Cold Plasma for Dental Restoration and Caries Prevention (NCT01529606) | Clinical Trial Compass
CompletedNot Applicable
Cold Plasma for Dental Restoration and Caries Prevention
United States102 participantsStarted 2012-09
Plain-language summary
The main objective of this entire research project is to develop a miniature atmospheric cold plasma brush (m-ACPB) for dental clinical applications. The objective of the clinical trial portion of the study is to compare the longevity and durability of dental composite restorations created using the plasma brush, to that of the standard care in dentistry for treating dental cavities, and effects on caries prevention.
Who can participate
Age range
18 Years – 35 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:
* subject must be Caucasian or Africa American, 18-35 years old, have written, completed, informed consent forms;
* be generally healthy;
* be able to participate in the study;
* have no diagnosed periodontitis and pericoronitis;
* have no active mucosal diseases such as aphthous ulcers and herpetic stomatitis.
They must also agree to follow study instructions.
The patients must meet the following specific entry criteria:
* 1-5 untreated caries and at least one class II caries.
Exclusion Criteria:
* each subject must have no diagnosed diabetes mellitus or any other endocrine diseases;
* no diagnosed cardiovascular diseases;
* no diagnosed immune-compromised diseases, such as HIV and AIDS;
* no other serious systemic diseases, such as cancer;
* no antibiotic therapy in the past 6 months;
* no use of non-steroidal anti-inflammatory drugs (NSAIDS) in the past 3 months; and
* no reported use of illicit drugs.
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
Number of Decayed, Missing and Filling Teeth (DMFT)