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Relationship Analysis Between Periodontal Disease and Atherosclerosis in Japanese Medical Cooperation Services

NCT ID: NCT01866761

Last Updated: 2013-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Brief Summary

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Objective: We aimed at analyzing the relationship between periodontal disease and atherosclerosis in medical treatment and periodontal treatment under medical and dental care across borders in a local cooperation system of Japanese medical services.

Materials and methods:

* A prospective multi-center case cohort study was conducted on 37 ambulatory medical patients (with lifestyle-related diseases under consultation in either of the medical clinics registered as collaborative investigation facilities) and 79 periodontal patients (who were seen by the dental clinics registered as collaborative investigation facilities).
* Medical treatment and clinical periodontal treatment were provided on the subjects under medical and dental care across borders by each internal medicine and dental clinics.
* Systemic examination of lifestyle-related disease and periodontal examination were performed before and after periodontal treatment, and the relationships between periodontal and atherosclerosis-related clinical markers were analyzed before and after periodontal treatment.

Detailed Description

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Conditions

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Periodontal Disease Atherosclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Periodontitis, Lifestyle-related disease

Periodontal treatment

Intervention Type PROCEDURE

Interventions

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Periodontal treatment

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Periodontal disease: inflamed gingiva with positive for bleeding on probing or teeth with probing pocket depth more than 4 mm Lifestyle-related disease: Plaques are included when maximum IMT is measured. Furthermore, hypertension was defined as systolic blood pressure of more than 140 mm Hg or diastolic pressure of more than 90 mm Hg, or both, or patients already being treated by anti-hypertensive agents. Hypercholesterolemia was defined by serum concentration of LDL-C of more than 140 mg/dL, or patients already being treated by lipid-lowering agents. Diabetes mellitus was defined by HbA1c of more than 6.9 % (NGSP value) or fasting blood sugar of more than 126 mg/dl or both, or patients already being treated by agents for diabetes.

Exclusion Criteria

* At initial consultation and examination (Baseline), patients with less than 6 months after the onset of acute myocardial infarction (AMI), and with a past history or complication of serious heart disease were excluded. Similarly, those with less than 6 months after cardiovascular revascularization surgery, less than 6 months after the onset of cerebrovascular disorder, or serious liver disease or renal disease were also excluded.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Okayama University

OTHER

Sponsor Role lead

Responsible Party

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Shogo Takashiba, DDS, PhD, Professor of Periodontal Science

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Okayama University of Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Okayama, Okayama-ken, Japan

Site Status

Countries

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Japan

Other Identifiers

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TCHK_OU-RN605

Identifier Type: -

Identifier Source: org_study_id