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临床试验/NCT01046812
NCT01046812已完成不适用

Halitosis Devised Questionnaire Evaluating a New Treatment

New York Head & Neck Institute1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年9月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Evaluation of Caphosol in treating Halitosis

研究概览

简要总结

The investigators propose a novel assessment of oral malodor (halitosis) by a quality of life (QOL) questionnaire designed specifically for halitosis and a new treatment for halitosis by improvement of mouth dryness.

详细描述

Halitosis is a common symptom which can affect people of all ages. It may decrease self confidence and social interactions. Oral halitosos is the consequence of microbial (mainly Gram negative bacteria) breakdown of food debris, cells, saliva, and blood. The agents that give rise to halitosis include especially the volatile sulphur compounds (VSC), diamines, and short chain fatty acids of which only the VSC can be detected in the clinical setting, making the detection of halitosis often very hard. The most common cause for oral halitosis is poor oral hygiene due to gingivitis or periodontitis. Other causes include bacterial accumulation on the posterior tongue, tonsillitis and others. Dry mouth has been implicated as a potential cause in halitosis.

Due to the lack of quantitative objective measuring to the severity of halitosis and especially in the face of the subjective nature of halitosis as occurs commonly a subjectively measurement is necessary. As no current QOL exists for measurement of halitosis formulation of such a questionnaire can enable a measurement of subjective halitosis with change observed over time or with intervention.

We intend to treat halitosis with a novel approach targeting mouth dryness- when other factors were ruled out by measuring outcome on the halitosis questionnaire.

We will treat mouth dryness with Caphosol- a solution indicated for mouth dryness acting only locally after mouth washing. As this is a supersaturated phosphate solution of a mineral not alien to the body side effects are practically negligible.

Quality of life (QOL) questionnaires (such as SNOT20- sinonasal outcome test) are common in medicine, however no such questionnaire exists for halitosis. We devised a specific QOL questionnaire for halitosis. This questionnaire consists of 20 questions covering functional limitation, physical discomfort, psychological discomfort, physical disability and social disability. The answers will be based on a common scale of 5 answers depending on the severity and ranging from a never bothering symptom to a symptom which as worse as can be. Formulation of this a questionnaire can assist in measuring subjective halitosis with change observed over time or with intervention.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients complaining of halitosis
  • Patients over 18
  • Patients with dry mouth as seen on physical examinations
  • Patients that may be suffering from Sjogren's syndrome will be screened by SSB/La blood test.

排除标准

  • Patients without any other noted causes contributing to halitosis.
  • Patients restricted to a low sodium diet without specific permission from the treating physician.
  • Patients not wishing to participate in the study will be asked to fill the questionnaire regardless

结局指标

主要结局

Evaluation of Caphosol in treating Halitosis

时间窗: 1 month

次要结局

  • Confirmation of QOL questionnaire as tool measuring the burden of halitosis(1 month)

研究者

发起方
New York Head & Neck Institute
申办方类型
Other

研究点 (1)

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