Study Results
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View full resultsBasic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2020-12-30
2022-10-31
Brief Summary
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14 subjects with upcoming appointment at the Oral Medicine clinic, Rutgers School of Dental Medicine, with no history of documented COVID-19 infection or viral exposure, were enrolled in a study that interrogated patients' perceptions of safety and feedback regarding their testing experience. All 14 patients expressed initial interest, however, 10 patients completed informed consent and completed study procedures.
Institutional Clinical Laboratory Improvement Amendments (CLIA) certification of waiver was obtained prior to conducting the study. Communicable Diseases Reporting and Surveillance System (CDRSS) registration and training were completed to enable reporting results of the POC test.
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Detailed Description
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14 subjects with upcoming appointment at the Oral Medicine clinic, Rutgers School of Dental Medicine, with no history of documented COVID-19 infection or viral exposure, were enrolled in a study that interrogated patients' perceptions of safety and feedback regarding their testing experience. All 14 patients expressed initial interest, however, 10 patients completed informed consent and completed study procedures on their appointments, the remaining 4 patients did not present for their appointment.
Following initial interest in participation over the phone, the subjects completed a pre-visit survey prior to their upcoming appointment. The day prior to their visit, a phone triage was completed and repeated as they checked in for their appointment. A nasal sample was collected and processed using the FDA EUA authorized Rapid Antigen Test BD Veritor Plus Analyzer, BD Sciences. An end-of-study survey was collected to assess patients' feedback about their experience and their perception of safety.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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SARS-CoV-2 testing
There is only one arm in this study- the study is a non-randomized pilot. All the subjects will be tested for SARS CoV 2 viral Antigen as described.
Testing for SARS CoV2 Antigen
Device: Testing for SARS CoV2 Antigen Antigen testing: Rapid Antigen testing (Point-of-care)
Interventions
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Testing for SARS CoV2 Antigen
Device: Testing for SARS CoV2 Antigen Antigen testing: Rapid Antigen testing (Point-of-care)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients unwilling to have their de-identified data made available to researchers
18 Years
99 Years
ALL
Yes
Sponsors
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National Institute of Dental and Craniofacial Research (NIDCR)
NIH
Rutgers, The State University of New Jersey
OTHER
Responsible Party
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Cecile A. Feldman, DMD
Professor
Principal Investigators
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Cecile A Feldman
Role: PRINCIPAL_INVESTIGATOR
Rutgers School of Dental Medicine
Locations
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Rutgers School of Dental Medicine
Newark, New Jersey, United States
Countries
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References
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1. American Dental Association COVID-19 Toolkit - Update to Office Procedures During COVID-19. https://www.ada.org/-/media/project/ada-organization/ada/ada-org/files/resources/coronavirus/update_to_office_procedures_during_covid19.pdf accessed on November 11, 2021.
Estrich CG, Mikkelsen M, Morrissey R, Geisinger ML, Ioannidou E, Vujicic M, Araujo MWB. Estimating COVID-19 prevalence and infection control practices among US dentists. J Am Dent Assoc. 2020 Nov;151(11):815-824. doi: 10.1016/j.adaj.2020.09.005.
Shirazi S, Stanford CM, Cooper LF. Testing for COVID-19 in dental offices: Mechanism of action, application, and interpretation of laboratory and point-of-care screening tests. J Am Dent Assoc. 2021 Jul;152(7):514-525.e8. doi: 10.1016/j.adaj.2021.04.019. Epub 2021 May 4.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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X01DE030407
Identifier Type: OTHER
Identifier Source: secondary_id
Pro2020002998
Identifier Type: -
Identifier Source: org_study_id
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