UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040942 |
|---|---|
| Receipt number | R000046742 |
| Scientific Title | Effects of occlusal habit on pain sensitivityand occlusal dysesthesia |
| Date of disclosure of the study information | 2020/07/07 |
| Last modified on | 2020/06/29 11:58:43 |
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Basic information
Public title
Effects of occlusal habit on pain sensitivityand occlusal dysesthesia
Acronym
Relationship between occlusal habit and pain
Scientific Title
Effects of occlusal habit on pain sensitivityand occlusal dysesthesia
Scientific Title:Acronym
Effects of occlusal habit on pain sensitivity
Region
| Japan |
Condition
Condition
Temporomandibular disorder
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of interaction between eccentric exercise and clenching exercise on pain sensitivity
Basic objectives2
Others
Basic objectives -Others
To examine the effects of preloading eccentric exercise on pain sensitivity after clenching exercise
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain intensity induced by electrical stimuli using visual analog scale (VAS):before and after each exercise
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
eccentric exercise performed using a jaw opening device and voluntary clenching exercise
Interventions/Control_2
gum chewing exercise and voluntary clenching exercise
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy adult volunteers
Key exclusion criteria
symptoms of temporomandibular disorder, neurological disorders or abnormalities in stomatognatic, neck and shoulder function, daily headache, awareness of bruxism, functional pain or pain by palpation in the muscles of the orofacial region or temporomandibular joint, use of pain medicine within 1 month
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tetsurou |
| Middle name | |
| Last name | Torisu |
Organization
Nagasaki University
Division name
Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences
Zip code
8528588
Address
1-7-1 Sakamoto, Nagasaki
TEL
0958197692
torisu@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsurou |
| Middle name | |
| Last name | Torisu |
Organization
Nagasaki University
Division name
Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences
Zip code
8528588
Address
1-7-1 Sakamoto, Nagasaki
TEL
0958197692
Homepage URL
torisu@nagasaki-u.ac.jp
Sponsor or person
Institute
Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences, Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
1.Department of Oral Health Sciences, KU Leuven,Belgium
2.Section of Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethics committee of Nagasaki University Graduate School of Medicine and Dentistry
Address
1-7-1, Sakamoto, Nagasaki
Tel
0958197229
gaibushikin@ml.nagasaki-u.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
| 2020 | Year | 07 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1007/s10266-020-00516-w
Number of participants that the trial has enrolled
20
Results
The degree of temporal summation of pain after clenching induced by repeated electrical stimulation to the masseter muscle showed statistically significant increases 2 days after the exercise only in the eccentric condition of the preloading exercises but not in the gum chewing condition.
It was demonstrated that pain sensitivity after the low-level clenching could be influenced by the type of the preloading exercise.
Results date posted
| 2020 | Year | 06 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 04 | Month | 09 | Day |
Baseline Characteristics
Participant flow
Adverse events
non
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 01 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 29 | Day |
Last modified on
| 2020 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046742
