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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00553007
Other study ID # AGU070001
Secondary ID
Status Recruiting
Phase N/A
First received November 1, 2007
Last updated November 1, 2007
Start date October 2007
Est. completion date October 2009

Study information

Verified date October 2007
Source Aichi Gakuin University
Contact Tatsuaki Matsubara, MD, PhD
Phone +81-52-759-2111
Email matt@dpc.agu.ac.jp
Is FDA regulated No
Health authority Japan: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date October 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Patients with periodontal disease

Exclusion Criteria:

- Patients with malignant disease

- Pregnant women

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
Periodontal therapy
Normal periodontal therapy is performed.

Locations

Country Name City State
Japan Aichi Gakuin University Nagoya Aichi

Sponsors (1)

Lead Sponsor Collaborator
Aichi Gakuin University

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary features of periodontal disease and metabolic syndrome one year
Secondary Pulse wave velocity; max Intima-Media Thickness(IMT); mean IMT; ankle-brachial blood pressure index; toe-brachial blood pressure index one year
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