UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observational study of clinical features of the oral discomfort syndrome
Title of the study (Brief title)	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	Akihito Uezato
Organization	Graduate School of Tokyo Medical and Dental University
Division name	Department of Psychiatry and Behavioral Sciences
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	Akihito Uezato
Organization	Graduate School of Tokyo Medical and Dental University
Division name	Department of Psychiatry and Behavioral Sciences
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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