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Aerosol Evacuation Methods for Coronavirus in a Dental Clinic
Phase 4
Recruiting
Led By Aaron Glick, DDS, FAGD, FICOI, D.ABDSM
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
Summary
This trial will help researchers understand how effective mouth rinses and evacuation units are in preventing the spread of germs during dental procedures that create aerosols (fine sprays of water and other liquids). The study will also help researchers understand the risks that dental practitioners face when performing these procedures.
Who is the study for?
This trial is for dental patients who are having their first procedure of the day, which involves prepping natural teeth and lasts at least an hour. It aims to assess aerosol risks in a dental clinic during procedures that generate aerosols.
What is being tested?
The study is testing how effective different methods like external evacuation devices (EED), extraoral vacuum aspirators (EVA), high volume evacuations (HVE), and hydrogen peroxide mouth rinses are at reducing airborne particles during dental treatments.
What are the potential side effects?
Potential side effects may include discomfort from using the evacuation devices or mouth rinse. Hydrogen peroxide can sometimes cause irritation or white patches inside the mouth if used frequently.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: High volume evacuation (HVE) suction only and hydrogen peroxideExperimental Treatment2 Interventions
Group II: HVE suction and extraoral vacuum aspirator (EVA) and hydrogen peroxideExperimental Treatment3 Interventions
Group III: HVE suction and external evacuation device (EED) and hydrogen peroxideExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydrogen Peroxide
2017
Completed Phase 3
~1640
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
949 Previous Clinical Trials
344,975 Total Patients Enrolled
Aaron Glick, DDS, FAGD, FICOI, D.ABDSM5.04 ReviewsPrincipal Investigator - The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
5Patient Review
I have had several positive experiences at Stephens and Gatewood, so I decided to return for a cavity filling. Dr. Glick was my dentist this time, and I was so pleased with his manner. He explained the procedure beforehand, which put me at ease, and then he did a great job with the filling itself. He was quick and thorough, and I would recommend him to anyone.
Claudia Ruiz Brisuela, DDSPrincipal InvestigatorThe University of Texas Health Science Center, Houston
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The appointment involves preparing natural teeth.The procedure takes at least one hour to complete.
Research Study Groups:
This trial has the following groups:- Group 1: High volume evacuation (HVE) suction only and hydrogen peroxide
- Group 2: HVE suction and extraoral vacuum aspirator (EVA) and hydrogen peroxide
- Group 3: HVE suction and external evacuation device (EED) and hydrogen peroxide
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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