunteers equipped with removable denture, and/or dental implant on the dental object.
(12) Volunteers falling into the habit of smoking.
(13) Volunteers who have regularly used some kind of health food.
(14) Volunteers who have took in some kind of antibiotic and/or antibacterial agent, regularly o
r within the last month to the screening test.
(15) Volunteers currently participating in or willing to participate in research on other pharmaceuticals or foods, or research on applying cosmetics or drugs
(16) 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 | Daijiro |
| Middle name | |
| Last name | Kawabata |
Organization
DAIICHI SANKYO HEALTHECARE CO.,LTD.
Division name
H&B Business Department
Zip code
103-8234
Address
3-14-10 Nihonbashi Chuo-ku Tokyo 103-3234, JAPAN
TEL
03-5255-6336
daijiro.kawabata@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, Gunma
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
| 2025 | Year | 06 | 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 | 02 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 15 | Day |
Last modified on
| 2025 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066094
