UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The relationship between oral sensitivity to spice, tactile and heat thresholds and SNP (Single Nucleotide Polymorphism) in patients complaining of oral pain
Title of the study (Brief title)	The relationship between sensitivity to spice, tactile and heat threshold and SNP
Region	Japan

Condition
Condition	Patients complaining of oral pain
Classification by specialty	Oral surgery Dental medicine
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Detection of SNP among patients who complain of oral pain and healthy Japanese, and how SNP relates to oral sensitivity to spice, tactile and heat thresholds.
Basic objectives2	Others
Basic objectives -Others	Detection of sensitivity
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Sensitivity to spice, tactile and heat threshold SNP
Key secondary outcomes	Questionnaire of spice stimuli and eating habit

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Gene Food Device,equipment
Interventions/Control_1	1.The tactile threshold of upper lip 2.The temperature threshold of the tongue and lower lip 3.Measure the VAS of the sensitivity when 55C water is in the mouth 4.Measure the VAS and threshold to capsaicin stimuli of the tongue
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	Japanese Patients who complain of oral pain after giving consent to sensory tests Healthy Japanese who give consent to sensory tests.
Key exclusion criteria	1.People with body temperatures above 38C 2.People who have experienced cerebral strokes, head or neck trauma and resultant operations. 3.People who have experienced trigeminal injury 4.People who suffer from neuropathy or chronic pain as a result from chronic diseases like diabetes or rheumatoid arthritis. 5.People who have dermatological or oral mucosa problems on measuring area 6.People who are pregnant 7.Incompatible people
Target sample size	80

Research contact person
Name of lead principal investigator	Yoshihide Mori
Organization	Graduate School of Dental Science, Kyushu University
Division name	Department of Oral and Maxillofacial Surgery
Address	MAIDASHI 3-1-1,HIGASHI-KU FUKUOKA, 812-8582 JAPAN
TEL	092-642-6452
Email	y-mori@dent.kyushu-u.ac.jp

Public contact
Name of contact person	Yukiko Ohyama
Organization	Graduate School of Dental Science, Kyushu University
Division name	Department of Oral and Maxillofacial Surgery
Address	MAIDASHI 3-1-1,HIGASHI-KU FUKUOKA, 812-8582 JAPAN
TEL	092-642-6452
Homepage URL
Email	yuki@dent.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University Hospital
Institute
Department

Funding Source
Organization	Grant-in-aid Japan Society for the Promotion of Sience
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	JAPAN

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	2012 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 09 Month 01 Day
Anticipated trial start date	2012 Year 09 Month 01 Day
Last follow-up date	2017 Year 06 Month 18 Day
Date of closure to data entry	2017 Year 06 Month 18 Day
Date trial data considered complete	2017 Year 06 Month 18 Day
Date analysis concluded	2018 Year 06 Month 18 Day

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

Management information
Registered date	2012 Year 09 Month 24 Day
Last modified on	2017 Year 11 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010292