UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057201 |
|---|---|
| Receipt number | R000065382 |
| Scientific Title | Evaluation of masticatory muscle function using low-frequency electrical stimulation after maxillofacial surgery |
| Date of disclosure of the study information | 2025/03/05 |
| Last modified on | 2026/03/13 10:33:55 |
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Basic information
Public title
Evaluation of masticatory muscle function using low-frequency electrical stimulation after maxillofacial surgery
Acronym
Evaluation of masticatory muscle function using low-frequency electrical stimulation after maxillofacial surgery
Scientific Title
Evaluation of masticatory muscle function using low-frequency electrical stimulation after maxillofacial surgery
Scientific Title:Acronym
Evaluation of masticatory muscle function using low-frequency electrical stimulation after maxillofacial surgery
Region
| Japan |
Condition
Condition
Jaw deformity
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Early improvement of masticatory function is achieved by applying low-frequency electrical stimulation to the masticatory muscles after maxillofacial surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Low-frequency electrical stimulation will be performed from one week after surgical orthodontic treatment, and it will be evaluated whether there is a difference in the improvement of masticatory function between the group that received continuous low-frequency electrical stimulation for six months and the group that did not.
Key secondary outcomes
Low-frequency electrical stimulation will be performed from one week after surgical orthodontic treatment, and it will be evaluated whether there is a difference in the improvement of sensory function between the group that received continuous low-frequency electrical stimulation for six months and the group that did not.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Group receiving low-frequency electrical stimulation of masticatory muscles after surgical orthodontic treatment
Interventions/Control_2
Group without low-frequency electrical stimulation of masticatory muscles after surgical orthodontic treatment
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
| 16 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 16 years or older who visited Kanagawa Dental University Hospital Orthodontics and Yokohama Clinic Orthodontics and were diagnosed as requiring treatment using maxillofacial surgery were targeted.
Key exclusion criteria
Patients with a history of cleft lip and palate will be excluded.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | So |
| Middle name | |
| Last name | Koizumi |
Organization
Kanagawa Dental University Graduate School
Division name
Orthodontics course
Zip code
238-8580
Address
82 Inaoka-cho, Yokosuka City, Kanagawa Prefecture
TEL
046-822-8813
koizumi@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Shuuichi |
| Middle name | |
| Last name | Atsuta |
Organization
Kanagawa Dental University Graduate School
Division name
Orthodontics course
Zip code
238-8580
Address
82 Inaoka-cho, Yokosuka City, Kanagawa Prefecture
TEL
046-822-8813
Homepage URL
s.atsuta@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental College
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Dental College
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanagawa Dental University Graduate School
Address
82 Inaoka-cho, Yokosuka City, Kanagawa Prefecture
Tel
046-822-8813
s.atsuta@kdu.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 | 03 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 04 | 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 | 03 | Month | 04 | Day |
Last modified on
| 2026 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065382
