UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056797 |
|---|---|
| Receipt number | R000064891 |
| Scientific Title | Measurement of salivary pH while consuming non-cariogenic food with aligner. - pre-post comparison test- |
| Date of disclosure of the study information | 2025/02/28 |
| Last modified on | 2025/07/24 10:22:14 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Measurement of salivary pH while consuming test food
Acronym
Measurement of salivary pH
Scientific Title
Measurement of salivary pH while consuming non-cariogenic food with aligner. - pre-post comparison test-
Scientific Title:Acronym
Measurement of salivary pH
Region
| Japan |
Condition
Condition
Healty adult
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of the test food on salivary pH in healthy subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
salivary pH
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of the test food
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
| 20 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Males and females whose age is between 20 and 64 years old
2)Aligner orthodontics patient
3)Subjects who don't eat and drink except water for an hour before study
Key exclusion criteria
1)Female subjects who are pregnant or lactating, or intending to become pregnant during the study
2)Subjects who have a fever or complain of illness
3)Subjects who eat and drink except water for an hour before study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Matsuoka |
Organization
Health Art Planning Co., Ltd.
Division name
Dentist
Zip code
158-0082
Address
3-29-18, Todoroki Setagaya-ku, Tokyo
TEL
03-5755-5115
info@health-ap.com
Public contact
Name of contact person
| 1st name | Toshiko |
| Middle name | |
| Last name | Matsuoka |
Organization
Health Art Planning Co., Ltd.
Division name
Representative director
Zip code
158-0082
Address
3-29-18, Todoroki Setagaya-ku, Tokyo
TEL
03-5755-5115
Homepage URL
info@health-ap.com
Sponsor or person
Institute
Mitsui DM Sugar Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute for Health Restoration Co., Ltd.
Address
416-101 Mushakoji-cho, Kamigyo-ku, Kyoto-shi
Tel
075-366-8309
mori@kenkousaisei.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
| 2025 | Year | 02 | Month | 28 | 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
Completed
Date of protocol fixation
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 07 | Month | 24 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 23 | Day |
Last modified on
| 2025 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064891
