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临床试验/NCT00250289
NCT00250289已完成1 期

Invivo Study of the Efficacy of an Innovative Herbal Formula and Delivery System on Oral Malodor

Hadassah Medical Organization2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2006年3月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
15
试验地点
2
主要终点
Oral malodor will be measured with a Halimeter monitor and an odor judge before the sticker application and following the application every 7 minutes until the odor level would reach plateau.

研究概览

简要总结

the use of a herbal formulation containing sage, echinacea,lavender and mastic gum would prevent oral malodor if delivered in an appropriate delivery system to enable slow release of the active ingredients.

详细描述

Oral malodor (Halitosis, Fetor ex ora) is a common and disturbing condition, affecting according to some studies about one quarter of the population. This condition may start at any time from early childhood through adolescence, adulthood and old age and vary in character and severity.The bacteria responsible for malodor production are for the most part Gram negative oral bacteria (2- 4) such as Porphyromonas gingivalis, Fusobacterium nucleatum and Prevotella intermedia. These bacteria reside on various locations within the oral cavity (e.g. tongue dorsum, interdental space, periodontal pockets, tonsils) and breakdown salivary and oral proteins into their amino acid building blocks. Some of these amino acids (e.g. methionine, cysteine, tryptophan, lysine) are further metabolized yielding malodorous volatile products such as methylmercaptan, hydrogen sulfide, indole, skatole and cadaverine (5-7). These are foul smelling compounds, which are released during exhalation and speech.in our study we intend to use an aprooved mucosal sticker containing carbopol and hydroxypropylcellulose mixed with the herbal ingredients and placed on the palatal mucosa.than mesure the volatile sulfur compounds to observe if the composition has antimalodor effect and for how long. the herbal ingredients are used for many years for medicinal and nutritional purposes. if our hypothesis is right we might have another formulation and method of application to prevent oral malodor

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • random gender, age and healthy people

排除标准

  • used antibiotics in the last three months or suffer from systemic disease

结局指标

主要结局

Oral malodor will be measured with a Halimeter monitor and an odor judge before the sticker application and following the application every 7 minutes until the odor level would reach plateau.

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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