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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000017584
Receipt No. R000019397
Scientific Title Effect of blood sugar level and hemogulobinA1c on perception threshold of the oral mucosa in diabetes
Date of disclosure of the study information 2015/05/31
Last modified on 2015/05/15

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Basic information
Public title Effect of blood sugar level and hemogulobinA1c on perception threshold of the oral mucosa in diabetes
Acronym Blood sugar level,hemogulobinA1c and the perception threshold
Scientific Title Effect of blood sugar level and hemogulobinA1c on perception threshold of the oral mucosa in diabetes
Scientific Title:Acronym Blood sugar level,hemogulobinA1c and the perception threshold
Region
Japan

Condition
Condition diabetes
Classification by specialty
Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The diabetic induces peripheral neuropathy, however it is not well known how perception of oral cavity is affected ry diabetic. Therefore We perform a study to evaluate blood sugar level and hemogulobinA1c and a perception threshold.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes current perception threshold
perception threshol test
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 male and female 20 years older
Key exclusion criteria hemorrhagic diathesis,Pacemaker,the pregnant,The person who cannot read and write
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kimoto suguru
Organization Nihon university school of dentistry of matsudo
Division name Removable-prosthodontics
Zip code
Address Sakaechonishi, Matsudo-shi, Chiba2-870-1
TEL 047-360-9375
Email kimoto.suguru@nihon-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ogawa takahiro
Organization Nihon university school of dentistry of matsudo
Division name Removable-prosthodontics
Zip code
Address Sakaechonishi, Matsudo-shi, Chiba2-870-1
TEL 047-360-9375
Homepage URL
Email mata14007@nihon-u.ac.jp

Sponsor
Institute Nihon university school of dentistry of matsudo
Institute
Department

Funding Source
Organization Nihon university school of dentistry of matsudo
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 05 Month 31 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 Preinitiation
Date of protocol fixation
2015 Year 02 Month 27 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We measure blood sugar level and hemoglobin A1c of the adult. Furthermore, I measure CPT,PTT in the oral cavity and hand.We compare them.

Management information
Registered date
2015 Year 05 Month 15 Day
Last modified on
2015 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019397

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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