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

NCT07263113 | Not Yet Recruiting

• 2 other identifiers: RC25_03042025-A01525-44
• Study Type: interventional
• Target: 206
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atherosclerosis Cardiovascular Disease; Periodontis

Keywords

periodontis; Atherosclerosis; Cardiovascular Risk; Arterial Stiffness

Outcome Measures

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.

  Day 1 At the single study visit

Secondary Outcomes (1)

• Correlation between periodontitis severity (stage 3 or stage 4) and pulse wave velocity.

  Day 1 At the single study visit

Study Arms (2)

Exposed group (periodontitis)

OTHER

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

Other: Periodontal examination and pulse wave velocity

Non-exposed group (healthy control)

OTHER

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

Other: Periodontal examination and pulse wave velocity

Interventions

Periodontal examination and pulse wave velocity 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).

Exposed group (periodontitis); Non-exposed group (healthy control)

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead
• Université de Nantes: collaborator
• Axelife company: collaborator
• French Interregional Group of Clinical Research and Innovation: collaborator

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel observational groups

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 4, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-12