UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052454 |
|---|---|
| Receipt number | R000059764 |
| Scientific Title | Quantitative Assessment of the Craving Sensation for Toothpaste |
| Date of disclosure of the study information | 2024/10/11 |
| Last modified on | 2023/10/04 17:05:12 |
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Basic information
Public title
Quantitative Assessment of the Craving Sensation for Toothpaste
Acronym
Quantitative Assessment of the Craving Sensation for Toothpaste
Scientific Title
Quantitative Assessment of the Craving Sensation for Toothpaste
Scientific Title:Acronym
Quantitative Assessment of the Craving Sensation for Toothpaste
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To quantitatively assess the characteristics of users who experience a craving sensation for toothpaste, with the aim of gaining valuable insights for future product development and related endeavors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Electroencephalogram (EEG) measurements
Subjective assessment using Visual Analog Scale (VAS)
Questionnaire survey
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Brushing tooth every day, for one week, at individual home using the test product.
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
Is 40 years of age or older.
Has never used "Clean Dental L Total Care".
Has completed the two-dose coronavirus vaccine.
Not using removable dentures or wire orthodontic appliances.
Is not participating in any other trials or studies for medications or foods, or plans to do so during the duration of this study.
Key exclusion criteria
Has systemic diseases that make participation in the trial difficult.
Has underlying conditions related to the gustatory system.
Has a history of allergies to toothpaste.
Is pregnant or breastfeeding.
Undergoing orthodontic treatment.
Smokers
Additionally, individuals deemed unsuitable as study participants by the principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akihito |
| Middle name | |
| Last name | Kikuchi |
Organization
SandBox Inc.
Division name
Chief Executive Officer (CEO) and Representative Director
Zip code
162-0066
Address
B1F, 12-12 Ichigayadaimachi, Shinjuku-ku, Tokyo
TEL
080-4365-4099
info@sandbox-vr.com
Public contact
Name of contact person
| 1st name | Ayumu |
| Middle name | |
| Last name | Manabe |
Organization
Manabe Clinic, Shinai-kai Medical Association
Division name
Director
Zip code
205-0001
Address
2-7-13, Ozakudai, Hamura City, Tokyo
TEL
042-554-6511
Homepage URL
ayumu.m76@gmail.com
Sponsor or person
Institute
SandBox Inc.
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
SandBox Inc Institutional Review Board
Address
2F Nihonbashi Muromachi 162 Building, 6-2, 1-chome, Nihonbashi Muromachi, Chuo-ku, Tokyo
Tel
080-4082-6900
angrargna@gmail.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 | 10 | Month | 11 | 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
| 2023 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 10 | Month | 10 | Day |
Last modified on
| 2023 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059764
