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OpenTrials
Completed

NCT Number: NCT01866761

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Okayama, Okayama-ken, 700-8525, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Periodontal Treatment

Procedure

Primary outcomes

  1. 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Okayama University

Other

Registry information

Official study title

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

Acronym: RAPA-JMCS

Important dates

Study start
2008
Primary completion
2012
First posted
May 31, 2013
Registry last updated
May 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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