Идёт набор NCT07673185

Omega-3 Plus Low-Dose Aspirin in Smokers With Stage III Periodontitis

Без фазы С лечением Periodontal Disease Periodontitis (Stage 3) Smoking Behaviors

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: Omega-3 Fatty Acids (EPA plus DHA) plus low dose aspirin, Placebo.
Кому может быть актуально: Состояния в реестре: Periodontal Disease, Periodontitis (Stage 3), Smoking Behaviors. Базовые параметры: 30 лет — 50 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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Официальное название

Clinical and Biochemical Evaluation of the Effect of Omega-3 Fatty Acids Plus Low-Dose Aspirin as an Adjunct to Non-Surgical Periodontal Therapy in Smoker Patients With Stage III Periodontitis: A Randomized Double-Blind Placebo-Controlled Clinical Trial

Обзор

This randomized double-blind placebo-controlled clinical trial aims to evaluate the clinical and biochemical effects of omega-3 fatty acids combined with low-dose aspirin as an adjunct to scaling and root planing (SRP) in smoker patients with Stage III periodontitis. The study compares test and control groups regarding periodontal clinical parameters and gingival crevicular fluid interleukin-1 beta (IL-1β) levels Or other inflammatory markers that will be determined later at baseline, 3 months, and 6 months following treatment

Подробное описание

characterized by progressive destruction of the supporting structures of the teeth. Smoking is a major risk factor that increases disease severity and impairs periodontal healing. Host modulation therapy using omega-3 fatty acids and low-dose aspirin has been suggested as a promising adjunctive approach to conventional periodontal treatment due to its anti-inflammatory and pro-resolving effects.

This study is a randomized, double-blind, placebo-controlled clinical trial conducted on smoker patients diagnosed with Stage III periodontitis. Participants are allocated into two groups. The test group receives scaling and root planing (SRP) followed by omega-3 fatty acids and low-dose aspirin, while the control group receives SRP and placebo.

Clinical periodontal parameters including plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing pocket depth (PPD), and clinical attachment level (CAL) are assessed at baseline, 3 months, and 6 months. Gingival crevicular fluid samples are collected for biochemical assessment of interleukin-1 beta (IL-1β) levels using ELISA Or other inflammatory markers that will be determined later.

The primary objective is to evaluate changes in probing pocket depth and clinical attachment level. Secondary outcomes include changes in inflammatory biomarker levels and other periodontal clinical parameters. The findings may provide evidence regarding the efficacy of omega-3 fatty acids and low-dose aspirin as adjunctive host modulation therapy in smoker patients with Stage III periodontitis.

Вмешательства

Препарат Omega-3 Fatty Acids (EPA plus DHA) plus low dose aspirin
participants receive omega3 fatty acid (EPA640+DHA480) plus low dose aspirin (75mg) orally once for 6 months following scaling and root planning
Препарат Placebo
matching placebo capsules administered orally once daily for 6 months following scaling and root planning

Первичные конечные точки

Change in Probing Pocket Depth (PPD) [Срок оценки: Baseline, 3 Months, and 6 Months]
Change in Probing Pocket Depth (PPD) [Срок оценки: Baseline, 3 Months, and 6 Months]
Change in Clinical Attachment Level (CAL) [Срок оценки: Baseline, 3 Months, and 6 Months]

Вторичные конечные точки (1)

Change in Interleukin-1 Beta (IL-1β) Levels [Срок оценки: Baseline, 3 Months, and 6 Months]

Критерии участия

Критерии включения

\- Male or female smokers aged 30 to 50 years.
Diagnosed with Stage III periodontitis according to the 2017 World Workshop classification.
Probing pocket depth (PPD) ≥ 5 mm.
Clinical attachment loss (CAL) ≥ 5 mm.
Presence of at least 20 natural teeth.
Willing and able to provide written informed consent.