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

NCT ID: NCT07263113

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-12-01

Brief Summary

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.

Detailed Description

Periodontal disease is the sixth most prevalent human disease, affecting 45-50% of the adult population, with 11.2% exhibiting severe forms (stages 3 and 4). This chronic inflammation of the gingiva, caused by dysbiosis of the subgingival microbiota, leads to progressive destruction of the supporting tissues of the teeth (alveolar bone and periodontal ligament) and induces local and systemic inflammatory responses.

The translocation of periodontal bacteria and their metabolites into the bloodstream, as well as the systemic release of inflammatory mediators such as C-reactive protein (CRP), interleukins (IL-1β, IL-6), and tumor necrosis factor-alpha (TNF-α), contributes to endothelial dysfunction and oxidative stress. These mechanisms are thought to play a role in the initiation and progression of atherosclerotic lesions, thus linking periodontitis to cardiovascular disease development.

The PAROCAR study aims to provide a proof of concept of the contributory role of severe periodontitis in cardiovascular risk by comparing arterial stiffness between subjects with generalized periodontitis (stage 3-4) and healthy controls.

This is a monocentric, prospective, cross-sectional, observational, exposed/non-exposed study conducted at the Dental Care Center of Nantes University Hospital.

A total of 206 participants will be included:

• 103 exposed subjects with generalized stage 3-4 periodontitis, diagnosed according to the 2017 Chicago Classification
• 103 non-exposed healthy controls, with no clinical or radiographic signs of periodontal disease.

Participants will be strictly matched according to their cardiovascular risk profile, using the SCORE2 algorithm recommended by the European Society of Cardiology (ESC, 2021). SCORE2 estimates the 10-year risk of a first fatal or non-fatal atherosclerotic cardiovascular event based on age, sex, systolic blood pressure, total cholesterol, HDL cholesterol, and smoking status.

Matching by SCORE2 ensures that both groups (periodontitis and control) have equivalent baseline cardiovascular risk levels, thereby minimizing the influence of classical confounders such as age, sex, lipid levels, or hypertension. This approach isolates the potential intrinsic contribution of periodontal inflammation to increased arterial stiffness.

The primary endpoint is the comparison of the mean pulse wave velocity (PWV) between exposed and non-exposed groups.

The secondary endpoints are the correlations between PWV and periodontal severity indices (plaque index, bleeding on probing, probing depth, clinical attachment loss, and staging/grading).

Anthropometric and hemodynamic parameters (BMI, blood pressure, lipid profile) will also be collected to control for potential confounding factors.

By clarifying whether severe periodontitis independently affects arterial stiffness, the PAROCAR study may help refine cardiovascular risk stratification tools and open new perspectives for preventive strategies integrating oral health into global cardiovascular prevention policies

Conditions

Periodontis; Atherosclerosis Cardiovascular Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Exposed group (periodontitis)

Patients diagnosed with generalized stage 3 or 4 periodontitis (Chicago 2017 Classification).

Group Type: OTHER

Periodontal examination and pulse wave velocity

Intervention Type: OTHER

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).

Non-exposed group (healthy control)

Patients with a healthy periodontium and no history of periodontal disease.

Group Type: OTHER

Periodontal examination and pulse wave velocity

Intervention Type: OTHER

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).

Interventions

Periodontal examination and pulse wave velocity

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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,
• Patients with a BMI ≥ 30 kg/m²,
• Patients who have previously undergone periodontal treatment,
• Patients who consume more than 2 units of alcohol per day,
• Patients who refuse to participate in the study,
• Minors and patients under the age of 40,
• Adult patients under legal protection (guardianship, curatorship),
• Patients deprived of their liberty,
• Pregnant or breastfeeding women,
• Patients not affiliated with a health insurance scheme (AME)
• Patients already included in another interventional study

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

French Interregional Group of Clinical Research and Innovation

OTHER

Sponsor Role: collaborator

Université de Nantes

OTHER

Sponsor Role: collaborator

Axelife company

UNKNOWN

Sponsor Role: collaborator

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2025-A01525-44

Identifier Type: OTHER

Identifier Source: secondary_id

RC25_0304

Identifier Type: -

Identifier Source: org_study_id