UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056573 |
|---|---|
| Receipt number | R000062607 |
| Scientific Title | Usability evaluation of toothpaste containing hinokitiol |
| Date of disclosure of the study information | 2024/12/27 |
| Last modified on | 2024/12/26 10:47:48 |
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Basic information
Public title
Usability evaluation of toothpaste containing hinokitiol
Acronym
Usability evaluation of toothpaste containing hinokitiol
Scientific Title
Usability evaluation of toothpaste containing hinokitiol
Scientific Title:Acronym
Usability evaluation of toothpaste containing hinokitiol
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Usability evaluation of dentifrice containing hinokitiol
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire evaluation after using toothpaste
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Use the test product P for two weeks and evaluate the usability, and then use the test product Q for two weeks and evaluate the usability.
Interventions/Control_2
Use the test product Q for two weeks and evaluate the usability, and then use the test product P for two weeks and evaluate the usability.
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) Healthy men and women aged 20 years or older
(2) Persons who regularly use toothpaste sold by Kobayashi Pharmaceutical Co., Ltd.
(trade name: Syouyo d)
Key exclusion criteria
(1)Those who do not intend to use the test product more than once a day
(2)Persons with drug sensitivities such as allergies
(3)Those who have five major diseases (cancer, stroke, acute myocardial infarction, diabetes, mental illness), etc. and are undergoing treatment at a medical institution or are planning surgery, etc.
(4)Pregnant women, those who may be pregnant, or those who are breastfeeding.
(5)Those who have taken antibiotics within the past month
(6)Those who have had a tooth extracted or surgery for periodontal disease within the past year
(7)Those who are currently attending a dental clinic and receiving oral treatment
(8)Those who wear complete dentures
(9)Persons with obvious trauma in the oral cavity
(10)Those with severe gingival inflammation
(11)Those who are judged to be unsuitable as trial and research participants by the trial doctor or trial and research director
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yasuharu |
| Middle name | |
| Last name | Tamura |
Organization
Asahigaoka Dentalclinic
Division name
Director
Zip code
563-0022
Address
2-10-2, Asahigaoka, Ikeda-shi, Osaka, 563-0022, JAPAN
TEL
+81-72-762-9888
ymtamura@gmail.com
Public contact
Name of contact person
| 1st name | Subaru |
| Middle name | |
| Last name | Hashimoto |
Organization
Kobayashi Pharmaceutical Co., Ltd.
Division name
Oral Care Products R&D Group, Oral Care Products Department, Healthcare Products Headquarters
Zip code
567-0057
Address
1-30-3, Toyokawa, Ibaraki, Osaka, JAPAN
TEL
+81-80-3080-6049
Homepage URL
su.hashimoto@kobayashi.co.jp
Sponsor or person
Institute
Kobayashi Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kobayashi Pharmaceutical 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
SOUKEN Co., Ltd.
Address
1-9-10-3F, Hamamatsu-cho, Minato-ku, Tokyo, JAPAN
Tel
03-5408-1555
y_huzita@mail.souken-r.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 27 | 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
66
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
Completed
Date of protocol fixation
| 2024 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 07 | 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
| 2024 | Year | 12 | Month | 26 | Day |
Last modified on
| 2024 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062607
