UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031402 |
|---|---|
| Receipt number | R000035840 |
| Scientific Title | Functional neuroimaging study of occlusal sensitivity |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2023/09/26 21:58:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Functional neuroimaging study of occlusal sensitivity
Acronym
Functional neuroimaging study of occlusal sensitivity
Scientific Title
Functional neuroimaging study of occlusal sensitivity
Scientific Title:Acronym
Functional neuroimaging study of occlusal sensitivity
Region
| Japan |
Condition
Condition
Phantom bite syndrome
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To unravel brain mechanism of occlusal sensation
Basic objectives2
Others
Basic objectives -Others
To unravel pathophysiology of phantom bite syndrome
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Distribution of cerebral blood flow
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Brain perfusion single photon emission computed tomography (SPECT) with a bolus injection of 600 MBq of 99mTc-ECD
One time per 1 person
Interventions/Control_2
Brain perfusion single photon emission computed tomography (SPECT) with a bolus injection of 600 MBq of 99mTc-ECD
One time per 1 person
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
Twenty subjects with phantom bite syndrome who visited psychosomatic dentistry clinic, Tokyo Medical and Dental University.
Twenty subjects who have been treated with general dental treatment, visited prosthodontics clinic, Tokyo Medical and Dental University.
Key exclusion criteria
1)HDS-R score less than or equal to 24
2)The subjects with psychiatric and neurological complaints
3)Abnormalities were observed on magnetic resonance image (MRI) of the brain
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Toyofuku |
Organization
Tokyo Medical and Dental University
Division name
Psychosomatic Dentistry, Graduate School of Medical and Dental Sciences
Zip code
113-8549
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5909
toyoompm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Toyofuku |
Organization
Tokyo Medical and Dental University
Division name
Psychosomatic Dentistry, Graduate School of Medical and Dental Sciences
Zip code
113-8549
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5909
Homepage URL
toyoompm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental 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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
Tel
03-5803-5898
toyoompm@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
| 2018 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
40
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
| 2016 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 21 | Day |
Last modified on
| 2023 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035840
