UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059129 |
|---|---|
| Receipt number | R000067640 |
| Scientific Title | Clinical efficacy study of continuous use of dentifrice NW372 on oral condition |
| Date of disclosure of the study information | 2025/09/30 |
| Last modified on | 2025/09/18 22:26:02 |
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Basic information
Public title
Efficacy test of the dentifrice
Acronym
Efficacy test of the dentifrice
Scientific Title
Clinical efficacy study of continuous use of dentifrice NW372 on oral condition
Scientific Title:Acronym
Efficacy test of the dentifrice
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the oral benefits of continuous use of dentifrice NW372.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of gingival condition before and after 6 months of dentifrice use
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Use dentifrice NW372 at least twice a day for 6 months
Interventions/Control_2
Use control dentifrice at least twice a day for 6 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
| 18 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Males and females aged 18 to 79 years.
2.Patients receiving regular dental check-ups at Kanagawa Dental University Hospital and staff members of Kanagawa Dental University Hospital.
3.Subjects with gingival recession without inflammation in the maxillary and mandibular central incisors and lateral incisors, exhibiting minimal dental misalignment.
4.Subjects who can use toothpaste in amounts of at least 1 gram and brush their teeth for a minimum of 2 minutes, twice a day.
5.Subjects who agree to use only the specified toothpaste and toothbrush during the trial period (interdental brushes and dental floss are allowed, but the use of other toothpastes, mouthwashes, and liquid toothpastes is not permitted).
6.Subjects with no smoking habits.
7.Subjects who can discontinue high-concentration fluoride applications during the trial period.
Key exclusion criteria
1.Subjects with implants, dentures (false teeth), crowns, fillings near the gingival margin, or root surface caries on the target teeth.
2.Subjects who have undergone periodontal regenerative treatment within the past 6 months.
3.Subjects with smoking habits.
4.Subjects who are already participating in other research at the time of receiving an explanation of the research, or who are scheduled to participate in other research during the period of cooperation for participation in this study.
5.Subjects deemed ineligible based on the diagnosis of a dentist.
6.Subjects who are deemed inappropriate for participation in the study by the principal investigator or research staff due to other reasons, including noncompliance with study obligations.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Motohiro |
| Middle name | |
| Last name | Komaki |
Organization
Kanagawa Dental University
Division name
Department of Periodontology
Zip code
238-8580
Address
82, Inaoka-cho, Yokosuka, Kanagawa, 238-8580, JAPAN
TEL
0468453161
m.komaki@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Shuntaro |
| Middle name | |
| Last name | Sugihara |
Organization
Kanagawa Dental University
Division name
Department of Periodontology
Zip code
238-8580
Address
82, Inaoka-cho, Yokosuka, Kanagawa, 238-8580, JAPAN
TEL
0468453161
Homepage URL
sugihara@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Kanagawa Dental College Research Ethics Review Committee
Address
82, Inaoka-cho, Yokosuka, Kanagawa, 238-8580, JAPAN
Tel
046-822-8813
kenkyo@kdu.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 | 09 | 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 | 06 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | 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 | 09 | Month | 18 | Day |
Last modified on
| 2025 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067640
