Stopped: The study initially aimed to measure droplets; however, as more was learned about COVID transmission, it became apparent that aerosol should be measured, but the method to measure aerosol was not possible for this study, so the study was withdrawn.
0Started 2021-11-01
Plain-language summary
The purpose of this study is to collect, measure, and assess the environmental spatter produced during dental appointments under different isolation methods used in pediatric dentistry, to compare the effectiveness of aerosol reduction between these methods, to identify the most effective way to manage aerosol during dental prophylaxis for pediatric patients and to provide clinical evidence to facilitate practice guidelines in dentistry related to COVID-19.
Who can participate
Age range
4 Years – 15 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:
* ASA 1 patients
* Receiving dental prophylaxis or restorative procedure not requiring sedation or nitrous oxide
* Ability to cooperate in the dental chair
* Parents speak/read either English or Spanish and consent to study
* Child, when age appropriate, can assent to study
Exclusion Criteria:
* Patients that do not meet the above criteria (including inability to cooperate or special health care need)
* Parents that do not speak/read either English or Spanish
* Children that do not assent (when age appropriate) 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
1
To collect, measure, and assess the environmental spatter produced during dental appointments under different isolation methods used in pediatric dentistry
Timeframe: Through case completion, an average a year
Trial details
NCT IDNCT04430387
SponsorThe University of Texas Health Science Center, Houston