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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038853
Receipt No. R000044304
Scientific Title The Study of relationship between inclusive analyzing and clinical diagnosis on orofacial pain patients.
Date of disclosure of the study information 2019/12/11
Last modified on 2019/12/11

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Basic information
Public title The Study of relationship between inclusive analyzing and clinical diagnosis on orofacial pain patients.
Acronym The Study of relationship between inclusive analyzing and clinical diagnosis on orofacial pain patients.
Scientific Title The Study of relationship between inclusive analyzing and clinical diagnosis on orofacial pain patients.
Scientific Title:Acronym The Study of relationship between inclusive analyzing and clinical diagnosis on orofacial pain patients.
Region
Japan

Condition
Condition Orofacial Pain
Classification by specialty
Orthopedics Anesthesiology Oral surgery
Neurosurgery Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To provide the evaluation the contributing factors to a diagnosis and effective treatment for the orofacal pain patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes the evaluation the contributing factors of orofacial pain
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)the patients who are diagnosed as Orofacial pain
(2)the patients who understand and agree the aim of this study.
(3)the patients who is 20 years old and more.
Key exclusion criteria (1)the patients who disagree the aim of this study.
(2)the patients who have the painful diseases excluding orofacial pain.
(3)the patients who are decided as excluding patients by observers.
Target sample size 600

Research contact person
Name of lead principal investigator
1st name Eiji
Middle name
Last name Sakamoto
Organization Kyushu University Faculty of Dental Science
Division name Department of Dental Anesthesiology
Zip code 8128583
Address Maidashi 3-1-1 Higashiku Fukuoka, Fukuoka JAPAN
TEL 092-642-6478
Email esakamto@dent.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Eiji
Middle name
Last name Sakamoto
Organization Kyushu University Faculty of Dental Science
Division name Department of Dental Anesthesiology
Zip code 8128583
Address Maidashi 3-1-1 Higashiku Fukuoka, Fukuoka JAPAN
TEL 092-642-6478
Homepage URL
Email esakamto@dent.kyushu-u.ac.jp

Sponsor
Institute Department of Dental Anesthesiology
Kyushu University Faculty of Dental Science
Institute
Department

Funding Source
Organization Department of Dental Anesthesiology
Kyushu University Faculty of Dental Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Department of Dental Anesthesiology Kyushu University Faculty of Dental Science
Address Maidashi 3-1-1 Higashiku Fukuoka, Fukuoka JAPAN
Tel 092-642-6478
Email esakamto@dent.kyushu-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 九州大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2019 Year 12 Month 11 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 Open public recruiting
Date of protocol fixation
2017 Year 06 Month 26 Day
Date of IRB
2017 Year 06 Month 26 Day
Anticipated trial start date
2017 Year 06 Month 26 Day
Last follow-up date
2022 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To evaluate the contributing factors of Orofacial pain form medical interview and subject and objective findings

Management information
Registered date
2019 Year 12 Month 11 Day
Last modified on
2019 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044304

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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