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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014585
Receipt No. R000016554
Scientific Title Effect of Periodontal Treatment on Glucose Metabolism among middle-aged men and women (Randamized Controled Trial)
Date of disclosure of the study information 2014/07/17
Last modified on 2016/07/19

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Basic information
Public title Effect of Periodontal Treatment on Glucose Metabolism among middle-aged men and women (Randamized Controled Trial)
Acronym Effect of Periodontal Treatment on Glucose Metabolism
Scientific Title Effect of Periodontal Treatment on Glucose Metabolism among middle-aged men and women (Randamized Controled Trial)
Scientific Title:Acronym Effect of Periodontal Treatment on Glucose Metabolism
Region
Japan

Condition
Condition Borderline diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the impact of periodontal treatment on impaired glucose tolerance using a randomized controlled trial.

Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HOMA-IR
Matsuda Index
Key secondary outcomes Bleeding on probing
Mean pocket depth

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Periodontal treatment ->
no treatment
Interventions/Control_2 no treatment ->
Periodontal treatment
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
30 years-old <=
Age-upper limit
79 years-old >=
Gender Male and Female
Key inclusion criteria Borderline diabetes
(Participants without normal and Diabetes mellitus)
Key exclusion criteria Normal(Fasting blood glucose level <110mg/dl and 2-hours75g oral glucose tolerance test(OGTT)<140 mg/dl)

Diabetes mellitus(Fasting blood glucose level>=126mg/dl or 2-hours75gOGTT>=200 mg/dl)


Target sample size 100

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Isao Saito
Organization Ehime University Graduate School of Medicine
Division name Department of Basic Nursing and Health Science
Zip code
Address Shitsukawa,Toon,Ehime
TEL 089-960-5403
Email saitoi@m.ehime-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Isao Saito
Organization Ehime University Graduate School of Medicine
Division name Department of Basic Nursing and Health Science
Zip code
Address Shitsukawa,Toon,Ehime
TEL 089-960-5403
Homepage URL
Email saitoi@m.ehime-u.ac.jp

Sponsor
Institute Ehime University Graduate School of Medicine
Institute
Department

Funding Source
Organization Meiji Yasuda Life Foundation of Health and Welfare
Organization
Division
Category of Funding Organization Non profit foundation
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
2014 Year 07 Month 17 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 No longer recruiting
Date of protocol fixation
2011 Year 08 Month 26 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 13 Day
Last follow-up date
Date of closure to data entry
2014 Year 03 Month 01 Day
Date trial data considered complete
Date analysis concluded
2015 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2014 Year 07 Month 17 Day
Last modified on
2016 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016554

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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