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.
1This trial tested a whitening toothpaste using an intraoral appliance model and measured enamel hardness recovery — since the study is already completed, has the data been published, and could my dentist review the results to see if this type of toothpaste might be relevant to my dental care?
2The trial measured something called Percent Surface Microhardness Recovery over three 9-day test periods — can you explain what that means in practical terms, and whether recovering enamel hardness is something that matters for my specific cavity situation?
3The study also tracked how much fluoride was absorbed into the enamel after using the whitening toothpaste — given that I have dental caries, is fluoride uptake from a toothpaste like this something worth considering, or are there more established fluoride treatments you'd recommend first?
4Since this was a completed lab-style model study rather than a large clinical trial testing patient outcomes, does that limit how much we can conclude about whether this whitening toothpaste is actually safe and effective for someone with my level of tooth decay?
5Are there standard cavity prevention or remineralization treatments I should be trying now, and how would a product like the one tested in this study fit alongside those options, if at all?
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)