Intra Oral Appliance (IOA) Model Evaluating the Efficacy of Sensitive Toothpaste (NCT07419763) | Clinical Trial Compass
CompletedNot Applicable
Intra Oral Appliance (IOA) Model Evaluating the Efficacy of Sensitive Toothpaste
United States30 participantsStarted 2025-04-15
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: a fluoride-free negative control, a positive control with 0.243% sodium fluoride, and an investigational dentifrice containing 0.243% sodium fluoride, 5.0% potassium nitrate (KNO₃), and 20% sodium bicarbonate. Adult subjects wore acrylic palatal appliances containing demineralized enamel specimens for three 7-day treatment periods, each preceded by a 5-day fluoride-free washout. Primary outcomes were percent surface microhardness recovery (%SMHR) and 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 saliva flow (≥1.5 mL unstimulated saliva in 5 minutes)
* ≥16 teeth and functional maxillary dentition to support palatal appliance
* Agree to abstain from other oral care products and preventive dental procedures during study
* No advanced periodontal disease, no visible untreated caries
* If female, not pregnant or breastfeeding (self-reported)
* No significant oral soft tissue pathology; no peri/oral piercings; no removable partial dentures
* No antibiotics or immunosuppressives within 30 days of screening
* No palatal torus; no medical condition that would interfere with safety
* No allergy or significant adverse events to impression materials, acrylics, or common oral product
Exclusion Criteria:
* Unable to tolerate appliance or comply with procedures
* Oral pathology that interferes with participation
* Use of fluoride toothpaste during washout periods
* Participation in another appliance study within the last 4 week
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)
Timeframe: End of each 7-day test period (three periods total)
2
Enamel Fluoride Concentration (EFU)
Timeframe: End of each 7-day test period (three periods total)