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Clinical Trials in India / NCT07343804
Recruiting Not applicable

THE EFFECT OF ENDODONTIC TREATMENT ON CARDIOVASCULAR RISK BIOMARKERS IN PATIENTS WITH STABLE CORONARY ARTERY DISEASE

NCT07343804 · tracked via the Priya Life Science India tracker
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
Phase
Not applicable
Started
2025-11-01
Last updated
2026-01-15

Condition(s) studied

Cardiovascular Disease Risk FactorPeriapical Periodontitis

Investigational drug(s) / intervention(s)

root canal treatment and intracanal medicament

root canal treatment and intracanal medicament: Access opening will be done after rubber dam isolation and administration of local anesthesia. debridement of the pulp chamber will be done and all canal orifices will be identified. Negotiation of canals will be done. Working length will be determined using root ZX apex locator and will be verified radiographically. Coronal enlargement will be done using Gates-Glidden drills. The apical third of the root canal will be instrumented up to size 35 for mesial and up to size 45 for distal canals. Finally, root canals will be further instrumented with step-back technique enlargement in 1 mm increments to 3 sizes larger than the master apical file. Irrigation will be carried out using 5 mL of a 5% NaOCl solution between files. The root canals will be dried using paper points and filled with lateral condensed gutta-percha (Dentsply Maillefer) and Zinc oxide Eugenol based sealer mixed according to manufacturers' instructions.

Study summary

Study subjects were obtained from the pool of OPD patients in the Department of Conservative Dentistry and Endodontics, PGIDS, Rohtak, and the Department of Cardiology, PGIMS, Rohtak. Baseline clinical, radiographic, and laboratory parameters (hsCRP and IL-6) were recorded. Patients were then randomly allocated to one of the two groups. In the test group, single-sitting root canal treatment was performed immediately, while in the control group, delayed endodontic intervention (after 3 months) was performed after three months. Clinical and laboratory parameters were again assessed at the end of 3 months in both groups. hsCRP and IL-6 indices were again done in the delayed treatment group after 3 months of root canal treatment.

Eligibility

Sex
ALL
Min age
30 Years
Max age
Healthy volunteers
No
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. \- 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Post Graduate institute of Dental Sciences, Rohtak Rohtak Haryana Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07343804 on ClinicalTrials.gov ↗ ← All trials in India