Root canal treatment and cardiovascular risk markers in people with stable coronary artery disease

THE EFFECT OF ENDODONTIC TREATMENT ON CARDIOVASCULAR RISK BIOMARKERS IN PATIENTS WITH STABLE CORONARY ARTERY DISEASE : A RANDOMIZED CONTROLLED TRIAL

This trial tests whether doing a single-visit root canal right away versus delaying it three months changes blood markers of inflammation (hs-CRP and IL-6) in people with stable coronary artery disease who have chronic apical periodontitis.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 30 Years and up
• Sex: All
• Sponsor: Postgraduate Institute of Dental Sciences Rohtak (other)
• Locations: 1 site (Rohtak, Haryana)
• Trial ID: NCT07343804 on ClinicalTrials.gov

What this trial studies

Patients with stable coronary artery disease and a single necrotic tooth with radiographic apical periodontitis were recruited from dental and cardiology outpatient clinics at PGIDS Rohtak. Baseline clinical, radiographic, and laboratory measures including hs-CRP and IL-6 were recorded. Participants were randomized to immediate single-sitting root canal treatment or to delayed endodontic treatment after three months, with clinical and laboratory reassessments at three months in both groups and an additional post-treatment measurement in the delayed group. The study compares changes in systemic inflammatory biomarkers between the two timing strategies to see if endodontic therapy affects cardiovascular risk markers.

Who should consider this trial

Good fit: Adults aged 30 or older with documented stable coronary artery disease and a single permanent tooth with pulp necrosis and radiographic apical periodontitis (PAI ≥3 and radiolucency ≥3 mm) are ideal candidates.

Not a fit: Patients without chronic apical periodontitis, those with acute or unstable coronary syndromes, or those who do not meet the specific radiographic and pulp testing criteria are unlikely to derive benefit from this protocol.

Why it matters

Potential benefit: If successful, timely root canal treatment could lower systemic inflammation markers and potentially reduce cardiovascular risk in affected patients.

How similar studies have performed: Some small studies have reported modest reductions in systemic inflammatory markers after dental infections are treated, but the evidence specific to single-visit endodontic therapy and cardiovascular biomarkers is limited and mixed.

Eligibility criteria

Inclusion Criteria:

1. Individuals 30 years of age and older, with a diagnosis of stable coronary artery disease (CAD) and chronic apical periodontitis.
2. All patients had to present with CAD defined by the Brazilian Society of Cardiology (Xavier et al., 2013) as the documented occurrence of one or more of the following events 6 months before entering the study: history of myocardial infarction, stable angina or ischaemia in non-invasive tests; surgical or percutaneous myocardial revascularization and lesion size of greater than 50% in at least one major coronary artery, as assessed by angiography; presence of angina and positive results of non-invasive testing of ischaemia.
3. Presence of apical periodontitis defined by the presence of at least 1 radiographic radiolucency ( ≥ 3mm) in teeth as assessed both clinically and radiographically ,with periapical index (PAI) scores ≥3 in a single permanent tooth and pulp necrosis verified by cold and electric pulp test.

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Exclusion Criteria:

1. Chronic conditions associated with periodontitis or with changes in systemic inflammation (e.g. diabetes mellitus, rheumatoid arthritis, rheumatic fever, malignancy, respiratory diseases, renal diseases).
2. Presence of localized or diffuse periodontal disease.
3. Acute symptomatic patients
4. Presence of CV risk factor - history of smoking
5. Acute conditions known to affect systemic inflammatory markers (orthopaedic trauma, surgery ,viral infections)
6. Medications (during last 3 months) known to affect systemic inflammatory markers (systemic steroids,immunosuppressants, hormone replacement therapy, contraceptives and systemic antibiotics
7. Obesity (body mass index \[BMI\]≥30 kg/m2
8. Pregnancy \& Lactation.37

Where this trial is running

Rohtak, Haryana

• Post Graduate institute of Dental Sciences, Rohtak — Rohtak, Haryana, India (RECRUITING)

Study contacts

• Study coordinator: Nishant Chauhan, MDS

Conditions: Cardiovascular Disease Risk Factor, Periapical Periodontitis, cardiovascular disease, endodontic therapy, hs-CRP, IL-6