Effects of Non-surgical Periodontal Therapy on Cardiovascular Risk
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Non-surgical periodontal therapy, Control periodontal treatment.
- Кому может быть актуально
- Состояния в реестре: Cardiovascular Diseases, Periodontitis. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Effects of Non-surgical Periodontal Therapy on Cardiovascular Risk in People at Risk of Cardiovascular Disease
Обзор
This study is to evaluate whether non-surgical periodontal therapy can help to control the cardiovascular risk among patients with moderate/severe periodontitis and at risk of cardiovascular disease.
Подробное описание
Previous studies showed that the treatment of periodontitis can partially improve the control of risk factors of cardiovascular disease (e.g. blood pressure, interleukin 6), whereas the evidence is still limited. Moreover, there is currently no study reporting the impact of periodontal treatment on the overall risk of cardiovascular disease. The prevalence of periodontitis in China was 62.4%. In clinical practice, a large number of patients with moderate/severe periodontitis and at risk of cardiovascular disease seek medical advice. However, the existing guidelines lack relevant recommendations. Therefore, this study intends to evaluate whether non-surgical periodontal therapy can help to control cardiovascular risk.
376 patients with moderate/severe periodontitis and at risk of cardiovascular disease will be randomized. Those randomized to the intervention arm will receive non-surgical periodontal therapy which includes full-mouth subgingival scaling and root planing. Those randomized to the control arm will receive supragingival ultrasonic scaling. All patients were given instructions on basic oral hygiene.
Вмешательства
- Процедура Non-surgical periodontal therapy
Non-surgical periodontal therapy includes basic oral hygiene instructions and full-mouth subgingival scaling and root planing under local anesthesia. - Процедура Control periodontal treatment
Control periodontal treatment includes basic oral hygiene instructions and full-mouth supragingival ultrasonic scaling.
Первичные конечные точки
- Change from Baseline Cardiovascular risk (Framingham risk score (FRS)) at 1 year. [Срок оценки: Baseline; 1 year]
Вторичные конечные точки (12)
- Change from baseline systolic blood pressure at 1 year after enrollment. [Срок оценки: Baseline; 1 year]
- Change from baseline diastolic blood pressure at 1 year after enrollment. [Срок оценки: Baseline; 1 year]
- Change from baseline fasting blood glucose at 1 year after enrollment. [Срок оценки: Baseline; 1 year]
- Change from baseline glycosylated hemoglobin at 1 year after enrollment. [Срок оценки: Baseline; 1 year]
- Change from baseline total cholesterol at 1 year after enrollment. [Срок оценки: Baseline; 1 year]
- Change from baseline triglyceride at 1 year after enrollment. [Срок оценки: Baseline; 1 year]
- Change from baseline low-density lipoprotein cholesterol at 1 year after enrollment. [Срок оценки: Baseline; 1 year]
- Change from baseline high-density lipoprotein cholesterol at 1 year after enrollment. [Срок оценки: Baseline; 1 year]
- Change from baseline high sensitivity C-reactive protein at 1 year after enrollment. [Срок оценки: Baseline; 1 year]
- Change from baseline interleukin-6 at 1 year after enrollment. [Срок оценки: Baseline; 1 year]
- Change from baseline cardiovascular risk (CHINA-PAR) at 1 year after enrollment. [Срок оценки: Baseline; 1 year]
- Change from baseline community periodontal index at 1 year after enrollment. [Срок оценки: Baseline; 1 year]
Критерии участия
Критерии включения
- Age ≥ 18 years;
- At risk of cardiovascular disease (defined as "Framingham Score" predicted 10-year risk of cardiovascular disease ≥ 20%);
- Moderate//severe periodontitis;
Критерии исключения
- Cardiovascular diseases at baseline (coronary heart disease, stroke and peripheral artery disease);
- Received periodontal treatment within the past 6 months;
- Pregnant or lactating females;
- Non residents of Guangzhou and its surrounding cities or expected to leave Guangzhou or its surrounding cities within 1 year;
- Malignant tumors or other end-stage diseases with life expectancy less than 1 year;
- End-stage renal disease;
- Patients with high bleeding risk, high blood pressures or other situations that make them unable to receive interventions;
- Refuse to provide informed consent;
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
- Двойное слепое
- Основная цель
- Профилактика
Центры проведения
Китай · 2 центра
- Stomatological Hospital, Southern Medical University — Гуанчжоу
- Nanfang Hospital, Southern Medical University — Гуанчжоу
Идентификаторы
NCT: NCT05459727 · NFEC-2022-243