Status:
ACTIVE_NOT_RECRUITING
Effect of Whitening Agent With Emulsion Gel in Saliva and Halitosis
Lead Sponsor:
Tufts University
Conditions:
Xerostomia
Halitosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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
- 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
- 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
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2026
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT06194123
Start Date
February 1 2024
End Date
February 1 2026
Last Update
April 8 2025
Active Locations (1)
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1
Tufts University School of Dental Medicine
Boston, Massachusetts, United States, 02111