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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

Tracking Information
First Submitted Date May 20, 2013
First Posted Date May 31, 2013
Last Update Posted Date May 31, 2013
Study Start Date November 2008
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 27, 2013)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Relationship Analysis Between Periodontal Disease and Atherosclerosis in Japanese Medical Cooperation Services
Official Title Analysis of the Relationship Between Periodontal Disease and Atherosclerosis Within a Local Cooperation System of Japanese Medical Services
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 Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Retention:   Samples Without DNA
Description:
blood
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).
Condition
  • Periodontal Disease
  • Atherosclerosis
Intervention Procedure: Periodontal treatment
Study Groups/Cohorts Periodontitis, Lifestyle-related disease
Intervention: Procedure: Periodontal treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 27, 2013)
116
Original Actual Enrollment Same as current
Study Completion Date Not Provided
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01866761
Other Study ID Numbers TCHK_OU-RN605
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Shogo Takashiba, DDS, PhD, Professor of Periodontal Science, Okayama University
Study Sponsor Okayama University
Collaborators Not Provided
Investigators Not Provided
PRS Account Okayama University
Verification Date May 2013