辣木漱口水与洗必泰漱口水相比的防龋效果
辣木漱口水与洗必泰漱口水相比的抗菌、抗牙菌斑和抗龋齿作用:一项随机临床试验
辣木 (MO) 是一种营养丰富的蔬菜树,因其抗菌特性而具有很高的药用价值。 从这种植物中提取各种天然牙科药物的配方及其有效性测试可能会产生有前途的抗菌、抗牙菌斑和抗龋齿剂,而且副作用最小。
研究目的:
第 I 部分:本研究体外部分的目的是从 MO 叶提取物配制无毒漱口水,具有抗菌活性,用于本研究的第 II 部分。 此外,还将评估开发的漱口水的稳定性和功效。
第二部分:这项随机对照试验的目的是评估 MO 漱口水与洗必泰漱口水相比的抗菌、抗牙菌斑和防龋效果。
研究概览
详细说明
问题陈述:口腔疾病仍然是全世界的主要健康问题。 牙周病和龋齿是人类最常见的非传染性口腔疾病,也是导致牙齿脱落的主要原因。 这两种疾病都会导致营养受损并对自尊和生活质量产生负面影响。 随着国际形势向使用无毒环保产品转变,应强调从传统药用植物中开发现代药物以控制人类的各种疾病。 辣木 (MO) 是一种营养丰富的蔬菜树,因其抗菌特性而具有很高的药用价值。 从这种植物中提取各种天然牙科药物的配方及其有效性测试可能会产生有前途的抗菌、抗牙菌斑和抗龋齿剂,而且副作用最小。
研究目的:
第 I 部分:本研究体外部分的目的是从 MO 叶提取物配制无毒漱口水,具有抗菌活性,用于本研究的第 II 部分。 此外,还将评估开发的漱口水的稳定性和功效。
第二部分:这项随机对照试验的目的是评估 MO 漱口水与洗必泰漱口水相比的抗菌、抗牙菌斑和防龋效果。
材料和方法:
第一部分:在这部分的研究中;将使用不同的溶剂提取 MO 叶。 将测定所开发提取物的总酚含量 (TPC) 和总黄酮含量 (TFC) 形式的活性成分。 将评估所有制备的提取物对变形链球菌和牙龈卟啉单胞菌的抗菌活性。 将使用细胞培养设施和 MTT [3-(4, 5-二甲基噻唑-2-基)-2, 5-联苯测试具有最高抗菌活性的 MO 提取物对牙龈成纤维细胞的细胞毒性作用四唑溴化物]测定。 在确定具有最高抗菌活性和无细胞毒性作用的提取物的最低抑菌浓度 (MIC) 后,将制备 MO 漱口水。 开发的漱口水的最终稳定性和功效将在不同的储存条件下进行测试。
第二部分:一项三盲、平行组、随机对照临床试验,涉及 90 名患有生物膜诱发的牙龈炎(菌斑诱发的牙龈炎)和中高龋齿风险的患者。 患者将平均分为三组,接受基础配方漱口水(BF;阴性对照)、掺入基础配方漱口水中的 MO 或商业 0.12% 盐酸洗必泰漱口水(Hexitol®,H;阳性对照)。 经过专业的口腔预防(洗牙和抛光)后,将为项目确定临床参数测量(牙龈指数、菌斑指数、改良沟槽出血指数、染色指数)。 将在基线、第 7、14 和 21 天收集用于变形链球菌菌落形成单位 (CFU) 的未刺激唾液和斑块样本。 将在基线、第 21 天、3 个月和 6 个月时记录唾液流量、唾液 pH 值和国际龋齿检测和评估系统 II (ICDAS II)。
研究类型
注册 (估计的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习联系方式
- 姓名:Mahassen M Farghaly, Professor
- 电话号码:01111230345
- 邮箱:mahassen.farghaly@miuegypt.edu.eg
研究联系人备份
- 姓名:Shahinaz G Elashiry, Assoc Prof
- 电话号码:01015046065
- 邮箱:shahinaz.elashiry@miuegypt.edu.eg
参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准:
- 患者报告的全身游离
- 牙列中至少有 20 颗牙齿(不包括智齿);
- 临床上健康的牙龈(在完整的牙周组织上)
- 根据美国牙周病学会 2017 年牙周疾病和病症分类标准制定的牙科生物膜诱发性牙龈炎(牙菌斑诱发性牙龈炎)
- 中高龋齿风险患者
排除标准:
- 患有牙周炎或需要立即进行其他牙科治疗的患者(当前6个月内)
- 最近 6 个月内服用抗生素的受试者
- 过去 6 个月的牙周治疗
- 孕妇和哺乳期母亲
- 医疗受损的患者
- 任何形式的烟草消费对象
- 佩戴局部义齿或具有临床上不可接受的修复体或牙桥的受试者
- 佩戴正畸矫治器的受试者
- 对化学品或任何草药产品过敏的历史
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:辣木漱口水
根据研究的第一部分,我们将选择最有效(无毒,抗菌作用)的辣木提取物来制备漱口水。
|
将使用具有抗菌和抗牙菌斑作用的无毒辣木提取物
|
|
安慰剂比较:漱口水基础配方
漱口水的基本配方
|
基础配方是阴性对照
|
|
有源比较器:洗必泰
商用 0.12% 氯己定二葡萄糖酸盐漱口水
|
进食后,每天两次(在 21 天的研究期间,每天早上和睡前)使用商用 0.12% 氯己定二葡萄糖酸盐漱口水。
将要求患者使用 15 毫升漱口水漱口 60 秒。
然后咳出。
其他名称:
|
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 |
|---|---|---|
|
牙龈指数 (GI)
大体时间:21天
|
由 Lӧe 和 Silness 评估:分数从 0 到 3,零为正常对象
|
21天
|
|
白点病变
大体时间:21天
|
由 ICDAS II 评估:分数从 0 到 9:零是未修复或未密封的牙齿表面
|
21天
|
合作者和调查者
调查人员
- 学习椅:Mahassen M Farghaly, Professor、Vice president of community services and environmental awareness
出版物和有用的链接
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研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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