UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008974 |
|---|---|
| Receipt number | R000010292 |
| Scientific Title | The relationship between oral sensitivity to spice, tactile and heat thresholds and SNP (Single Nucleotide Polymorphism) in patients complaining of oral pain |
| Date of disclosure of the study information | 2012/10/01 |
| Last modified on | 2017/11/10 14:06:24 |
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Basic information
Public title
The relationship between oral sensitivity to spice, tactile and heat thresholds and SNP (Single Nucleotide Polymorphism) in patients complaining of oral pain
Acronym
The relationship between sensitivity to spice, tactile and heat threshold and SNP
Scientific Title
The relationship between oral sensitivity to spice, tactile and heat thresholds and SNP (Single Nucleotide Polymorphism) in patients complaining of oral pain
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yoshihide Mori |
Organization
Graduate School of Dental Science, Kyushu University
Division name
Department of Oral and Maxillofacial Surgery
Zip code
Address
MAIDASHI 3-1-1,HIGASHI-KU FUKUOKA, 812-8582 JAPAN
TEL
092-642-6452
y-mori@dent.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukiko Ohyama |
Organization
Graduate School of Dental Science, Kyushu University
Division name
Department of Oral and Maxillofacial Surgery
Zip code
Address
MAIDASHI 3-1-1,HIGASHI-KU FUKUOKA, 812-8582 JAPAN
TEL
092-642-6452
Homepage URL
yuki@dent.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2012 | Year | 09 | Month | 01 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010292
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
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