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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007670
Receipt No. R000009043
Scientific Title Effect of glycemic control on periodontitis in type 2 diabetic patients with periodontal disease: a pilot study
Date of disclosure of the study information 2012/04/05
Last modified on 2012/04/05

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Basic information
Public title Effect of glycemic control on periodontitis in type 2 diabetic patients with periodontal disease: a pilot study
Acronym Effect of glycemic control on periodontitis in type 2 diabetic patients
Scientific Title Effect of glycemic control on periodontitis in type 2 diabetic patients with periodontal disease: a pilot study
Scientific Title:Acronym Effect of glycemic control on periodontitis in type 2 diabetic patients
Region
Japan

Condition
Condition type 2 diabetes, periodontitis
Classification by specialty
Endocrinology and Metabolism Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of improved glycemic control through glycemic intervention therapy on periodontitis in type 2 diabetic patents.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes probing pocket depth (PPD)
bleeding on probing (BOP)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Food
Interventions/Control_1 dietary counseling, oral hypoglycemic agents, and insulin administration
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
40 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria glycohemoglobin (HbA1c) &#8805;7.0%
no severe diabetic complications
no evidence of systemic disease other than diabetes as a risk factor for periodontitis
Key exclusion criteria pregnancy or lactation
systemic antibiotics during the preceding 3 months
receiving periodontal treatment during the preceding 6 months
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuji Inoue
Organization Kiryu University
Division name Department of Clinical Nutrition, Faculty of Health Care
Zip code
Address 606-7 Azami, Kasakake-cho, Midori-city, Gunma
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tokyo Medical and Dental University
Division name Department of Periodontology
Zip code
Address
TEL 03-5803-5488
Homepage URL
Email

Sponsor
Institute Kiryu University
Institute
Department

Funding Source
Organization Grant-in-Aid from the Ministry of Health, Labour and Welfare of Japan (H16-Iro-020)
Organization
Division
Category of Funding Organization
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
2012 Year 04 Month 05 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2008 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 04 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

Management information
Registered date
2012 Year 04 Month 05 Day
Last modified on
2012 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009043

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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