N/A N=25 Treatment

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

Xerostomia

Bottom Line

View on ClinicalTrials.gov: NCT04996069 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2024

Primary outcome: Primary: Subjective Perception of Mouth Dryness — 6.92; 6.46; 4.21; 3.46 units on a scale — p=.45

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Crest Whitening Emulsions (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Tufts University
Primary completion: Apr 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Subjective Perception of Mouth Dryness	6.92; 6.46; 4.21; 3.46	.45
SECONDARY Change in Saliva Production Measured in ml/Min	0.06; 0.19; 0.14; 0.21	—
SECONDARY Perceived Sensitivity of Teeth Between Visit 1 and 2	3.61; 3.72; 2.30; 1.56	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04996069). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.