Rutgers Pilot for PREDICT- Patient LAB Test

NCT ID: NCT05607043

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-31
• Study Completion Date: 2021-02-25

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.

Conditions

SARS-CoV2 Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Testing for SARS CoV2 RNA

Intervention Type: DEVICE

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

Interventions

Testing for SARS CoV2 RNA

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Cecile A. Feldman, DMD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cecile A Feldman

Role: PRINCIPAL_INVESTIGATOR

Rutgers School of Dental Medicine

Locations

Rutgers School of Dental Medicine

Newark, New Jersey, United States

Countries

United States

References

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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 33071007 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34176567 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

X01DE030407

Identifier Type: OTHER

Identifier Source: secondary_id

Pro2020002999

Identifier Type: -

Identifier Source: org_study_id