Rutgers Pilot for PREDICT- Patient LAB Test

SARS-CoV2 Infection Clinical Trial

Official title:

Rutgers Pilot for Pragmatic Return to Effective Dental Infection Control Through Triage and Testing (PREDICT)- Patient LAB Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05607043
• Other study ID #: Pro2020002999
• Secondary ID: X01DE030407
• Status: Completed
• Phase: N/A
• Start date: January 31, 2021
• Est. completion date: February 25, 2021

Study information

• Verified date: September 2023
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 25, 2021
• Est. primary completion date: February 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Previous participation

Related Conditions & MeSH terms

• COVID-19
• Infections
• SARS-CoV2 Infection

Intervention

Device:
• Testing for SARS CoV2 RNA
Device: Testing for SARS CoV2 RNA- lab-based RNA RT-PCR testing

Locations

Country	Name	City	State
United States	Rutgers School of Dental Medicine	Newark	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. Erratum In: J Am Dent Assoc. 2021 Sep;152(9):719. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Willingness to Participate in the Study	Percentage of 36 patients who were approached to enroll in the study who actually enrolled	Day 1
Primary	Willingness/Ability to Follow Through With the Study With Surveys, Triage and Testing	Percentage of patients who complete the study	26 days
Primary	Patient Test Completion	Percentage of patients with completed SARS-CoV-2 testing	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	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	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	1 week