UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024730 |
|---|---|
| Receipt number | R000028417 |
| Scientific Title | Observational study of clinical features of the oral discomfort syndrome |
| Date of disclosure of the study information | 2016/11/08 |
| Last modified on | 2018/12/29 11:44:50 |
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Basic information
Public title
Observational study of clinical features of the oral discomfort syndrome
Acronym
Oral discomfort syndrome
Scientific Title
Observational study of clinical features of the oral discomfort syndrome
Scientific Title:Acronym
Oral discomfort syndrome
Region
| Japan |
Condition
Condition
Oral discomfort syndrome
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To perform retrospective study to investigate associations between clinical features of oral discomfort syndrome and results of blood, imaging and psychological tests and response to drug treatments.
Basic objectives2
Others
Basic objectives -Others
To investigate differences in results of blood, imaging and psychological tests between patients with and without oral discomfort syndrome.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical features of patients with oral discomfort syndrome.
Associations between clinical features of oral discomfort syndrome and results of blood, imaging and psychological tests.
Associations between drug profiles and treatment response.
Differences in results of blood, imaging and psychological tests between patients with and without oral discomfort syndrome.
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who consulted the psychiatry clinic for symptoms of oral discomfort syndrome. For the purpose of comparison, patients with other psychiatric diagnosis but without oral discomfort syndrome who underwent blood, imaging or psychological tests.
Key exclusion criteria
Patiens who declare that the information in their medical records are not to be used for the sutudy.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihito Uezato |
Organization
Graduate School of Tokyo Medical and Dental University
Division name
Department of Psychiatry and Behavioral Sciences
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5242
uezato-tmd@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihito Uezato |
Organization
Graduate School of Tokyo Medical and Dental University
Division name
Department of Psychiatry and Behavioral Sciences
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5242
Homepage URL
uezato-tmd@umin.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 11 | Month | 08 | 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
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2016 | Year | 11 | Month | 06 | Day |
Last modified on
| 2018 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028417
