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| ID | Type | Description | Link |
|---|---|---|---|
| X01DE030407 | Other Identifier | NIDCR |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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A pilot study was initiated to assess feasibility of testing asymptomatic dental patients presenting to the Oral Medicine Clinic at Rutgers School of Dental Medicine for SARS-CoV-2 viral antigen using a point-of-care (POC) Rapid Antigen test.
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.
A pilot study was initiated to assess feasibility of testing asymptomatic dental patients presenting to the Oral Medicine Clinic at Rutgers School of Dental Medicine for SARS-CoV-2 viral antigen using a point-of-care (POC) Rapid Antigen test.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SARS-CoV-2 testing | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testing for SARS CoV2 Antigen | Device | Device: Testing for SARS CoV2 Antigen Antigen testing: Rapid Antigen testing (Point-of-care) |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient Willingness to Follow Through With the Study Surveys, Triage and Testing | Percentage of 14 patients who complete the study | Through study completion, an average of 21 days |
| Patient Test Completion | Percentage of 14 patients with completed SARS-CoV-2 testing | Day 1 |
| Patient Ease of Complying With Protocol | Number of participants indicating that it was easy to complete the surveys | Day 21 |
| Percentage of Surveys Completed by Patients | Percentage of patients with completed pre-visit, triage and post-visit surveys completed | Through study completion (21 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cecile A Feldman | Rutgers School of Dental Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers School of Dental Medicine | Newark | New Jersey | 07103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 33071007 | Background | 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. | |
| 34176567 |
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D: No If the COVID test results show that a participant is positive for COVID-19, the study staff will tell the participant the results. The study staff will be required to give the participant's name to the state's Department of Public Health if the participant tests positive because this is the law.
At the end of the study, de-identified data will be provided to the National Coordinating Center.
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14 asymptomatic dental patients with upcoming appointments at the Oral Medicine Clinic, Rutgers School of Dental Medicine, were enrolled. Study participation took place in between December 2020 and January 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Willingness to Follow Through With the Study Surveys, Triage and Testing | Percentage of 14 patients who complete the study | 14 patients enrolled in the study. The percentage of 14 patients who completed the study is tabulated | Posted | Number | percentage of participants | Through study completion, an average of 21 days |
|
|
From signing initial consent to completion of study- 21 days
This study involved a nasal swab and a survey
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gayathri Subramanian, PhD, DMD | Rutgers School of Dental Medicine, Newark, New Jersey, United States | 732 824 7241 | subramga@sdm.rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 17, 2022 | Oct 10, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 15, 2020 | Mar 2, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Pilot study to assess feasibility of testing asymptomatic dental patients for SARS-CoV-2 antigen using Rapid Antigen point-of-care testing
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| Background |
| 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. |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Counts |
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| Participants |
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| Primary | Patient Test Completion | Percentage of 14 patients with completed SARS-CoV-2 testing | Posted | Count of Participants | Participants | Day 1 |
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| Primary | Patient Ease of Complying With Protocol | Number of participants indicating that it was easy to complete the surveys | Posted | Count of Participants | Participants | Day 21 |
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| Primary | Percentage of Surveys Completed by Patients | Percentage of patients with completed pre-visit, triage and post-visit surveys completed | Posted | Count of Participants | Participants | Through study completion (21 days) |
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| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |