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Completed

NCT Number: NCT05607043

Rutgers Pilot for 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)

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Key information

Conditions

SARS-CoV2 Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers School of Dental Medicine

Newark, New Jersey, 07103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Previous participation

Treatment and study plan

Testing for SARS CoV2 RNA

Device

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

Primary outcomes

  1. 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

  2. Willingness/Ability to Follow Through With the Study With Surveys, Triage and Testing

    Time frame: 26 days

    Percentage of patients who complete the study

  3. Patient Test Completion

    Time frame: Day 1

    Percentage of patients with completed SARS-CoV-2 testing

  4. 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

  5. Ease of Complying With Protocol

    Time frame: Day 26

    Number of participants indicating that it was easy to complete the surveys

  6. 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

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 7, 2022
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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