UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038853
Receipt number 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 16:22:21

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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 or person

Institute

Department of Dental Anesthesiology
Kyushu University Faculty of Dental Science

Institute

Department

Personal name



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

Value
https://center6.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