About this trial
Periodontal diseases are chronic inflammatory conditions affecting nearly half of the adult population and are associated with systemic inflammatory responses. Recent evidence suggests a possible link between severe periodontitis and cardiovascular diseases through shared inflammatory pathways.
The PAROCAR study aims to evaluate the association between generalized periodontitis (stages 3 and 4, 2017 Chicago Classification) and arterial stiffness measured by pulse wave velocity (PWV), compared to matched controls without periodontitis, adjusted for conventional cardiovascular risk factors.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 40-69 years
Minimum of 12 teeth (3 per quadrant)
Written informed consent Exposed group: generalized periodontitis stage 3 or 4 (Chicago 2017 Classification) Non-exposed group: healthy periodontium
Disqualifiers
Patients diagnosed with diabetes,
Patients diagnosed with hypertension or with a history of severe cardiovascular disease,
Patients diagnosed with familial hypercholesterolaemia,
Patients with a medical history or current condition that, in the investigator's opinion, is likely to interfere with the study results,
Trial design
Parallel
Treatments tested in this trial
Periodontal examination and pulse wave velocity
Other interventionClinical oral examination (plaque index, bleeding on probing, probing depth, clinical attachment loss), lipid profile measurement, anthropometric and hemodynamic assessments (BMI, blood pressure, pulse wave velocity).
Treatment groups
Trial outcomes
Primary outcomes
Difference in mean pulse wave velocity between exposed and non-exposed groups.
Comparison of the mean pulse wave velocity (PWV) values between patients with generalized periodontitis and healthy controls, using a Class IIa medical device (pOpmètre®) based on photoplethysmography technology.
Secondary outcomes
Correlation between periodontitis severity (stage 3 or stage 4) and pulse wave velocity.
Assessment of the correlation between arterial stiffness, measured by pulse wave velocity (PWV), and the severity of periodontitis evaluated through periodontal health indicators, including dental plaque accumulation (O'Leary index), bleeding on probing, pocket depth, gingival recession, and clinical attachment loss, as defined by the 2017 Chicago Classification.
Sponsors and contacts
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Nantes University Hospital
Lead sponsor
French Interregional Group of Clinical Research and Innovation
Collaborator
Université de Nantes
Collaborator
Axelife company
Collaborator