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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000004414
Receipt No. R000005273
Scientific Title Cross sectional study for comparison of oral malodor and oral microflora between diabetes and non-diabetes.
Date of disclosure of the study information 2010/11/01
Last modified on 2011/04/19

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Basic information
Public title Cross sectional study for comparison of oral malodor and oral microflora between diabetes and non-diabetes.
Acronym Study of oral malodor and oral microflora in type 2 diabetes.
Scientific Title Cross sectional study for comparison of oral malodor and oral microflora between diabetes and non-diabetes.
Scientific Title:Acronym Study of oral malodor and oral microflora in type 2 diabetes.
Region
Japan

Condition
Condition Type 2 diabetes mellitus
Classification by specialty
Medicine in general Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is to evaluate difference of breath contents and oral microflora by comparing those between diabetes and non-diabetes. If certain breath contents and oral microflora are found to be specific for diabetes, additional examination is conducted whether these breath contents are caused by the microflora additionally.
Basic objectives2 Others
Basic objectives -Others This study is observation study
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Breath contents, salivary microflora, tongue coating microflora
Key secondary outcomes Oral examination (remaining teeth, PD, CAL, PI, BOP, DMFT, stimulated salivary volume, wearing denture or not, tongue coating score), HbA1c, fasting blood glucose, suffering period from DM, DM therapy, DM complications, smoking, alcohol, BMI, and medications.

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
35 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Type 2 diabetes mellitus
Those who can be obtained informed consent by subjects themselves.
Key exclusion criteria Those who are less than 35 years old
Those who suffer severe disease other than type 2 DM
Those who took antibiotics within 3 months
Those who took periodontal therapy within 6 months
Those who have remaining teeth less than 15
Those who are judged not eligible for the study subjects by their investigators
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Muneo Tanaka
Organization Osaka University Dental Hospital
Division name Department of Preventive Dentistry
Zip code
Address 1-8, Yamadaoka, Suita, Osaka, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Muneo Tanaka
Organization Osaka University Dental Hospital
Division name Department of Preventive Dentistry
Zip code
Address 1-8, Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-2922
Homepage URL
Email

Sponsor
Institute Osaka University Dental Hospital Department of Preventive Dentistry
Institute
Department

Funding Source
Organization Sunstar Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Sunstar Inc.
Name of secondary funder(s) None

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 大阪大学歯学部附属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2010 Year 11 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 Preinitiation
Date of protocol fixation
2010 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
2011 Year 04 Month 01 Day
Date of closure to data entry
2011 Year 05 Month 01 Day
Date trial data considered complete
2011 Year 06 Month 01 Day
Date analysis concluded
2011 Year 07 Month 01 Day

Other
Other related information Cross-sectional study, Random sampling

Management information
Registered date
2010 Year 10 Month 19 Day
Last modified on
2011 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005273

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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