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
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Matrix metalloproteinase-9 (MMP-9) level in gingival crevicular fluid (GCF)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage II or III, grade B periodontitis
排除标准
- •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
研究组 & 干预措施
Miswak group.
The test group that will be assigned to use miswak chewing sticks for personal plaque
干预措施: Salvadora Persica Root (Behavioral)
Toothbrush group
The control group that will be assigned to use the toothbrush for personal plaque
干预措施: Toothbrushing (Behavioral)
结局指标
主要结局
Matrix metalloproteinase-9 (MMP-9) level in gingival crevicular fluid (GCF)
时间窗: 3 months
GCF will be collected at baseline and after 3 months to assess the MMP-9 level change by ELISA kit
次要结局
未报告次要终点
研究者
Marwa El Sayed Abbas Ahmed
Lecturer of Oral Medicine and Periodontology, Ahram Canadian University
Cairo University