UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042553 |
|---|---|
| Receipt number | R000048572 |
| Scientific Title | The study of the relationship between experimental masticatory movement stimulation and brain-derived neurotrophic factor in healthy subjects |
| Date of disclosure of the study information | 2021/01/26 |
| Last modified on | 2024/11/30 11:08:13 |
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Basic information
Public title
The study of the relationship between experimental masticatory movement stimulation and brain-derived neurotrophic factor in healthy subjects
Acronym
The study of the relationship between experimental masticatory movement stimulation and brain-derived neurotrophic factor in healthy subjects
Scientific Title
The study of the relationship between experimental masticatory movement stimulation and brain-derived neurotrophic factor in healthy subjects
Scientific Title:Acronym
The study of the relationship between experimental masticatory movement stimulation and brain-derived neurotrophic factor in healthy subjects
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether the masticatory movement increase brain-derived neurotrophic factor levels in saliva and blood
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brain-derived neurotrophic factor levels in saliva and blood
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Gum chewing movement to placebo chewing movement
Interventions/Control_2
Placebo chewing movement to gum chewing movement
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
Patient who shows his/her will to participate in this study after obtaining informed consent through the substantial explanation on this investigation
Key exclusion criteria
Patients with systemic disease
Patients taking medication
Patient with smoking
Patients with less than 24 functional teeth
Patients with masticatory disorders
Patients who are judged by investigators as being unsuitable because of other factors
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Takuo |
| Middle name | |
| Last name | Kuboki |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Oral Rehabilitation and Regenerative Medicine
Zip code
700-8558
Address
2-5-1, Shikata-cho,Kita-ku, Okayama, Japan
TEL
0862356682
kuboki@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Mino |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Oral Rehabilitation and Regenerative Medicine
Zip code
700-8558
Address
2-5-1, Shikata-cho,Kita-ku, Okayama, Japan
TEL
0862356682
Homepage URL
gmd20107@s.okayama-u.ac.jp
Sponsor or person
Institute
Department of Oral Rehabilitation and Regenerative Medicine, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan
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
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1, Shikata-cho,Kita-ku, Okayama, Japan
Tel
0862356938
mae6605@adm.okayama-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
| 2021 | Year | 01 | Month | 26 | 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
2
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 | 11 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2024 | 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
| 2020 | Year | 11 | Month | 25 | Day |
Last modified on
| 2024 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048572
