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

Completed · Not applicable

Conditions studied: Xerostomia

In brief

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.

Key facts

Study ID

NCT04996069

Run by

Tufts University

People needed

25

Starts

2021-08-09

Expected to finish

2022-04-26

Last updated by the study team

2024-07-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Tufts University School of Dental Medicine — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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