Intraoral Appliance (IOA) Model Evaluating the Efficacy of a Whitening Toothpaste (NCT07419685) | Clinical Trial Compass
CompletedNot Applicable
Intraoral Appliance (IOA) Model Evaluating the Efficacy of a Whitening Toothpaste
United States31 participantsStarted 2024-10-08
Plain-language summary
This single-center, randomized, double-blind, three-period crossover in situ study evaluated the enamel remineralization potential and fluoride bioavailability of three dentifrices-one fluoride-free negative control, one positive control with 0.243% sodium fluoride, and one investigational dentifrice containing 0.243% sodium fluoride and 20% sodium bicarbonate. Healthy adult subjects wore a palatal acrylic appliance containing demineralized enamel specimens for three 9-day treatment periods, during which in vivo brushing/slurry exposure and ex vivo sucrose challenges were performed. Outcomes included percent surface microhardness recovery (%SMHR) and post-treatment enamel fluoride concentration.
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:
* Adults ≥18 years
* Good general and oral health
* Normal unstimulated salivary flow (≥1.5 mL/5 min)
* Functional dentition
* Oral conditions adequate to support the palatal appliance
* Ability to comply with brushing, slurry, appliance wear, and sucrose challenge procedures
Exclusion Criteria:
* Inability to tolerate appliance
* Oral pathology that interferes with participation
* Antibiotic use that violates withdrawal criteria
* Use of fluoride toothpaste during washout
* Participation in another appliance study in the past 4 weeks
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
Percent Surface Microhardness Recovery (%SMHR) [Time Frame: End of each 9-day test period (three test periods in total)]
Timeframe: End of each 9#day test period (three test periods in total)