Идёт набор NCT06789458

Assessment of Pro-Resolution Mediator Levels in Periodontitis Stage III and IV Before and After Periodontal Therapy

Без фазы С лечением Peridontal Disease

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: Professional mechanical plaque control.
Кому может быть актуально: Состояния в реестре: Peridontal Disease. Базовые параметры: 18 лет — 80 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: Египет
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This study aims to assess Pro-Resolution Mediator levels during non-surgical periodontal therapy in individuals with Stage III and IV periodontitis, comparing them to healthy subjects. Periodontitis, a chronic inflammatory condition affecting tooth-supporting tissues, can lead to tooth loss and systemic complications. Understanding the role of pro-resolving lipid mediators in inflammation resolution may offer insights into therapeutic benefits associated with these mediators.

Подробное описание

Periodontitis is a chronic inflammatory disease that affects the tooth-supporting tissues, it produces a slow destruction of the periodontium that may eventually result in tooth loss. Periodontitis is caused by a dysbiosis of the immune system where there is an imbalance between the processes that activate and terminate the inflammatory process.(Van Dyke, 2020) Pro-resolving lipid mediators (PMs) play a key role in actively resolving inflammation, modulating immune responses, and promoting tissue healing. However, the understanding of PMs in periodontitis and their role in the enduring nature of the disease has not been sufficiently studied in a clinical setting. It has been suggested that PM levels vary between periodontitis patients and healthy individual with periodontal therapy potentially restoring the balance between pro- and anti-inflammatory mediators. (Van Dyke, 2017) The study aims to provide insights into inflammation resolution mechanisms in periodontitis and the therapeutic potential of PMs.

This study aims to Assess Pro-Resolution Mediator Levels During Periodontal Therapy in Patients with Periodontitis Stage III and IV compared to healthy patients.

Hypothesis Null Hypothesis: pro-resolution mediators' level before and after non-surgical treatment in stage III and IV periodontitis compared to healthy patients, there will be no difference in level before and after non-surgical treatment between stage III and IV periodontitis compared to healthy patients.

Trial design:

The current study design is a before and after trial with a single (interventional) population measured before and after treatment compared to a negative control of healthy patients.

Вмешательства

Процедура Professional mechanical plaque control
thisThe first step in therapy is aimed at guiding behavior change by motivating the patient to undertake successful removal of supragingival dental biofilm and risk factor control and may include the following interventions: * Interventions to improve the effectiveness of oral hygiene \[motivation, instructions (oral hygiene instructions, OHI) * Professional mechanical plaque removal (PMPR), which includes the professional interventions aimed at removing supragingival plaque and calculus, as we

Первичные конечные точки

Change in level of GCF lipoxin A4 [Срок оценки: preoperative, one day, one month and 3 months postoperative]

Вторичные конечные точки (6)

Change in level of GCF Protectin [Срок оценки: preoperative, one day, one month and 3 months postoperative]
Probing pocket depth (PPD) [Срок оценки: preoperative, and 3 months postoperative]
Bleeding On Probing (BOP) [Срок оценки: preoperative, and 3 months postoperative]
Plaque index (PI) [Срок оценки: preoperative, and 3 months postoperative]
Clinical Attachment Level (CAL) [Срок оценки: preoperative, and 3 months postoperative]
Number of pockets closed [Срок оценки: preoperative, and 3 months postoperative]

Критерии участия

Критерии включения

Adult patients above 18 years old.
Interdental CAL at site of greatest loss ≥5 mm or extending to middle third of the root.
Interdental CAL at site of greatest loss ≥8 mm or extending to apical third of the root.
Probing depth ≥6 mm.
Vertical bone loss ≥3 mm.
Tooth loss due to periodontitis of ≤4 teeth. (Periodontitis Stage III)
Tooth loss due to periodontitis of ≥5 teeth. (Periodontitis Stage IV)
Furcation involvement Class II or III Moderate ridge defect.

Критерии исключения

1\. Pregnancy or lactation. 2. Smoking more than 20 cigarettes. 3. Immuno-inflammatory conditions of the skin and oral mucosa 4. systemic conditions affecting bone turnover and periodontal health status (e.g. endocrine and connective tissue diseases, bisphosphonate antiresorptive therapy, gastrointestinal diseases related to nutrition and mineral metabolism) 5. Periodontal or orthodontic treatment at least 6 months before the start of the study 6. Use of anti-inflammatory and antimicrobial agents within 3 months before sampling

Inclusion criteria for healthy group: