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Идёт набор NCT07287540

Anti-inflammatory Nutrition on the Outcomes of Non-surgical Periodontal Therapy

— Наблюдательное Periodontitis

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 trearment, anti-inflammatory nutrition education.
Кому может быть актуально
Состояния в реестре: Periodontitis. Базовые параметры: 20 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
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Официальное название

Evaluation of the Effects of Anti-inflammatory Nutrition on the Outcomes of Non-surgical Periodontal Therapy in Individuals With Periodontitis

Обзор

This study aimed to determine the effect of anti-inflammatory nutrition on non-surgical periodontal treatment in individuals with periodontitis by evaluating gingival crevicular fluid (GCF) and serum biomarkers and clinical periodontal parameters. A total of 100 volunteers identified as having a pro-inflammatory diet (Q3 and Q4) will be included in the study. Individuals will be assigned to two groups. These groups will then be further divided into two groups based on whether or not they will receive anti-inflammatory nutrition education. Group Q3-1 (n=25) will receive non-surgical periodontal treatment and anti-inflammatory nutrition education. Group Q3-2 (n=25) will receive only non-surgical periodontal treatment. Group Q4-1 (n=25) will receive non-surgical periodontal treatment and anti-inflammatory nutrition education. Group Q4-2 (n=25) will receive only non-surgical periodontal treatment. After the periodontal index measurements are completed, the patients will receive non-surgical periodontal treatment. GCF and serum samples, periodontal clinical parameters and Dietary Inflammatory Index will be collected 3 times: at baseline, 1.5 and 3 months after non-surgical periodontal treatment. Levels of interleukin (IL)-1β, IL-10, tumor necrosis factor (TNF)-α, total oxidant status (TOS), total antioxidant status (TAS), and C-reactive protein (CRP) will be assessed from these samples. This will investigate the role of anti-inflammatory nutrition in reducing periodontal inflammation and increasing treatment success.

Вмешательства

  • Другое non surgical periodontal trearment
    All participants will receive nonsurgical periodontal treatment
  • Другое anti-inflammatory nutrition education
    Participants in Groups Q3-1 and Q4-1 will receive anti-inflammatory nutrition education

Первичные конечные точки

  • periodontal pocket depth [Срок оценки: baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.]
  • Clinical attachment loss [Срок оценки: baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.]
Вторичные конечные точки (6)
  • interleukin (IL)-1β level [Срок оценки: baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.]
  • interleukin (IL)-10 level [Срок оценки: baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.]
  • tumor necrosis factor (TNF)-α level [Срок оценки: baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.]
  • serum total oxidant status (TOS) level [Срок оценки: baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.]
  • serum total antioxidant status (TAS) level [Срок оценки: baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.]
  • serum C-reactive protein (CRP) level [Срок оценки: baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.]

Критерии участия

Критерии включения

  • Being systemically healthy
  • Not smoking
  • Not using anti-inflammatory drugs in the last 3 months, antibiotics, or systemic corticosteroids in the last 6 months
  • Not being pregnant or lactating
  • Not having received periodontal treatment in the last 6 months
  • Having at least 20 teeth in the mouth
  • Being diagnosed with periodontitis by the investigator
  • Having a dietary inflammatory index >0

Критерии исключения

  • Having a systemic disease
  • Smoking
  • Using anti-inflammatory drugs within the last 3 months, antibiotics within the last 6 months, or systemic corticosteroids
  • Being pregnant or lactating
  • Having received periodontal treatment within the last 6 months
  • Having fewer than 20 teeth in the mouth
  • No periodontitis

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 1 центр
  • Recep Tayyip Erdoğan University — Rize

Идентификаторы

NCT: NCT07287540 · Recep TayyipErdoğan University

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗