UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017584
Receipt number 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 14:05:30

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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 or person

Institute

Nihon university school of dentistry of matsudo

Institute

Department

Personal name



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

Value
https://center6.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