PeriodontisPAROCARNCT07263113
Evaluation of the Association Between the Effects of Generalized Stage 3 and 4 Periodontitis on Arterial Stiffness and Cardiovascular Risk: the PAROCAR Study
A study testing Periodontal examination and pulse wave velocity in people with Periodontis and Atherosclerosis Cardiovascular Disease, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontis, Atherosclerosis Cardiovascular Disease
- What is being tested?
- Periodontal examination and pulse wave velocity
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteFrance
- Study dates
- 10 Apr 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nantes
Nantes, 44093
Camille BECHINA, 0240083333, camille.bechina@chu-nantes.fr
About this study
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.
Read the 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
- Being tested
- Periodontal examination and pulse wave velocity
- Keywords
- periodontis, Atherosclerosis, Cardiovascular Risk, Arterial Stiffness
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal examination and pulse wave velocityOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Exposed group (periodontitis) | Other | Patients diagnosed with generalized stage 3 or 4 periodontitis (Chicago 2017 Classification). Receives: Other: Periodontal examination and pulse wave velocity |
| Non-exposed group (healthy control) | Other | Patients with a healthy periodontium and no history of periodontal disease. Receives: Other: Periodontal examination and pulse wave velocity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 1 At the single study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start10 Apr 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel observational groups
- Masking
- None (open label)
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- French Interregional Group of Clinical Research and Innovation, Université de Nantes, Axelife company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263113
- Sponsor's protocol ID
- RC25_0304
- Other IDs
- 2025-A01525-44
- Acronym
- PAROCAR
- Status last verified
- Jun 2026
- First submitted
- 21 Nov 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Association Between the Effects of Generalized Stage 3 and 4 Periodontitis on Arterial Stiffness and Cardiovascular Risk: the PAROCAR Study
- ClinicalTrials.gov ID
- NCT07263113
- Acronym / sponsor ID
- PAROCAR / RC25_0304
- Keywords
- periodontis, Atherosclerosis, Cardiovascular Risk, Arterial Stiffness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- French Interregional Group of Clinical Research and Innovation, Université de Nantes, Axelife company
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel observational groups
| Arm | Type | Receives |
|---|---|---|
| Exposed group (periodontitis) | Other | Other: Periodontal examination and pulse wave velocityPatients diagnosed with generalized stage 3 or 4 periodontitis (Chicago 2017 Classification). |
| Non-exposed group (healthy control) | Other | Other: Periodontal examination and pulse wave velocityPatients with a healthy periodontium and no history of periodontal disease. |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodontal examination and pulse wave velocityClinical 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). | Other | Exposed group (periodontitis), Non-exposed group (healthy control) |
Primary outcome
Difference in mean pulse wave velocity between exposed and non-exposed groups.
Time frame: Day 1 At the single study visit
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.
1 secondary outcome
Correlation between periodontitis severity (stage 3 or stage 4) and pulse wave velocity.
Time frame: Day 1 At the single study visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
Related trials for Periodontis
RecruitingObservational study
Single-cell and Spatial Transcriptomic Profiling of Gingival Tissues in Aggressive and Chronic Periodontitis: Deciphering Cellular Heterogeneity and Inflammatory Microenvironment Features
Periodontis, Aggressive Periodontitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal examination and pulse wave velocity in people with Periodontis and Atherosclerosis Cardiovascular Disease, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in mean pulse wave velocity between exposed and non-exposed groups. (time frame: Day 1 At the single study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.