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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024730
Receipt No. 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

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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
Email 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
Email uezato-tmd@umin.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028417

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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