UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053511 |
|---|---|
| Receipt number | R000061074 |
| Scientific Title | Development of an intraoral device for measuring salivary pH and improvements of measurement accuracy |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/02/01 14:49:53 |
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Basic information
Public title
Development of an intraoral device for measuring salivary pH and improvements of measurement accuracy
Acronym
Development of a device for measuring salivary pH
Scientific Title
Development of an intraoral device for measuring salivary pH and improvements of measurement accuracy
Scientific Title:Acronym
Development of a device for measuring salivary pH
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Dental medicine | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development and improvement of Intraoral device for measuring real-time salivary pH
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary pH (before, during, immediately after, 30 minutes after, 60 minutes after exercise + continuous measurement)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Experiments will be performed on the healthy persons 18 years old or older (adult)
Fully dentate
Key exclusion criteria
People who have infection, medication, salivary gland diseases, dry mouth, oral diseases, undergoing orthodontic treatment, and dentures
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | CHUREI |
Organization
Tokyo Medical and Dental University
Division name
Graduate School of Medical and Dental Sciences Department of Masticatory Function and Health Science
Zip code
113-8549
Address
1-5-45 Yushima Bunkyo-ku, TOKYO
TEL
0358035520
chu.spmd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | CHUREI |
Organization
Tokyo Medical and Dental University
Division name
Graduate School of Medical and Dental Sciences Department of Masticatory Function and Health Science
Zip code
113-8549
Address
1-5-45 Yushima Bunkyo-ku, Tokyo
TEL
0358035520
Homepage URL
chu.spmd@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Self Funding
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
Tokyo Medical and Dental University, Bioethics Research Center
Address
1-5-45 Yushima Bunkyo-ku, Tokyo
Tel
03-5803-7120
info.bec@tmd.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
| 2024 | Year | 04 | 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
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Experiment Prodcedure
Measure salivary pH using mouthguard pH sensor and pH meter. Experiment will be conducted on three days.
On the first day, personal information like Body weight, Height, Heart rate and BMI will be recorded, and baseline data (salivary pH, buffering capacity and flow rate at least 2 h after the last meal or at least one hour after tooth brushing) will be measured using pH meter.
For collection of saliva on Day 1, subjects need to chew unflavored Paraffin wax for 30 seconds and saliva will be collected 3 mins into a container, and we will measure salivary pH, buffering capacity with handheld pocket meter (LAQUAtwin, Horiba Ltd., Tokyo, Japan).
On the second day and third day, experiment will last nearly one and half hours. Subjects need to do ergometer exercise with moderate intensity for 30 mins including warm-up and warm-down exercises. Subjects need to wear a mouthguard pH sensor and earlobe sensor measuring heart rate during the experiment. Rehydration (water and sport drink) 600ml will be given during exercise and rehydration will be four times during experiment. Saliva collection will be done for pH meter measurement before rehydration, before exercise, just after exercise, 30mins after exercise, 60 mins after exercise. Real-time salivary pH will be recorded by the mouthguard sensor, and we will also record the salivary pH values on pH meter before rehydration, before exercise, just after exercise, 30 mins after exercise and 60 mins after exercise.
Management information
Registered date
| 2024 | Year | 02 | Month | 01 | Day |
Last modified on
| 2024 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061074
| Research Plan | |
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