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临床试验/NCT04996069
NCT04996069已完成不适用

Exploratory Study on Effect of Whitening Agent With Emulsion Gel in Xerostomic Population

Tufts University2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年8月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Subjective Perception of Mouth Dryness

研究概览

简要总结

Xerostomia, is a subjective sensation of dryness of the mouth. There are more than 700 medications that can lead to the salivary hypofunction that results in dry mouth. This study will investigate a semi solid cohesive gel (referred to as Whitening Gel) that has the primary marketed purpose of teeth whitening. We theorize that the whitening gel's retention in the oral cavity is longer than rinse forms and this is likely to promote the flow of saliva by stimulating taste buds which could alleviate the sensation of dryness in the oral cavity. This will be a single center, two visit study investigating the effectiveness of dryness in the oral cavity, whiteness of teeth, and teeth sensitivity after one week's use of whitening agent.

详细描述

Aims:

  • Primary aim: To see a reduction in the self-reported subjective perception of dryness in the oral cavity.
  • Secondary aims: To measure self-reported sensitivity of the teeth,. self-reported perception of teeth whiteness, and objective measurement of improvement of saliva production.

Background and Rationale:

Xerostomia, is a subjective sensation of dryness of the mouth, which may have a significant effect in a persons quality of life. The sensation of dryness of the mouth may be caused by autoimmune diseases which attack the saliva producing glands irreversibly e.g., salivary glands, or the sensation of dryness could be caused by therapeutic radiation, which can destroy the salivary glands at the genetic level and impede their functions. Additionally, there are more than 700 medications including antihypertensives, anti-anxiety agents, psychiatric remedies, and antihistamines that can effect neural transmission. Neural transmission is when the neuro transmission is hindered reversibly leading to the salivary hypofunction that results in dry mouth. It is estimated that 12-47% of the elderly and 10-19.3% in their early 30's suffer from dry mouth (Thomson et al 2005)(Guggenheimer et al 2003). In a study, it was found that the prevalence of xerostomia was 10.0% (with no apparent gender difference) among 32-year-olds and was significantly higher among those taking antidepressants (odds ratio =4.7) (Murray et al 2006). At risk groups may present much higher (60+%) rates of xerostomia. A systemic literature review suggests a prevalence of 27 -32% of the medicated population suffer from xerostomia as a side effect (Guggenheimer et al 2003).

Saliva, the bulk fluid of the oral cavity is very important in maintaining the functions and balance in the oral cavity including candidiasis and enamel erosion prevention. In past studies, residual mucosal fluid levels were seen to vary in different oral cavity sites from an average of 70-100 μm (Collins et al 1987)(Pramanik et al 2010). In addition, the vault of the hard palate has much less mucosal fluid thickness than the floor of the mouth. Over the moisture layer is the lipid layer and reduction or loss of this moisture layer can contribute to the subjective perception of the dryness in the mouth. An addition of the lipid layer will also increase lubrication in the oral cavity.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

This will be an open label study; thus no randomization plan is necessary.There will be no blinding for this study

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

  • At least 18 years of age.
  • The inability to produce more than 0.18mL/min of unstimulated saliva.
  • Score of 5 or more in the VAS dry mouth scale, evaluated in the mouth feel questionnaire.
  • Evidence of currently taking Xerostomia-inducing medication such as, antihypertensives, anti-anxiety agents, psychiatric remedies, antihistamines.
  • Subject not currently using any teeth whitening or desensitizing products that contain potassium nitrate such as Sensodyne or Pronamel.
  • Subject willing to comply with the study regimen and products.
  • Exclusion Criteria
  • Subjects who are currently pregnant (self-reported).
  • Subjects able to produce more than 0.18mL/min of unstimulated saliva
  • Subjects that have ever received therapeutic radiation in the head and neck area.
  • Subjects with a diagnosis of conditions that would affect salivary flow such as Sjogren's Syndrome.
  • Subjects with a condition the investigator believes not suitable for the study such as autoimmune diseases that impact salivary flow.
  • Subjects that currently use whitening toothpaste, desensitizing toothpaste, or any other products causing similar results.
  • Subjects currently participating in any other research studies.
  • Subject unable to provide consent (ex. Cognitively impaired adults).
  • Non-English speaking

排除标准

  • 未提供

结局指标

主要结局

Subjective Perception of Mouth Dryness

时间窗: visit 1 and visit 2 pre and post product application on Day 1 and day 7

At both study visits, subjects will be asked to complete a visual analog scale (VAS) before and after the application of the study product to establish a self-reported subjective perception of the oral cavity. The scale ranges from 0 to 10 and the higher the score indicates the more Xerostomic the subject.

次要结局

  • Change in Saliva Production Measured in ml/Min(visit 1 and visit 2 pre and post saliva production in day 1 and day 7)
  • Perceived Sensitivity of Teeth Between Visit 1 and 2(7 days between visit 1 and visit 2)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mabi Singh

Associate Professor, Diagnostic Sciences

Tufts University

研究点 (2)

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