Clinical trial NCT05607043: Rutgers Pilot for PREDICT- Patient LAB Test
Official title: Rutgers Pilot for Pragmatic Return to Effective Dental Infection Control Through Triage and Testing (PREDICT)- Patient LAB Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SARS-CoV2 Infection
Keywords: Screening
Lab-based testing
Asymptomatic patients
Perception of safety
Feasibility
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2022-11-07
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study to assess feasibility of testing asymptomatic dental patients for SARS-CoV-2 antigen using lab-based RNA RT-PCR testing
Primary purpose: OTHER

Brief summary: 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)

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adult 18 years or older; reporting to the Rutgers School of Dental Medicine for a dental visit

Exclusion Criteria:

* Previous participation

Primary outcomes:
measure: Patient Willingness to Participate in the Study
timeFrame: Day 1
measure: Willingness/Ability to Follow Through With the Study With Surveys, Triage and Testing
timeFrame: 26 days
measure: Patient Test Completion
timeFrame: Day 1
measure: Percentage of Subjects Who Complete Study Activities to Optimize Gap Between Testing and Study Visit
timeFrame: From initial consent through study completion- approximately 4 weeks
measure: Ease of Complying With Protocol
timeFrame: Day 26
measure: Percent of Patients Who Completed All of the Required Surveys
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Rutgers School of Dental Medicine
state: New Jersey
Study officials:
affiliation: Rutgers School of Dental Medicine
name: Cecile A Feldman
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.