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Rutgers Pilot for PREDICT- Patient LAB Test

Sponsor
Rutgers, The State University of New Jersey (Other)
Overall Status
Completed
CT.gov ID
NCT05607043
Collaborator
National Institute of Dental and Craniofacial Research (NIDCR) (NIH)
11
Enrollment
1
Location
1
Arm
21
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Device: Testing for SARS CoV2 RNA
 N/A

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.

Overall, 11 subjects with upcoming appointment at the Oral Medicine clinic, Rutgers School of Dental Medicine, with no history of documented COVID-19 infection or viral exposure, were enrolled in the study that interrogated patients' perceptions of safety and feedback regarding their testing experience. All 11 patients expressed initial interest, however, only 10 patients completed informed consent and submitted their saliva samples for testing. 9 patients completed all the steps of the pilot study.

Study Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Pilot study to assess feasibility of testing asymptomatic dental patients for SARS-CoV-2 antigen using lab-based RNA RT-PCR testingPilot study to assess feasibility of testing asymptomatic dental patients for SARS-CoV-2 antigen using lab-based RNA RT-PCR testing
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Rutgers Pilot for Pragmatic Return to Effective Dental Infection Control Through Triage and Testing (PREDICT)- Patient LAB Test
Actual Study Start Date :
Jan 31, 2021
Actual Primary Completion Date :
Oct 31, 2022
Actual Study Completion Date :
Oct 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Patient willingness to participate in the study [Day 1]

    Ratio of patients consenting to patients approached

  2. Willingness/Ability to follow through with the study with surveys, triage and testing [Day 1]

    Percentage of patients who complete the study

  3. Patient Test completion [Day 1]

    Percentage of patients with completed SARS-CoV-2 testing

  4. Percentage of activities occurring within the defined window for patients [Through study completion (average of 3 months)]

    Percentage of activities occurring within the defined window for patients

  5. Ease of complying with protocol [Day 1]

    Questions on survey asking how easy it was to complete the start of study, end of study surveys

  6. Percent of surveys completed by patients [Through study complet]

    Percentage of patients with complete pre-visit, triage and post-visit surveys completed

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Adult 18 years or older; reporting to the Rutgers School of Dental Medicine for a dental visit
Exclusion Criteria:
  • Previous participation

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rutgers School of Dental Medicine Newark New Jersey United States 07103

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Cecile A. Feldman, DMD, Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT05607043
Other Study ID Numbers:
  • Pro2020002999
  • X01DE030407
First Posted:
Nov 7, 2022
Last Update Posted:
Nov 8, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Cecile A. Feldman, DMD, Professor, Rutgers, The State University of New Jersey
Screening
Lab-based testing
Asymptomatic patients
Perception of safety
Feasibility
Additional relevant MeSH terms:
Infections
COVID-19

Study Results

No Results Posted as of Nov 8, 2022