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Relationship Analysis Between Periodontal Disease and Atherosclerosis in Japanese Medical Cooperation Services (RAPA-JMCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01866761
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : May 31, 2013
Sponsor:
Information provided by (Responsible Party):
Shogo Takashiba, DDS, PhD, Professor of Periodontal Science, 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.

Condition or disease Intervention/treatment
Periodontal Disease Atherosclerosis Procedure: Periodontal treatment

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Study Type : Observational [Patient Registry]
Actual Enrollment : 116 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Analysis of the Relationship Between Periodontal Disease and Atherosclerosis Within a Local Cooperation System of Japanese Medical Services
Study Start Date : November 2008
Actual Primary Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Group/Cohort Intervention/treatment
Periodontitis, Lifestyle-related disease Procedure: Periodontal treatment



Primary Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
blood


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This clinical study was performed by the local clinics which belonged to Tokyo Medical Practitioners Association, Tokyo Dental Practitioners Association, and Chiba Medical Practitioners Association. 37 patients (with lifestyle-related diseases under consultation in either of 16 medical clinics), and 79 periodontal patients (not undergoing treatment at a medical clinic,) were enrolled. The subjects constituted a broad cross-section of the local society. Medical treatment at an internal medicine clinic and clinical periodontal treatment including periodontal surgery at a dental clinic were performed on all the subjects. Twenty-six patients dropped out of the study and medical treatment and periodontal treatment were provided to the remaining 90 subjects (mean ages: 59.2 ± 12.3 yrs).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866761


Locations
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Japan
Okayama University of Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Okayama, Japan, 700-8525
Sponsors and Collaborators
Okayama University
Additional Information:

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Responsible Party: Shogo Takashiba, DDS, PhD, Professor of Periodontal Science, Professor, Okayama University
ClinicalTrials.gov Identifier: NCT01866761    
Other Study ID Numbers: TCHK_OU-RN605
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: May 31, 2013
Last Verified: May 2013
Additional relevant MeSH terms:
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Periodontal Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Mouth Diseases
Stomatognathic Diseases