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Идёт набор NCT07312552

Association of Periodontal Status and Smoking With Salivary Inflammasome Markers

— Наблюдательное Periodontitis Periodontal Disease Periodontal Health Smoking

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: Periodontal examinations, Collection of saliva samples.
Кому может быть актуально
Состояния в реестре: Periodontitis, Periodontal Disease, Periodontal Health, Smoking. Базовые параметры: 18 лет — 65 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
Turkey (Türkiye)
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

The Impact of Periodontal Status and Smoking on Salivary Inflammasome Levels: A Cross-Sectional Study

Обзор

The aim of this study is to evaluate the relationship between periodontal status and salivary levels of the inflammasomes NOD-like receptor family, pyrin domain containing 3 (NLRP-3), NOD-like receptor family, pyrin domain containing 6 (NLRP-6), NOD-like receptor family, pyrin domain containing 12 (NLRP-12), NOD-like receptor family, CARD domain containing 5 (NLRC-5), interleukin-1 beta (IL-1β) and interleukin-10 (IL-10). Furthermore, this study aims to investigate whether the salivary levels of these inflammasomes may serve as potential diagnostic biomarkers for distinguishing individuals with periodontitis from those without. In addition, the potential role of smoking in modulating the relationship between periodontal status and salivary inflammasome levels will also be explored.

Подробное описание

The aim of this study was to determine the periodontal status and smoking status of the participants, to obtain clinical periodontal records and to explain their relationship with salivary NLRP-3 NLRP-6, NLRP-12, NLRC-5, IL-1β and IL-10 levels.

The participants included in the study will be divided into four groups: smokers with periodontal disease, non-smokers with periodontal disease, smokers without periodontal disease, and non-smokers without periodontal disease. Systemic and dental anamnesis of the participants will be taken, smoking habits will be evaluated, medical records and current diagnoses will be examined, intraoral examinations will be performed and periodontal records will be taken. The periodontal status of the participants will be diagnosed according to the 'Classification of Periodontal and Peri-implant Diseases and Conditions' accepted at the 2017 World Workshop, supported by the American Academy of Periodontology (AAP) and the European Federation of Periodontology (EFP).

Saliva samples will be collected before clinical periodontal measurements. The collected saliva samples will be stored at -80°C until analyzed. Salivary NLRP-3, NLRP-6, NLRP-12, NLRC-5, IL1β, and IL-10 levels will be measured using an enzyme-linked immunosorbent assay (ELISA) method.

Вмешательства

  • Диагностический тест Periodontal examinations
    With periodontal evaluation, plaque percentage, probing pocket depth, percentage of bleeding on probing, clinical attachment level, number of teeth, periodontal inflammatory surface area (PISA) parameters are recorded.
  • Диагностический тест Collection of saliva samples
    Levels of salivary NOD-like receptor family, pyrin domain containing 3 (NLRP-3), NOD-like receptor family, pyrin domain containing 6 (NLRP-6), NOD-like receptor family, pyrin domain containing 12 (NLRP-12), NOD-like receptor family, CARD domain containing 5 (NLRC-5), interleukin-1 beta (IL-1β), and interleukin-10 (IL-10) will be determined using an enzyme-linked immunosorbent assay (ELISA).

Первичные конечные точки

  • Clinical attachment level (mm) [Срок оценки: Baseline]
  • Probing pocket depth [Срок оценки: Baseline]
  • Bleeding on probing [Срок оценки: Baseline]
Вторичные конечные точки (8)
  • Plaque percentage [Срок оценки: Baseline]
  • Periodontal inflammatory surface area (PISA) [Срок оценки: Baseline]
  • Salivary interleukin-10 (IL-10) levels [Срок оценки: Baseline]
  • Salivary interleukin-1beta (IL-1β) levels [Срок оценки: Baseline]
  • Salivary NOD-like receptor family, pyrin domain containing 3 (NLRP-3) levels [Срок оценки: Baseline]
  • Salivary NOD-like receptor family, pyrin domain containing 6 (NLRP-6) levels [Срок оценки: Baseline]
  • Salivary NOD-like receptor family, pyrin domain containing 12 (NLRP-12) levels [Срок оценки: Baseline]
  • Salivary NOD-like receptor family, CARD domain containing 5 (NLRC-5) levels [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • systemically healthy,
  • clinical diagnosis of periodontitis,
  • clinical diagnosis of periodontal health

Критерии исключения

  • history of regular use of systemic antibiotics, anti-inflammatory, or antioxidant drugs (previous 6 months);
  • nonsurgical periodontal treatment (previous 6 months);
  • surgical periodontal treatment (previous 12 months);
  • presence of <20 teeth;
  • current medications affecting gingival health (calcium channel blockers, phenytoin, cyclosporine, and hormone replacement therapy);
  • diabetes diagnosis; rheumatoid arthritis diagnosis; and pregnancy, lactating, or excessive alcohol consumption.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Turkey (Türkiye) · 1 центр
  • Uskudar University, Faculty of Dentistry — Istanbul

Идентификаторы

NCT: NCT07312552 · KKARADURAN1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗