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Набор скоро начнётся NCT05178563

Mechanisms of Acute Inflammation Following Periodontal Treatment

Без фазы С лечением Inflammation Periodontal Diseases

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: IPT+PDT, IPT+Placebo.
Кому может быть актуально
Состояния в реестре: Inflammation, Periodontal Diseases. 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
Великобритания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Mechanisms of Acute Inflammation Following Periodontal Treatment (STUDENT STUDY)

Обзор

Periodontitis (gum disease) is a chronic inflammatory disease linked to a imbalance of oral microbiome. The most usual treatment involves removal of sub and supra-gingival plaque and calculus otherwise known as Non-surgical periodontal therapy (NSPT). Ample evidence now indicates that Periodontitis and NSPT are linked to both local and systemic inflammation. This in turn also explains the association between periodontitis and a number of systemic diseases including cardiovascular diseases. Vascular endothelium (the innermost lining of blood vessels) exerts protective, anti-inflammatory and anti-clotting functions. As the endothelium ages, and is exposed to the damaging effects of traditional cardiovascular risk factors such as elevated blood pressure, serum cholesterol, glucose and cigarette smoking; these protective properties appear diminished, leading to a state of endothelial dysfunction (ED). Understanding the mechanisms of ED in humans could lead to new therapeutic and/or preventive strategies of CV diseases. Sufficient evidence now suggests that periodontitis and its treatment (removal of sub and supra-gingival plaque and calculus-periodontal therapy) are linked to endothelial dysfunction. Studies have extensively characterized the time-course of a single session of non surgical periodontal treatment (IPT) associated with a one week acute inflammatory response. This substantial inflammatory response is also associated with ED assessed by flow-mediated dilation (FMD) of the brachial artery at 24 hrs. Photodynamic therapy (PDT) helps kill the local pathogens, thus preventing their systemic dissemination; which may ultimately reduce the systemic host inflammatory response generated.

Подробное описание

Periodontitis (gum disease) is a chronic inflammatory disease linked to a imbalance of oral microbiome. The most usual treatment involves removal of sub and supra-gingival plaque and calculus otherwise known as Non-surgical periodontal therapy (NSPT). Ample evidence now indicates that Periodontitis and NSPT are linked to both local and systemic inflammation. This in turn also explains the association between periodontitis and a number of systemic diseases including cardiovascular diseases.

Vascular endothelium (the innermost lining of blood vessels) exerts protective, anti-inflammatory and anti-clotting functions. As the endothelium ages, and is exposed to the damaging effects of traditional cardiovascular risk factors such as elevated blood pressure, serum cholesterol, glucose and cigarette smoking; these protective properties appear diminished, leading to a state of endothelial dysfunction (ED). Understanding the mechanisms of ED in humans could lead to new therapeutic and/or preventive strategies of CV diseases. Sufficient evidence now suggests that periodontitis and its treatment (removal of sub and supra-gingival plaque and calculus-periodontal therapy) are linked to endothelial dysfunction. Studies have extensively characterised the time-course of a single session of intense non surgical periodontal treatment (IPT) associated with a one week acute inflammatory response. This substantial inflammatory response is also associated with ED assessed by flow-mediated dilation (FMD) of the brachial artery at 24 hrs.

The efficacy of periodontal therapy is directly related to the ability of treatment to control the infection sustained by gum bacteria. Several chemical agents, such as antiseptic/bacteriostatic liquids, gels or membranes have been added to the conventional periodontal therapy with the view of improving clinical outcomes. The latest evidence advocates the use of lasers to eliminate bacteria in the periodontal pockets. Photodynamic therapy (PDT) is the process of eradication of target cells by reactive oxygen compound produced after activation of a photo-sensitiser by light of appropriate wavelength. Dental lasers used for PDT can be high-level lasers, low-level laser, and diode lasers. PDT used in dentistry for microbial killing, usually involves the use of low-intensity diode laser irradiation along with photosensitises as a means of arresting the anti-microbial activity.

Researchers and clinicians don't fully understand the mechanism underlying the local and systemic pathways involved in the role of periodontal/oral inflammation on systemic health and diseases Based on the evidence that PDT could kill the local pathogens, thus preventing their systemic dissemination; which may ultimately reduce the systemic host inflammatory response generated. The investigators hypothesized that using PDT before NSPT would result in less local and systemic inflammation/ED Understanding the mechanisms of ED in humans could lead to new beneficial and/or preventive strategies for cardio vascular disease.

Вмешательства

  • Процедура IPT+PDT
    The experimental arm consist of performing IPT in randomly assigning patients to receive local use of photodynamic therapy (PDT).
  • Процедура IPT+Placebo
    IPT+Placebo

Первичные конечные точки

  • The primary objective is to investigate the efficacy and safety of pre-treatment with photodynamic therapy on systemic vascular dysfunction (assessed via FMD) following a single session of non-surgical periodontal therapy (IPT) vs. IPT alone. [Срок оценки: 24 hours post op]
Вторичные конечные точки (11)
  • FMD at different time points following treatment between study groups. [Срок оценки: 0, 1, 3, 7 and 180 days following treatment.]
  • Pulse wave velocity (PWV) at different time points following treatment between study groups. [Срок оценки: 0, 1, 3, 7 and 180 days following treatment.]
  • Evaluate the effect of PDT /IPT on biomarkers of systemic inflammation. [Срок оценки: 0, 1, 3, 7 and 180 days following treatment.]
  • Evaluate the effect of PDT /IPT on biomarkers of systemic inflammation. [Срок оценки: 0, 1, 3, 7 and 180 days following treatment.]
  • Evaluate the effect of PDT /IPT on biomarkers of systemic inflammation. [Срок оценки: 0, 1, 3, 7 and 180 days following treatment.]
  • Evaluate the effect of PDT /IPT on biomarkers of systemic inflammation. [Срок оценки: 0, 1, 3, 7 and 180 days following treatment.]
  • Evaluate the effect of PDT /IPT on markers of endothelial function [Срок оценки: 0, 1, 3, 7 and 180 days following treatment.]
  • Evaluate the effect of PDT /IPT on glycemic profile [Срок оценки: 0, 1, 3, 7 and 180 days following treatment.]
  • Evaluate the effect of PDT /IPT on oxidative profile [Срок оценки: 0, 1, 3, 7 and 180 days following treatment.]
  • Evaluate the effect of PDT/IPT on the monocyte subset, monocyte platelet aggregate (MPA) , and circulating endothelial progenitor cells (EPC). [Срок оценки: 0, 1, 3, 7 and 180 days following treatment.]
  • Investigate the periodontal clinical parameters following IPT with and without the use of PDT. [Срок оценки: 6 months post intervention]

Критерии участия

Критерии включения

  • Male/Female subject must be 18 years of age or over.
  • Affected by periodontitis, with at least 20 sites with PPD>4mm and have at least 20 teeth (excluding wisdom teeth).
  • Have voluntarily signed the informed consent.

Критерии исключения

  • Presence of any systemic diseases (e.g., diabetes mellitus or cardiovascular, kidney, liver or lung disease).
  • Pregnant or breastfeeding.
  • Regular use of analgesic or antibiotics within 1 month before entering the study.
  • Have untreated gross carious lesions and/or insufficient restorations.
  • Allergic to any ingredient in the products provided within the trial as determined by the dental/medical professional monitoring the study.
  • Concurrent participation in other clinical studies.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Великобритания · 1 центр
  • Eastman Dental Hospital — London

Идентификаторы

NCT: NCT05178563 · IRAS Project number 279840

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗