UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Periodontal Treatment on Glucose Metabolism among middle-aged men and women (Randamized Controled Trial)
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Name of lead principal investigator	Isao Saito
Organization	Ehime University Graduate School of Medicine
Division name	Department of Basic Nursing and Health Science
Address	Shitsukawa,Toon,Ehime
TEL	089-960-5403
Email	saitoi@m.ehime-u.ac.jp

Public contact
Name of contact person	Isao Saito
Organization	Ehime University Graduate School of Medicine
Division name	Department of Basic Nursing and Health Science
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2011 Year 08 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000016554