Evaluation of the Changes in Matrix Metalloproteinase-9 Levels With Salvadora Persica (Miswak) in Periodontal Fibroblasts and Gingival Crevicular Fluid in Patients With Periodontitis

Официальное название

Evaluation of the Anti-inflammatory Effects of Salvadora Persica on Matrix Metalloproteinase-9 Levels in Periodontal Fibroblasts and Gingival Crevicular Fluid in Patients With Periodontitis: A Randomized Controlled Clinical Trial

Обзор

The study is conducted to evaluate the invitro effect of Salvadora persica (miswak) extract on periodontal fibroblasts production of matrix metalloproteinase-9 (MMP-9) and prostaglandin E2 (PGE2) and correlating the results to clinical outcomes and biomarkers by assessing the MMP-9 and PGE2 levels in gingival crevicular fluid by a randomized controlled clinical trial comparing the use of toothbrush as the control group with miswak chewing stick as a substitute to personal mechanical plaque control in patients with stage II or III grade B periodontitis.

Подробное описание

Despite the clinical benefits mentioned, miswak use have been associated with some drawbacks such as clinical attachment loss; improper use of miswak over a long period can result in a risk of oral tissues injury. To date, there is a lack of comprehensive evidence-based literature to guide a safe and effective accepted practice that can subsequently be used as oral hygiene instructions for miswak users. Correlation between the in vitro and in vivo findings will be performed to evaluate the translational relationship between the effects of miswak on periodontal fibroblast inflammatory activity and the corresponding clinical and biomarker outcomes in patients with periodontitis. Matrix metalloproteinase-9 (MMP-9) and prostaglandin E2 (PGE2) levels obtained from periodontal fibroblast cultures will be compared with gingival crevicular fluid (GCF) MMP-9 and PGE2 levels and clinical periodontal parameters, including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), and plaque index (PI).

Вмешательства

• Поведенческое Salvadora Persica Root
  Miswak chewing sticks will be used as an alternative to the toothbrush
• Поведенческое Toothbrushing
  Modified Bass technique will be employed

Первичные конечные точки

• Matrix metalloproteinase-9 (MMP-9) level in gingival crevicular fluid (GCF) [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Stage II or III, grade B periodontitis

Критерии исключения

• Have poor manual dexterity

• Systemic condition that may affect healing
• Administration of certain medications that may modify the outcomes
• Smoking patients
• Pregnant females
• Periapical involvement in teeth
• Habitual or experienced users of miswak chewing sticks
• History of topical or systemic chemical plaque control during the past 6 months
• History of periodontal surgery during the past 6 months
• Local risk factor that interfere with accessibility for regular personal plaque control aids

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Ahram Canadian University — Giza

Идентификаторы

NCT: NCT07599397 · 123589

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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