Effect of Whitening Agent With Emulsion Gel in Saliva and Halitosis

Last updated: April 7, 2025
Sponsor: Tufts University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Dry Mouth

Saliva And Salivary Gland Dysfunction

Treatment

Crest Daily Whitening Serum

Crest Whitening Emulsions

Clinical Study ID

NCT06194123
4475
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 yourdryness right now?), evaluated in the Pre-Product Use Dry Mouth & SensitivityQuestionnaire.

  • Evidence of currently taking a stable dose (3 months or more) of Xerostomia-inducingmedication such as, antihypertensives, anti-anxiety agents, psychiatric remedies,antihistamines and etc.

• At screening, participants may present the prescription bottle, a picture of theprescriptions bottle or medical records showing the prescription.

  • Subject not currently using any teeth whitening or desensitizing products thatcontain 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 hourprior to the study visit.

  • Not smoke 1.5 hours prior to their visit

Exclusion

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

Study Design

Total Participants: 27
Treatment Group(s): 2
Primary Treatment: Crest Daily Whitening Serum
Phase:
Study Start date:
February 01, 2024
Estimated Completion Date:
February 01, 2026

Connect with a study center

  • Tufts University School of Dental Medicine

    Boston, Massachusetts 02111
    United States

    Site Not Available

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