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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.