I70.2 K05.3
Conditions
Interventions
Group 1: Periodontal therapy with antibiotic therapy at the study center (University Dental School). Periodontal therapy usually comprises three sessions within one week.
Group 2: Periodontal therapy
Sponsors
Klin. Abt. für Angiologie, Medizinische Universität Graz
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of vascular inflammation as measured by 18Fluorodeoxyglucose Positron Emission Tomography/CT (FDG-PET/CT) before and 3 months after periodontal treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) reduction of cardiovascular biomarkers before and 3 months after periodontal therapy: - high-sensitivity CRP: Immunturbidimetry - IL-6: ElektroChemiLumineszenzImmunoAssay - VCAM-1: ELISA (enzyme linked immunosorbent assay) - ICAM-1: ELISA - MMP-9: ELISA - MCP-1: ELISA - E-selectin: ELISA - adiponectin: ELISA - Oxidative/nitrosative stress: - ADMA: HPLC (high pressure liquid chromatography) - oxidized-LDL: ELISA - MPO: ChemiLumineszenzImmunoAssay (Abbott Architect) 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. 3) data on patient's nutritional status (Food Frequency Questionaire, malnutrition screening, 24-h dieatary recall) and body composition (iDEXA Scan) | — |
Countries
Austria
Contacts
Public ContactGerald Seinost
Klin. Abt. für Angiologie, Medizinische Universität Graz
Outcome results
None listed