Evaluation of the Association Between the Effects of Generalized Stage 3 and 4 Periodontitis on Arterial Stiffness and Cardiovascular Risk: the PAROCAR Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-69
SponsorNantes University Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Periodontal examination and pulse wave velocity

    Other intervention

    Clinical 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

206 Participants
are divided into 2 treatment groups
Group A: Exposed group (periodontitis)Other 1 intervention
Group B: Non-exposed group (healthy control)Other 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 1 At the single study visit

Secondary outcomes

1

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.

Time frame
Day 1 At the single study visit

Other outcomes

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