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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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. Fi

Первичные конечные точки

• To evaluate the levels of hs-CRP and IL-6 in CAD patients with apical periodontitis. [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Individuals 30 years of age and older, with a diagnosis of stable coronary artery disease (CAD) and chronic apical periodontitis.
• 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.
• 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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Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Индия · 1 центр

• Post Graduate institute of Dental Sciences, Rohtak — Rohtak

Идентификаторы

NCT: NCT07343804 · Nishant Chauhan

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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