Effect of Whitening Agent With Emulsion Gel in Saliva and Halitosis (NCT06194123) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effect of Whitening Agent With Emulsion Gel in Saliva and Halitosis
United States27 participantsStarted 2024-02-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 f…
What they're measuring
1
Objective 1- Visual Analogue Scale for Perceived Dry Mouth
Timeframe: 5, 30, 60 minute post application of product as well as degree of change after a 7 day period of use.