UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058249 |
|---|---|
| Receipt number | R000066586 |
| Scientific Title | The effect of transcutaneous interferential current stimulation of the buccal masseter muscle on masticatory function |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/06/22 13:36:37 |
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Basic information
Public title
The effect of transcutaneous interferential current stimulation of the buccal masseter muscle on masticatory function
Acronym
Effect of electrical cheek stimulation on mastication
Scientific Title
The effect of transcutaneous interferential current stimulation of the buccal masseter muscle on masticatory function
Scientific Title:Acronym
Effect of electrical cheek stimulation on mastication
Region
| Japan |
Condition
Condition
Those who have no underlying diseases that affect chewing function
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will examine whether transcutaneous interferential current stimulation contributes to improving masticatory ability.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of glucose released when chewing gummy jelly
Key secondary outcomes
Subjective assessment of chewing ability (self-assessment using a VAS scale)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The head of a commercially available facial beauty device (Cell Cure DFT, JCraft, Osaka, Japan) is placed between the masseter muscle areas of the left and right cheeks (from the zygomatic process to the angle of the mandible) for 2.5 minutes on one cheek, and 5 minutes on both cheeks in total, and a single IW wave stimulus is applied at a stimulation intensity of level 6 (2.98 mA to 5.96 mA).
Interventions/Control_2
Similarly, place the beauty device on the cheek, but do not apply electricity.
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
| 30 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Adults who have undergone regular checkups at Hara Dental Clinic, Shihokai Medical Corporation
2. Those who do not have any underlying diseases that affect chewing function
3. Those who do not use dentures or only use prosthetic devices with the same functions as natural teeth
4. Those who have not undergone IW treatment or have not undergone IW treatment for more than three months
5. Those who understand the purpose of the study and can sign the consent form
Key exclusion criteria
1. Those who regularly use home beauty devices
2. Those with abnormalities in the masticatory muscles or temporomandibular joint (temporomandibular joint disorder, masseter hypertrophy, etc.)
3. Those who have been diagnosed with xerostomia
4. Those who have difficulty receiving electrical stimulation due to metal allergies or skin diseases
5. Pregnant or breastfeeding women
6. Those who are planning to undergo major dental treatment during the study period
7. Those with pacemakers
8. Those with heart problems or heart diseases
9. Those with bleeding disorders or hemophilia
10. Those with peripheral neuropathy
11. Those with facial neuralgia
12. Other people who the principal investigator deems inappropriate for participation in this study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Hara |
Organization
Hara Dental Clinic
Division name
President
Zip code
480-1118
Address
2203 Yokomichi, Nagakute, Aichi
TEL
0561-62-4181
hara0824@icloud.com
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Hara |
Organization
Hara Dental Clinic
Division name
President
Zip code
480-1118
Address
2203 Yokomichi, Nagakute, Aichi
TEL
0561-62-4181
Homepage URL
hara0824@icloud.com
Sponsor or person
Institute
Hara Dental Clinic
Institute
Department
Personal name
Funding Source
Organization
Hara Dental Clinic
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
Hyogo Medical University
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo
Tel
0798-45-6111
rinri@hyo-med.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 | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2025 | Year | 06 | Month | 22 | Day |
Last modified on
| 2025 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066586
