UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059221 |
|---|---|
| Receipt number | R000067737 |
| Scientific Title | Influence of the dental implant on clenching behavior and masticatory muscle pain |
| Date of disclosure of the study information | 2025/10/10 |
| Last modified on | 2025/09/29 12:38:25 |
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Basic information
Public title
Influence of the dental implant on clenching behavior and masticatory muscle pain
Acronym
Influence of the dental implant on clenching behavior and masticatory muscle pain
Scientific Title
Influence of the dental implant on clenching behavior and masticatory muscle pain
Scientific Title:Acronym
Influence of the dental implant on clenching behavior and masticatory muscle pain
Region
| Japan |
Condition
Condition
muscle pain related to the dental implant
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the difference between patients with/without the dental implant of the character of the masticatory muscle activities
Basic objectives2
Others
Basic objectives -Others
To investigate the difference between patients with/without the dental implant of the character of the referred pain
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
muscle stiffness
Key secondary outcomes
pressure pain level, resistance force against jaw opening
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
patients treated with fixed dental implant
control: volunteers without the dental implant treatment
Key exclusion criteria
patients who have antagonistic teeth treated with removable denture
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Tetsurou |
| Middle name | |
| Last name | TORISU |
Organization
Nagasaki University Hospital
Division name
Division of Denture Prosthesis
Zip code
8528588
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
0958197692
torisu@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsurou |
| Middle name | |
| Last name | TORISU |
Organization
Nagasaki University Hospital
Division name
Division of Denture Prosthesis
Zip code
8528588
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
0958197692
Homepage URL
torisu@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital Clinical Research Center
Address
1-7-1 Sakamoto, Nagasaki, Japan
Tel
0958197726
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
| 2025 | Year | 10 | Month | 10 | 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 | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
measurement of muscle stiffness and pain
Management information
Registered date
| 2025 | Year | 09 | Month | 29 | Day |
Last modified on
| 2025 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067737
