UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004414 |
|---|---|
| Receipt number | 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 17:17:10 |
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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
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
Sponsor or person
Institute
Osaka University Dental Hospital Department of Preventive Dentistry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005273
