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Набор скоро начнётся NCT07127744

Relationship Between Malocclusion Severity and Periodontitis Risk

— Наблюдательное Malocclusion

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Malocclusion. Базовые параметры: 12 лет — 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
Turkey (Türkiye)
Следующий шаг
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Официальное название

Determination of the Relationship Between Orthodontic Malocclusion Severity and Periodontitis Risk Using RANKL, OPG and Oxidative Stress Markers

Обзор

The goal of this observational study is to examine the potential relationship between the severity of orthodontic malocclusion and the risk of developing periodontitis in individuals by evaluating salivary and gingival crevicular levels of RANKL, osteoprotegerin (OPG), and oxidative stress biomarkers. The main question it aims to answer is: Does increasing severity of orthodontic malocclusion contribute to a higher risk of periodontitis through changes in RANKL/OPG balance and oxidative stress levels? Participants with different levels of tooth misalignment (malocclusion) will be examined to assess the condition of their teeth and gums. During this examination, information such as dental plaque, gum bleeding, and the depth of gum pockets will be recorded. In addition, fluid samples collected from the gums will be tested in the laboratory to measure certain biological substances and chemical markers related to the body's balance between harmful and protective effects. These measurements will be done using special laboratory tests.

Подробное описание

The aim of this study is to evaluate the potential relationship between the severity of orthodontic malocclusion and the risk of developing periodontitis through the analysis of RANKL, osteoprotegerin (OPG), and oxidative stress biomarkers. The mechanical effects of malocclusion on teeth and surrounding tissues may lead to inflammation and tissue destruction within the periodontal structures. Understanding the biomolecular mechanisms involved in this process is essential for early diagnosis and preventive approaches.

This cross-sectional study will include individuals with varying degrees of malocclusion severity. Orthodontic status will be determined through clinical evaluation and standardized indices, while periodontal status will be assessed using parameters such as the plaque index, papillary bleeding index, and probing pocket depth. In addition, gingival crevicular fluid (GCF) samples will be collected from participants to measure levels of RANKL, OPG, total antioxidant capacity (TAC), and total oxidative status (TOS) using the ELISA method.

The data obtained will help reveal whether orthodontic abnormalities increase the risk of periodontal disease and how this risk correlates with biomarker levels. The study emphasizes the importance of a holistic evaluation of both orthodontic and periodontal health.

Первичные конечные точки

  • Gingival crevicular fluid collection [Срок оценки: Day 1]
  • Clinical Periodontal Parameters (Plaque Index) [Срок оценки: Day 1]
  • Periodontal Clinical Parametres (Papillary Bleeding Index) [Срок оценки: Day 1]
  • Periodontal Clinical Parametres (Bleeding on Probing Index) [Срок оценки: Day 1]
  • Periodontal Clinical Parametres (Probing Pocket Depth) [Срок оценки: Day 1]
  • Periodontal Clinical Parametres (Clinical Attachment Loss) [Срок оценки: Day 1]
Вторичные конечные точки (1)
  • Determination of RANKL, OPG, TAS and TAC by ELISA [Срок оценки: 4th month]

Критерии участия

Критерии включения

  • Patients between the ages of 12 and 18,
  • Patients with all permanent teeth,
  • Not having taken antibiotics, steroids, and/or nonsteroidal anti-inflammatory drugs in the last 3 weeks,
  • Not having an active infectious disease,
  • Not having chronic medication use that affects periodontal tissues (cyclosporine A, Phenytoin),
  • Not having taken antioxidant supplements in the last 6 months.

Критерии исключения

  • Presence of any congenital craniofacial deformity (cleft lip and palate or any other craniofacial syndrome or deformity),
  • Patients who have previously started or completed orthodontic treatment,
  • Patients who have received periodontal treatment in the last 6 months,
  • Acute illness,
  • Systemic illness, mental illness, immunosuppressive medications, or immunodeficiency.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Turkey (Türkiye) · 1 центр
  • Department of Periodontology of the Faculty of Dentistry of Recep Tayyip Erdogan Universit — Rize

Идентификаторы

NCT: NCT07127744 · periortho05/2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗