UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059918 |
|---|---|
| Receipt number | R000068477 |
| Scientific Title | Effect of different splint materials on biological responses |
| Date of disclosure of the study information | 2025/11/28 |
| Last modified on | 2025/11/28 18:55:49 |
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Basic information
Public title
Comparison of the effect of three types of oral appliance during experimental bruxism on the masseter muscle
Acronym
Effects of Oral Appliances on the Masseter Muscle
Scientific Title
Effect of different splint materials on biological responses
Scientific Title:Acronym
Effect of splint use on biological responses
Region
| Japan |
Condition
Condition
Bruxism
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to clarify the differences in physiological effects of two types of jaw movements-clenching and grinding-performed experimentally during wakefulness in healthy adults, focusing on tissue oxygenation of the masticatory muscles, muscle fatigue, and autonomic nervous system activity. Furthermore, by combining three types of oral appliances (hard-type, soft-type, and combi-type) with a non-appliance condition, this study aims to examine how these appliances influence physiological responses under each condition and to compare subjective evaluations, thereby elucidating the effects of oral appliance use on the body and the differences arising from material characteristics.
Basic objectives2
Others
Basic objectives -Others
An exploratory study aimed at elucidating the physiological mechanisms underlying the effects of clenching, grinding, and the use of various oral appliances on biological parameters.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in tissue oxygen saturation (StO2) of the masseter muscles during experimental clenching and grinding tasks. StO2 is evaluated as the difference from the 4-min pre-task baseline mean to the minimum value and recovery course during the 30-s jaw movement and the subsequent 4-min recovery period, with comparisons between jaw-movement types (clenching vs. grinding) and oral appliance conditions (no appliance, hard, soft, and combi).
Key secondary outcomes
Changes in other tissue oxygenation parameters of the masseter muscles (oxyhemoglobin, deoxyhemoglobin, total hemoglobin), defined as differences from the 4-min pre-task baseline mean during the 30-s task and the 4-min post-task recovery period.
Masseter muscle activity assessed by surface electromyography (RMS and %MVC), comparing the pre-task baseline with the 30-s task period.
Subjective fatigue levels evaluated using a visual analogue scale (VAS) immediately after each task.
Subjective evaluations related to oral appliance use, including wearing comfort and perceived ease of clenching and grinding for each appliance condition, assessed by VAS after each task.
Heart rate and heart rate variability indices (HR, CVRR, ccvHF, LF/HF), comparing the 4-min pre-task baseline with the 30-s task period and the 4-min post-task recovery period.
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
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Healthy adult participants perform experimental jaw-movement tasks in a laboratory setting. Under four oral appliance conditions (no appliance, hard-type appliance, soft-type appliance and combi-type appliance) applied in random order, each participant performs clenching and grinding tasks. In the clenching task, participants are instructed to perform maximal voluntary clenching for 30 seconds. In the grinding task, they perform maximal voluntary grinding at 1 Hz for 30 seconds. Near-infrared spectroscopy of the masseter muscles (tissue oxygenation), surface electromyography and heart rate variability are recorded during the 4-minute pre-task baseline, the 30-second task period and the 4-minute post-task recovery period. Immediately after each task, subjective fatigue and appliance-related evaluations are assessed using a visual analogue scale. All tasks are completed in a single visit with sufficient rest periods between tasks.
This study employs a within-subjects (cross-over) design in which all participants complete all four conditions (no appliance, hard-type, soft-type, and combi-type).
Although the order of conditions is randomized for each participant, there is no group allocation; therefore, the study is registered as "non-randomized" in the UMIN system.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Having at least 28 teeth
No subjective or objective abnormalities in the oral cavity, temporomandibular joint, or craniocervical muscles
No history of neurosurgical diseases
Key exclusion criteria
Taking medications that may affect psychological or cardiovascular systems
Having signs or symptoms of temporomandibular disorders (TMD) in screening tests
History of neurosurgical diseases
Considered unsuitable for participation by the investigators
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Ken-ichi |
| Middle name | |
| Last name | Fukuda |
Organization
Tokyo Dental College
Division name
Division of Special Needs Dentistry and Orofacial Pain, Department of Oral Health and Clinical Science
Zip code
101-0061
Address
2-9-18 Kandamisakicho, Chiyoda-ku, Tokyo
TEL
03-5275-1582
kfukuda@tdc.ac.jp
Public contact
Name of contact person
| 1st name | Yuichiro |
| Middle name | |
| Last name | Ohta |
Organization
Tokyo Dental College
Division name
Division of Special Needs Dentistry and Orofacial Pain, Department of Oral Health and Clinical Scien
Zip code
101-0061
Address
2-9-18 Kandamisakicho, Chiyoda-ku, Tokyo
TEL
03-5275-1582
Homepage URL
ootayuuichirou@tdc.ac.jp
Sponsor or person
Institute
Tokyo Dental College
Institute
Department
Personal name
Funding Source
Organization
None
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
Tokyo Dental College
Address
2-9-18 Kandamisakicho, Chiyoda-ku, Tokyo
Tel
03-6380-9114
drinri@tdc.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 | 11 | 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
18
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
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 10 | 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
Management information
Registered date
| 2025 | Year | 11 | Month | 28 | Day |
Last modified on
| 2025 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068477
