Periodontal treatment and reduction of vascular inflammation in patients with peripheral arterial disease

Not Applicable

• Conditions: I70.2; K05.3; Atherosclerosis of arteries of extremities; Chronic periodontitis

• Registration Number: DRKS00004554
• Lead Sponsor: Klin. Abt. für Angiologie, Medizinische Universität Graz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-28
• Study Completion: 2016-02-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

i. Symptomatic PAD
1. PAD Fontaine’s stages II (intermittent claudication) and documented luminal stenosis >70% on ultrasound or angiography
2. PAD Fontaine’s stages III (critical limb ischemia) and documented luminal stenosis >70% on ultrasound or angiography
ii. Severe periodontitis as defined by the presence of at least six natural teeth, including third molars, with at least three teeth with probing depth >4mm; at least two teeth with interproximal clinical attachment loss >2mm; and >10% of sites having bleeding on probing excluding teeth indicated for extraction
iii. Signed informed consent form

Exclusion Criteria

i. PAD Fontaine’s stage IV (tissue damage/loss)
ii. Life expectancy <6 months
iii. Instable cerebrovascular or cardiovascular disease
iv. Clinically apparent infectious disease (e.g. pneumonia, symptomatic urinary tract infection)
v. Systemic inflammatory disease (e.g. chronic inflammatory bowel disease, rheumatoid arthritis, vasculitis by clinical assessment)
vi. Periodontal treatment within 6 months of the study
vii. Mouth infection other than periodontitis
viii. Uncontrolled diabetes
ix. Pregnancy
x. Age <18 years
xi. Consumption of drugs known to affect periodontal status (anticonvulsants, immunosuppressants)
xii. Allergy to penicillin and/or metronidazole

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of vascular inflammation as measured by 18Fluorodeoxyglucose Positron Emission Tomography/CT (FDG-PET/CT) before and 3 months after periodontal treatment

Secondary Outcome Measures

Name	Time	Method
1) reduction of cardiovascular biomarkers before and 3 months after periodontal therapy:<br>- high-sensitivity CRP: Immunturbidimetry<br>- IL-6: ElektroChemiLumineszenzImmunoAssay<br>- VCAM-1: ELISA (enzyme linked immunosorbent assay)<br>- ICAM-1: ELISA<br>- MMP-9: ELISA<br>- MCP-1: ELISA<br>- E-selectin: ELISA<br>- adiponectin: ELISA<br>- Oxidative/nitrosative stress:<br>- ADMA: HPLC (high pressure liquid chromatography)<br>- oxidized-LDL: ELISA<br>- MPO: ChemiLumineszenzImmunoAssay (Abbott Architect)<br><br>2) data on compliance, periodontal outcome-parameter (full mouth plaque score (FMPS) and full mouth bleeding score (FMBS)), cardiovascular outcome-parameter (ancle-brachial index, pulse-wave velocity, flow-mediated dilation) and adverse events will also be measured/evaluated before and 3 months after periodontal therapy.<br><br>3) data on patient's nutritional status (Food Frequency Questionaire, malnutrition screening, 24-h dieatary recall) and body composition (iDEXA Scan)