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Active, Not Recruiting

NCT Number: NCT06194123

Effect of Whitening Agent With Emulsion Gel in Saliva and Halitosis

The objective of this study is to evaluate how well the study product, Crest Daily Whitening Serum, alleviates Xerostomia and perceived halitosis over 1 week of use.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years of age.
  • Can produce an unstimulated salivary flow rate of 0.18mL/min. or less.
  • Score of 3 or more on question 1 of the VAS dry mouth scale (How severe is your dryness right now?), evaluated in the Pre-Product Use Dry Mouth & Sensitivity Questionnaire.
  • Evidence of currently taking a stable dose (3 months or more) of Xerostomia-inducing medication such as, antihypertensives, anti-anxiety agents, psychiatric remedies, antihistamines and etc.
  • At screening, participants may present the prescription bottle, a picture of the prescriptions bottle or medical records showing the prescription.
  • Subject not currently using any teeth whitening or desensitizing products that contain potassium nitrate such as Sensodyne, Pronamel etc.
  • Subject willing to comply with the study regimen and products.
  • Not consume alcohol for 24 hours prior to their visit.
  • Not brush their teeth for 1.5 hours prior to their visit.
  • Not have had anything to eat or drink (including chewing gum or eating candy) for 1.5 hours prior to their visit). Water is acceptable to drink up to 1 hour prior to the study visit.
  • Not smoke 1.5 hours prior to their visit

Exclusion criteria

i. Subjects who are currently pregnant (self-reported). ii. Unstimulated salivary flow rate of more than 0.18mL/min iii. Subjects that have ever received therapeutic radiation in the head and neck area.

iv. Subjects with a diagnosis of conditions that would affect salivary flow such as Sjogren's Syndrome per the investigator's expert opinion.

v. Subjects with a condition the investigator believes not suitable for the study, such as autoimmune diseases and radiation therapy to head and neck region that impact salivary flow.

vi. Subjects that currently use whitening toothpaste, desensitizing toothpaste, or any other products causing similar results.

vii. Subjects currently participating in any other research studies. viii. Subject unable to provide consent (e.g. Cognitively impaired adults). ix. Non-English speaking

Treatment and study plan

Crest Daily Whitening Serum

Other

one week's use of Crest Daily Whitening Serum as described on the label.

Primary outcomes

  1. Objective 1- Visual Analogue Scale for Perceived Dry Mouth

    Time frame: 5, 30, 60 minute post application of product as well as degree of change after a 7 day period of use.

    To observe presence and degree of reduction in the self-reported subjective perception of dryness in the oral cavity at different time intervals after the application of a Whitening Agent with Emulsion Gel in Xerostomic Population

Secondary outcomes

  1. Objective 2- Visual Analogue Scale for Perceived Bad Breath and Saliva Production Increase

    Time frame: 60 minutes post application as well as degree of change after a 7 day period of use.

    To measure presence and degree of reduction of self-reported bad breath and subject's objective measurement of how well saliva production improved on a 1-10 scale at different time intervals with a Whitening Agent with Emulsion Gel in Xerostomic Population

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2027
First posted
Jan 8, 2024
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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