独行菜提取物与辛伐他汀作为非手术牙周治疗的辅助局部递送剂
独行菜提取物与辛伐他汀作为非手术牙周治疗的辅助局部递送剂:一项带生化分析的随机对照临床试验
本临床研究的目的是:
- 以评估大麦菜原位凝胶与辛伐他汀凝胶对牙周炎患者临床参数的影响为主要目标。
- 检测局部递送的独行菜和辛伐他汀凝胶对龈沟液中核因子κB(NF-κB)水平的影响作为次要目标。
研究概览
详细说明
牙周炎是一种多因素炎症性疾病,由口腔生物膜在牙齿表面的积累引发,导致牙周支持组织进行性破坏,包括临床附着水平丧失、牙槽骨吸收以及由于根尖迁移导致的牙周袋形成。交界上皮。 它的特征是微生物相关的、宿主介导的炎症,导致牙周组织丧失。 细菌生物膜的形成始于牙龈发炎;然而,牙周炎的发生和发展是基于微生物群失调的生态变化,以响应来自牙龈炎症和组织分解产物的营养物质。 因此,牙周炎被定义为一种影响所有牙齿支撑结构的慢性免疫炎症性疾病。 牙周炎的常规治疗包括洗牙和根面清创术(RSD),这是牙周袋的龈上和龈下机械清创术。 RSD 通过手动仪器或超声波设备完成。 虽然它可能单独有效,但它有局限性,例如在牙周袋较深、难以进入的区域和疾病严重的情况下。 因此,该治疗应辅以辅助抗菌剂以去除残留细菌。 抗菌剂已与机械清创一起用于治疗牙周感染。 在过去的大约 30 年里,已经引入了局部递送的抗感染药物来实现这一目标。 由于该疾病仅限于牙周组织,因此在袋内局部给药是最佳选择。 口袋充当天然水库,便于插入医疗器械。 药物在整个袋中的释放和分布由充当浸出介质的龈沟液 (GCF) 提供。 此外,可以在 GCF 中长时间维持显着的药物水平。 局部给药药物可以克服全身药物的大部分不良副作用。 所有这些因素使口袋内给药成为理想的选择。 他汀类药物如辛伐他汀 (SMV) 已被视为非手术牙周治疗的辅助手段。 他汀类药物最初是作为降胆固醇药物进口的,通过阻碍 3-羟基-3-甲基戊二酰辅酶 A (HMG-CoA) 还原酶发挥作用。 他汀类药物还具有其他特性,包括:抗炎、抗氧化、抗菌和其他多效性作用,例如阻断促炎介质和基质金属蛋白酶 (MMP) 的释放。 因此,他汀类药物已被证明可促进骨形成,并已被证明在牙周治疗中有效。 由于植物的有效性、安全性和治疗优势,现在有许多研究人员将植物作为非手术牙周病治疗的辅助疗法。 Lepidium sativum (LS) 是一种日常使用的草药产品,而无需考虑其益处。 它是属于十字花科的一年生可食用草本植物。 它起源于埃塞俄比亚,在沙特阿拉伯、印度和埃及等许多国家都有发现,后来在欧洲也有发现。 它还有其他名称,例如花园水芹、哈龙、Hab Al-Rashad 和 Thuffa。 它由种子、叶子和根组成。 它的所有部分对于药用效果都很重要。 它有胡椒味,因此可用于自制食物(如沙拉和三明治),尤其是叶子。 种子可用于许多治疗领域,如抗高血糖、抗高血脂、抗腹泻、抗风湿、保肝、抗氧化、抗炎和抗微生物以及胃肠道、皮肤和呼吸系统疾病,以及一些骨折正在愈合。 LS种子含有多种酚类、矿物质、蛋白质、脂肪酸、维生素和碳水化合物。 由于其多酚成分,它对多种细菌具有抗微生物活性,例如 (P. 金黄色葡萄球菌、金黄色葡萄球菌和大肠杆菌)。 该植物的抗氧化作用减少了人体细胞上活性氧的产生,从而减少了疾病的破坏。 由于活性氧 (ROS) 产生的增加,氧应激在许多人类疾病的发生中起着重要作用。 由于 LS 的抗氧化活性和细胞保护作用,用这种植物进行预处理可以抑制 ROS 的产生。 肿瘤坏死因子 α (TNF-α)、白细胞介素 6 和 10 (IL-6、IL-10) 和一氧化氮 (NO) 是在疾病损害中发挥重要作用的促炎介质。 核因子 kappa B (NF-kB) 也通过诱导 TNF-α 在细菌脂多糖 (LPS) 上的转录而在炎症中发挥作用。 LPS 可能会改变抗氧化活性并增强炎症介质的产生。 因此,施用 LS 种子提取物会降低细菌的有效性并改善整体健康状况。
由于缺乏使用 LS 作为牙周炎治疗剂的研究,目前的研究旨在评估该植物在牙周炎治疗中的功效。 此外,由于辛伐他汀和独行菜的多效性,本研究旨在评估 LS 凝胶与辛伐他汀凝胶作为非手术牙周治疗辅助手段的影响。 此外,还评估了 SMV 和 LS 对 GCF 中 NF-κB 水平的影响。
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Cairo、埃及
- Faculty of Dentitry, Ain Shams University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
纳入标准:
- 患者年龄介于25至50岁之间。
- 局部牙周炎,探诊深度≥5mm。 不到 30% 的牙齿受累。
- 两性。
- 患者必须能够返回进行召回访问,并同意在对研究进行全面解释后签署书面同意书。
- 根据美国麻醉医师协会 (ASA I) 的说法,全身免费。
排除标准:
- 吸烟者
- 孕妇和哺乳期妇女或口服避孕药的使用
- 囚犯或受虐者
- 不愿意执行牙菌斑控制的口腔卫生措施的患者。
- 对两种材料的任何成分有过敏史的患者。
- 在研究开始前的最后 6 个月内接受过牙周治疗或使用过任何抗生素/抗炎药。
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:独行菜
15 名参与者 15 名患有局限性 II 期或 III 期和 A 级牙周炎的参与者在研究开始时接受了约 2ml 局部递送的独行菜原位凝胶,并进行了一次洗牙和根面清创
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基线时 2 ml LS 原位凝胶
其他名称:
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有源比较器:辛伐他汀
15 名患有局部 II 期或 III 期和 A 级牙周炎的参与者在研究开始时接受了约 1.2% 的局部递送的辛伐他汀原位凝胶,并进行了一次结垢和根面清创
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基线时 1.2% 的 SMV 原位凝胶
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
临床评估牙周炎患者的菌斑指数(PI)
大体时间:基线变化(最后一次清创后 1 周后)和 3 个月随访期后
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牙齿表面有细菌沉积的百分比。
在每颗牙齿的六个位置(近颊、颊、远颊、近中舌、舌、远舌)记录菌斑指数评分。菌斑指数使用标准直观地记录分数,例如 0、1、2 和 3探测。
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基线变化(最后一次清创后 1 周后)和 3 个月随访期后
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临床评估牙周炎患者的平均沟出血指数 (MSBI)
大体时间:基线变化(最后一次清创后 1 周后)和 3 个月随访期后
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探诊时有出血点的牙齿表面百分比。
在六个部位(近颊、颊、远颊、近中舌、舌侧、远舌)记录出血指数评分。
分数记录为0、1、2、3、4和5。
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基线变化(最后一次清创后 1 周后)和 3 个月随访期后
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临床评估牙周炎患者的探诊深度 (PD)
大体时间:基线变化(最后一次清创后 1 周后)和 3 个月随访期后
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使用密歇根大学 O' 探针在四个点(近中面、中面、远面和中舌)记录牙龈边缘和袋底之间的距离,精确到毫米Williams 的刻度与咬合支架相结合,可实现读数标准化。
探头平行于牙齿的长轴插入。
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基线变化(最后一次清创后 1 周后)和 3 个月随访期后
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临床评估牙周炎患者的临床附着水平 (CAL)
大体时间:基线变化(最后一次清创后 1 周后)和 3 个月随访期后
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使用带有威廉姆斯刻度的密歇根大学 O' 探针以及用于读数标准化的咬合支架,以毫米为单位测量从牙骨质牙釉质交界处 (CEJ) 到袋底部的 CAL。
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基线变化(最后一次清创后 1 周后)和 3 个月随访期后
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
生化检测龈沟液 (GCF) 中的核因子 kappa B (NF-κB) 水平。
大体时间:从基线到 1 个月、从 1 个月到 3 个月以及从基线到 3 个月的变化
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根据制造商的建议,使用市售的酶联免疫吸附测定 (ELISA) 方法测定 GCF 样品中 NF-κB 的水平(ng/ml)。
GCF 样本是使用 perio-paper strips (Oraflow Inc., Smithtown, New York, USA) 收集的。
视觉上被血液污染的 Perio-paper 条被丢弃。
样品立即放入无菌、标记的 Eppendorf 管中,并储存在 -20 ºC 下用于后续检测。
每张 perio-paper 都用 200ul 磷酸盐缓冲盐水 (PBS) 浸泡、涡旋和离心。
上清液用于检测 NF-κB。
该试剂盒由 Bioassay Technology Laboratory (China) Cat No E7121 Hu 提供。
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从基线到 1 个月、从 1 个月到 3 个月以及从基线到 3 个月的变化
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合作者和调查者
调查人员
- 研究主任:Hala Abuelela, Professor、Professor of Oral medicine, Periodontology, and Oral Diagnosis, Faculty of Dentistry, Ain Shams University, Egypt
- 研究主任:Olfat Shaker, Professor、Professor of Medical Biochemistry and Molecular Biology, Faculty of Medicine, Cairo university, Egypt
- 研究主任:Dina Osman, Professor、Professor of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy (Girls), Al Azhar university, Egypt
- 研究主任:Suzan Sarhan, PHD、Lecturer of Oral Medicine, Periodontology, and Oral Diagnosis, Faculty of Dentistry, Ain Shams University, Egypt
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