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

Completed

• Conditions: Atherosclerosis; Periodontal Disease
• Interventions: Procedure: Periodontal treatment

• Registration Number: NCT01866761
• Lead Sponsor: Okayama University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2012-01
• Status Verified: 2013-05
• Study First Submitted: 2013-05-20
• Study First Submitted QC: 2013-05-27
• Last Update Submitted: 2013-05-27
• Study First Posted: 2013-05-31
• Last Update Posted: 2013-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Periodontitis, Lifestyle-related disease	Periodontal treatment	-

Primary Outcome Measures

Name	Time	Method
Relation between probing pocket depth and anti-periodontopathic bacteria IgG antibody titer for periodontitis and the MAX intima-media thickness, urea sugar, urea protein, urea occult blood, creatinine, and eGFR for atherosclerosis	an expected average of 1.5 year	At following 3-time points; Baseline, After initial preparation of periodontal treatment, Starting point of supportive periodontal therapy

Trial Locations

Locations (1)

Okayama University of Graduate School of Medicine, Dentistry and Pharmaceutical Sciences; 🇯🇵 Okayama, Japan