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

Atherosclerosis Clinical Trial

— RAPA-JMCS  

Official title:

Analysis of the Relationship Between Periodontal Disease and Atherosclerosis Within a Local Cooperation System of Japanese Medical Services

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01866761
• Other study ID #: TCHK_OU-RN605
• Status: Completed
• Phase: N/A
• First received: May 20, 2013
• Last updated: May 27, 2013
• Start date: November 2008

Study information

• Verified date: May 2013
• Source: Okayama University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review BoardJapan: Ministry of Education, Culture, Sports, Science and Technology
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• Gingival Diseases
• Periodontal Disease
• Periodontal Diseases

Intervention

Procedure:
• Periodontal treatment

Locations

Country	Name	City	State
Japan	Okayama University of Graduate School of Medicine, Dentistry and Pharmaceutical Sciences	Okayama

Sponsors (1)

Lead Sponsor	Collaborator
Okayama University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At following 3-time points; Baseline, After initial preparation of periodontal treatment, Starting point of supportive periodontal therapy	an expected average of 1.5 year	No