UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058073 |
|---|---|
| Receipt number | R000066372 |
| Scientific Title | The Relationship Between Exercise-Induced Clenching and Sleep Bruxism in Continuously Trained and Untrained Individuals: Influence of Exercise Intensity and Temporal Variation |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/06/03 19:09:28 |
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Basic information
Public title
Elucidation of the relationship between exercise-induced clenching and sleep bruxism
Acronym
Relationship between clenching during exercise and bruxism during sleep
Scientific Title
The Relationship Between Exercise-Induced Clenching and Sleep Bruxism in Continuously Trained and Untrained Individuals: Influence of Exercise Intensity and Temporal Variation
Scientific Title:Acronym
Elucidation of the relationship between exercise-induced clenching and sleep bruxism: Influence of Exercise Intensity and Temporal Variation
Region
| Japan |
Condition
Condition
Exercise-Induced Clenching and Sleep Bruxism
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to compare clenching activity during exercise and the degree of sleep bruxism following low and high-intensity exercise sessions using surface electromyography (EMG). Participants will be divided into two groups: continuously trained and untrained. The masseter muscle activity will be monitored during exercise and sleep across a time course, which will evaluate the expression relationship between sleep and exercise and between-group differences (continuously trained and untrained).
Basic objectives2
Others
Basic objectives -Others
Clenching during exercise and sleep bruxism can negatively affect the teeth and surrounding oral structures, leading to tooth wear, muscle pain, and joint issues.
Understanding the relationship between these two behaviors, especially how clenching during exercise may influence sleep bruxism, can help us develop effective preventive strategies.
By identifying individuals at higher risk, appropriate protective measures such as wearing a mouthguard during training and a nightguard during sleep can be recommended to reduce damage and protect oral health.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of sleep bruxism intensity
1) Day before, on the day of, and the day after the prescribed exercise (low intensity)
2) Day before, on the day of, and the day after the prescribed exercise (high intensity)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
As for low-intensity weightlifting, Participants will perform weightlifting at 40% of 1RM, consisting of 1 set of 30 repetitions followed by 3 sets of 15 repetitions, with 60 seconds of rest between sets.
As for the high-intensity weightlifting, Participants will perform weightlifting at 70% of 1RM, 3 sets followed by 8 repetitions with 1.5 minutes of rest between each set.
1. 45degree Half Squat
2. Bench Press
3. Leg Curl
4. Rowing
5. Unilateral Leg Extension
Interventions/Control_2
As for low-intensity weightlifting, Participants will perform weightlifting at 40% of 1RM, consisting of 1 set of 30 repetitions followed by 3 sets of 15 repetitions, with 60 seconds of rest between sets.
As for the high-intensity weightlifting, Participants will perform weightlifting at 70% of 1RM, 3 sets followed by 8 repetitions with 1.5 minutes of rest between each set.
1. 45degree Half Squat
2. Bench Press
3. Leg Curl
4. Rowing
5. Unilateral Leg Extension
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Continuously Trained and Untrained Individuals
Key exclusion criteria
People who have
1) Wearing a removable denture
2) Lack of any occlusal support zone due to tooth loss in the molar region
3) Current use of muscle relaxants, anti-inflammatory medicines
4) Presence of any advanced periodontal disease
5) Chronic orofacial pain or a history of neurological or psychiatric disorders
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | CHUREI |
Organization
Institute of Science Tokyo
Division name
Outpatient for Sports Dentistry, Institute of Science Tokyo Hospital
Zip code
1138549
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
0358034891
chu.spmd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | CHUREI |
Organization
Institute of Science Tokyo
Division name
Outpatient for Sports Dentistry, Institute of Science Tokyo Hospital
Zip code
1138549
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
0358034891
Homepage URL
chu.spmd@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Institute of Science Tokyo
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
Outpatient for Sports Dentistry, Institute of Science Tokyo Hospital
Address
1-5-45 Yushima Bunkyo-ku Tokyo, JAPAN
Tel
0358034891
chu.spmd@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
| 2025 | Year | 08 | 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
| 2025 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | 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 | 03 | Day |
Last modified on
| 2025 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066372
