CompletedNot Applicable

Prevention of Enamel Demineralization by Use of K18-smooth Surface Sealant

United States16 participantsStarted 2018-01-08

Plain-language summary

This study will evaluate effectiveness of a urethane dimethacrylate (UDMA)-quaternary ammonium methacrylate (K18) resin (UDMA-K18) smooth surface sealant to prevent biofilm attachment to tooth surfaces thereby eliminating the possibility for the tooth to be demineralized. The hypothesis is that UDMA-K18 containing smooth surface sealant will be more effective at reducing enamel demineralization than the UDMA control or no treatment.

Who can participate

Age range

12 Years – 89 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: * Orthodontic patients at the Department of Orthodontics Clinic, School of Dental Medicine, University of Colorado who agree to consent to this study. * Orthodontic treatment plans that include fixed appliances from the second premolar to second premolar in both arches. * Orthodontic treatment plans that include extractions of at least 3 bicuspids at about 1 month after bracket placement. * The patient has adequate oral hygiene Exclusion Criteria: * Evidence of decalcification or restorations on any of the premolars planned for extraction prior to orthodontic treatment, * Pregnant women (self reported) * Any condition that contraindicates orthodontic treatment, * Not willing to consent to the study.

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

Change in Mineral Density Determined by the Canary Caries Detection System

Timeframe: Visit Window: 3-4 weeks.

Trial details

NCT IDNCT03306433

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12-07

Results submitted2021-05-12

View on ClinicalTrials.gov More Dental Caries trials