NCT00554034已完成2 期
The Effect of Herbal Extracts on Inflammatory Enzymes in the Gingiva: a Dose Finding Study.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To determine the correct dosing of the herbal Patch [THPP]
研究概览
简要总结
The purpose of this study is to determine the minimal number of patches needed to get an effective response. Patients enrolled in the study will be given 1, 2, 3 or 4 patches in a cycle by the order they enter the study. After the first 20 patients [5 cycles], the effect of the number of patches will be tested. If there is no distinct reduction of beta glucuronidase in the GCF or of gingival index at the tested sites, more patients will be enrolled. Patients will be added one cycle at a time with results being tested and analyzed. The enrollemnts of patients will stop when a dose response will be noticed or 15 cycles have been reached.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Severe localized gingival inflammation [GI index 2 or greater
排除标准
- •Pregnancy or a wish to become pregnant during the study.
- •History of periodontal treatment within the last month.
- •Antibiotic treatment within the last month
- •Use of any antimicrobial mouthrinse within the last month.
- •Participation in another trial one month prior to the study.
- •Inability to behave compliant to the trial protocol by not placing all the patches given, or attending scheduled appointments.
- •Systemic Disease.
- •Patients using salicylate
结局指标
主要结局
To determine the correct dosing of the herbal Patch [THPP]
时间窗: 3 months
次要结局
- To demonstarte the safety of THPP on the gingival tissue and in the oral cavity(3 months)
研究者
研究点 (1)
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