Rutgers Pilot for PREDICT- Patient LAB Test

September 13, 2023 updated by: Cecile A. Feldman, DMD, Rutgers, The State University of New Jersey

Rutgers Pilot for Pragmatic Return to Effective Dental Infection Control Through Triage and Testing (PREDICT)- Patient LAB 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 RNA using an FDA approved RT-PCR test for SARS-CoV2- an RNA RT-PCR assay (Accurate Diagnostics)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Rutgers School of Dental Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Device: Testing for SARS CoV2 RNA
Device: Testing for SARS CoV2 RNA- lab-based RNA RT-PCR testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Willingness to Participate in the Study
Time Frame: Day 1
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
Time Frame: 26 days
Percentage of patients who complete the study
26 days
Patient Test Completion
Time Frame: Day 1
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
Time Frame: From initial consent through study completion- approximately 4 weeks
Percentage of subjects completing study activities within the defined optimal window
From initial consent through study completion- approximately 4 weeks
Percent of Patients Who Completed All of the Required Surveys
Time Frame: 1 week
Percentage of patients participating in the study who completed pre-visit, triage and post-visit surveys
1 week
Ease of Complying With Protocol
Time Frame: Day 26
Number of participants indicating that it was easy to complete the surveys
Day 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

  • Principal Investigator: Cecile A Feldman, Rutgers School of Dental Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2021

Primary Completion (Actual)

February 25, 2021

Study Completion (Actual)

February 25, 2021

Study Registration Dates

First Submitted

October 31, 2022

First Submitted That Met QC Criteria

October 31, 2022

First Posted (Actual)

November 7, 2022

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro2020002999
  • X01DE030407 (Other Identifier: NIDCR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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