The Relation Between Periodontal Disease and Metabolic Sy... | NCT00553007

Studies
The Relation Between Periodontal Disease and Metabolic Syndrome

NCT00553007

Sponsor

Aichi Gakuin University

Status

Unknown status

Last Update Posted

Nov 2, 2007Estimated

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Periodontal Disease
Metabolic Syndrome

Interventions

Periodontal therapy

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Not provided

Completion Date

Oct 2009Estimated

First Submitted Date

Nov 1, 2007

First Submission Date that Met QC Criteria

Nov 1, 2007

First Posted Date

Nov 2, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2007

Last Update Posted Date

Nov 2, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Periodontal disease is associated with the components of Metabolic syndrome, such as obesity, diabetes, hypertension and hyperlipidemia. Therefore, strong relation with periodontal disease and metabolic syndrome is suggested. the overall goal of this study is to define the relation between periodontal disease and metabolic syndrome, including atherosclerosis.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Periodontal therapy	Procedure	Normal periodontal therapy is performed.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
features of periodontal disease and metabolic syndrome		one year

Secondary Outcomes

Measure	Description	Time Frame
Pulse wave velocity; max Intima-Media Thickness(IMT); mean IMT; ankle-brachial blood pressure index; toe-brachial blood pressure index		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with periodontal disease

Exclusion Criteria:

Patients with malignant disease
Pregnant women

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tatsuaki Matsubara, MD, PhD	Contact	+81-52-759-2111		matt@dpc.agu.ac.jp

Overall Officials

Name	Affiliation	Role
Tatsuaki Matsubara, MD. PhD	Aichi Gakuin University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aichi Gakuin University	Recruiting	Nagoya	Aichi-ken	464-8651	Japan

Condition Browse Module

MeSH Terms

ID	Term
D010510	Periodontal Diseases
D024821	Metabolic Syndrome

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D007333	Insulin Resistance
D006946	Hyperinsulinism

Browse Leaves

Not provided

Browse Branches

Not provided