Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| X01DE030407 | Other Identifier | NIDCR |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
Not provided
Not provided
Not provided
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 RNA using an FDA approved RT-PCR test for SARS-CoV2- an RNA RT-PCR assay (Accurate Diagnostics)
Patients with upcoming dental appointments at the Oral Medicine clinic at Rutgers School of Dental Medicine were contacted to solicit interest in participating in a pilot study to assess feasibility of testing asymptomatic dental patients for SARS CoV 2 infection using an RNA RT-PCR assay. Interested subjects completed a previsit survey after confirming their interest electronically. Subsequently, they received kit to collect their saliva sample at home along with instructions on how to do so. They were directed to drop off their saliva samples for testing at the dental clinic and signed the consent form at that time. After confirming a negative result, the patients were subsequently triaged over the phone for any symptoms and the following day, presented for their dental visit.
On the day of their visit, they were triaged, completed their dental visit and were surveyed to get their feedback on the study procedures and their perceptions of safety.
Not provided
Not provided
Not provided
Not provided
| 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 infection as described. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testing for SARS CoV2 RNA | Device | Device: Testing for SARS CoV2 RNA- lab-based RNA RT-PCR testing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Willingness to Participate in the Study | Percentage of 36 patients who were approached to enroll in the study who actually enrolled | Day 1 |
| Willingness/Ability to Follow Through With the Study With Surveys, Triage and Testing | Percentage of patients who complete the study | 26 days |
| Patient Test Completion | Percentage of patients with completed SARS-CoV-2 testing | Day 1 |
| Percentage of Subjects Who Complete Study Activities to Optimize Gap Between Testing and Study Visit | Percentage of subjects completing study activities within the defined optimal window | From initial consent through study completion- approximately 4 weeks |
| Ease of Complying With Protocol | Number of participants indicating that it was easy to complete the surveys | Day 26 |
| Percent of Patients Who Completed All of the Required Surveys | Percentage of patients participating in the study who completed pre-visit, triage and post-visit surveys | 1 week |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | 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 |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
11 asymptomatic dental patients with upcoming appointments at the Oral Medicine clinic, Rutgers School of Dental Medicine, were enrolled. Study participation ranged from January- February 2021.
Not provided
| 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 infection as described. Testing for SARS CoV2 RNA: Device: Testing for SARS CoV2 RNA- lab-based RNA RT-PCR testing |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| 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 infection as described. Testing for SARS CoV2 RNA: Device: Testing for SARS CoV2 RNA- lab-based RNA RT-PCR testing |
| Units | Counts |
|---|---|
| Participants |
|
| 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 Participate in the Study | Percentage of 36 patients who were approached to enroll in the study who actually enrolled | 36 patients were approached to enroll in the study. The percentage of 36 patients who consented to participate in the study is tabulated | Posted | Number | percentage | Day 1 |
|
|
From signing initial consent to completion of study visit- approximately 4 weeks
This study involved a nasal swab, and a survey
Not provided
| 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 infection as described. Testing for SARS CoV2 RNA: Device: Testing for SARS CoV2 RNA- lab-based RNA RT-PCR testing |
Not provided
Not provided
Not provided
| 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 |
Not provided
| 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 | Sep 2, 2022 | Jul 12, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 11, 2021 | Jul 12, 2023 | ICF_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
Pilot study to assess feasibility of testing asymptomatic dental patients for SARS-CoV-2 antigen using lab-based RNA RT-PCR testing
Not provided
Not provided
Not provided
Not provided
| 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 |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Willingness/Ability to Follow Through With the Study With Surveys, Triage and Testing | Percentage of patients who complete the study | Posted | Count of Participants | Participants | 26 days |
|
|
|
| Primary | Patient Test Completion | Percentage of patients with completed SARS-CoV-2 testing | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Primary | Percentage of Subjects Who Complete Study Activities to Optimize Gap Between Testing and Study Visit | Percentage of subjects completing study activities within the defined optimal window | Posted | Number | participants | From initial consent through study completion- approximately 4 weeks |
|
|
|
| Primary | Ease of Complying With Protocol | Number of participants indicating that it was easy to complete the surveys | Posted | Count of Participants | Participants | Day 26 |
|
|
|
| Primary | Percent of Patients Who Completed All of the Required Surveys | Percentage of patients participating in the study who completed pre-visit, triage and post-visit surveys | Posted | Count of Participants | Participants | 1 week |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
Not provided
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |