PREDICT: A PBRN Feasibility Study on COVID-19 Screening in Dental Practice

NCT05123742 | Completed Results

• 3 other identifiers: Pro2021000968IRB-300007026U01DE028727
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The study team will conduct a feasibility study to develop and test out procedures for improved triage and COVID-19 testing in dental practices to increase safety and perceptions of the safety of Dental Health Care Workers (DHCW) and their patients. DHCWs in offices with Practice-Based Regional Network (PBRN) members and their patients will be recruited to participate in one of two protocols. The first, point-of-care (POC), will test out procedures for point-of-care SARS-CoV-2 antigen testing in the dental office along with enhanced triage using pulse oximeters. The second, laboratory (LAB), will test out procedures for a saliva-based laboratory SARS-CoV-2 viral test along with enhanced triage. The feasibility of implementing COVID-related testing and enhanced triage procedures in the dental setting will provide preliminary data to inform a larger network-wide study grant application.

Conditions

COVID-19 Infection

Keywords

dental health care; antibody test; antigen test; dental practice environment; COVID-19 screening; point of care testing; lab-based testing; dental offices; pragmatic design

Outcome Measures

Primary Outcomes (1)

• Perception of Safety

  Participants perception of safety in the dental office. Outcome measure is a score on a scale from 0 to 100 where 0=has unsafe as one can possibly feel and 100=as safe as one can possibly feel. All participants (DHCW and patients) were asked to indicate how safe they would feel seeking dental care if all dental office workers, but not patients, were regularly tested: how safe they would feel seeking care if all patients, but not dental care workers, were tested prior to their dental appointments; and how safe they would feel seeking dental care if all dental workers were regularly tested AND all patients were tested prior to their dental appointments.

  For DHCW at Day 28 (+/- 14 days), For Patients at their dental visit (day 1)

Secondary Outcomes (2)

• Specimen Preference

  For DHCWs at Day 28 (+/- 13 days); For patients at the time of their dental visit (Day 1)

• Testing Protocol Preference

  For DHCWs at Day 28 (+/- 14 days); For Patients at time of their dental visit (Day 1)

Study Arms (2)

DHCW Subjects

Dental Health Care Workers

Diagnostic Test: COVID-19 Testing

Patient Subjects

Dental patients

Diagnostic Test: COVID-19 Testing

Interventions

COVID-19 Testing DIAGNOSTIC_TEST

Testing for the SARS-CoV-2 virus

DHCW Subjects; Patient Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female dental health care workers and patients who are seen in a Practice-Based Research Network dentist office.

You may qualify if:

• A Dental Health Care Worker must meet all of the following criteria to be eligible to participate in the study:
• Be 18 years or older
• Be a National Dental PBRN member dentist or work in a dental office with a National Dental PBRN member dentist who consents to study participation
• Be able to understand the informed consent.
• Provide signed and dated informed consent form
• Be able to understand all instructions for data collection instruments
• Be willing and able to comply with all study procedures, including COVID-19 testing, and be available for the duration of the study
• A Patient must meet all of the following criteria to be eligible to participate in the study:
• Be 18 years or older
• Be able to understand the informed consent.
• Have a computer or electronic tablet with internet access
• Able to complete consent and questionnaire on a computer or electronic tablet
• Provide signed and dated informed consent form
• Be able to understand all instructions for data collection instruments
• Be willing and able to comply with all study procedures, including having a COVID-19 test performed

You may not qualify if:

• Children less than 18 years will not be able to participate.
• Participants would be excluded if they participated in the feasibility study previously conducted at Rutgers University.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator
• The National Dental Practice-Based Research Network: collaborator
• Kaiser Foundation Research Institute: collaborator
• University of Alabama at Birmingham: collaborator
• University of Rochester: collaborator
• University of Illinois at Chicago: collaborator

Study Sites (1)

Rutgers School of Dental Medicine

Newark, New Jersey, 07101, United States

Location

Related Publications (3)

• Fredericks-Younger J, Feldman CA, Allareddy V, Funkhouser E, McBurnie M, Meyerowitz C, Ragusa P, Chapman-Greene J, Coker M, Fine D, Gennaro ML, Subramanian G. Pragmatic Return to Effective Dental Infection Control through Triage and Testing (PREDICT): an observational, feasibility study to improve dental office safety. Pilot Feasibility Stud. 2024 Feb 28;10(1):44. doi: 10.1186/s40814-024-01471-x.

  PMID: 38419131 DERIVED

• Fredericks-Younger J, Feldman C, Allareddy V, Funkhouser E, McBurnie M, Meyerowitz C, Ragusa P, Chapman-Greene J, Coker M, Fine DH, Gennaro ML, Subramanian G. Pragmatic Return to Effective Dental Infection Control through Triage and Testing (PREDICT): A feasibility study to improve dental office safety. Res Sq [Preprint]. 2023 Sep 7:rs.3.rs-3011647. doi: 10.21203/rs.3.rs-3011647/v1.

  PMID: 37720040 DERIVED

• Fredericks-Younger J, Fine DH, Subramanian G, Coker MO, Meyerowitz C, Ragusa P, Allareddy V, McBurnie MA, Funkhouser E, Gennaro ML, Feldman CA. The Pragmatic Return to Effective Dental Infection Control Through Triage and Testing (PREDICT) Study: Protocol for a Prospective Clinical Study in the National Dental Practice-Based Research Network. JMIR Res Protoc. 2022 Aug 31;11(8):e38386. doi: 10.2196/38386.

  PMID: 35944181 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biospecimens - saliva sample, tongue swab, nasal swab specimen, and capillary blood sample

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Testing

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Results Point of Contact

• Title: Cecile A. Feldman, DMD, MBA
• Organization: Rutgers School of Dental Medicine

feldman@sdm.rutgers.edu

9739724634

Study Officials

• Cecile Feldman, DMD

  Rutgers School of Dental Medicine

  PRINCIPAL INVESTIGATOR

• Janine Fredericks-Younger, DMD

  Rutgers School of Dental Medicine

  PRINCIPAL INVESTIGATOR

• Modupe Coker, PhD

  Rutgers School of Dental Medicine

  PRINCIPAL INVESTIGATOR

• Daniel Fine, DMD

  Rutgers School of Dental Medicine

  PRINCIPAL INVESTIGATOR

• Gayathri Subramanian, DMD

  Rutgers School of Dental Medicine

  PRINCIPAL INVESTIGATOR

• Maria Gennaro, PhD

  Rutgers University

  PRINCIPAL INVESTIGATOR

• Cyril Meyerowitz, DDS

  University of Rochester

  STUDY DIRECTOR

• Veerasathpurush Allareddy, PhD

  University of Illinois at Chicago

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Dean, Rutgers School of Dental Medicine

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 17, 2021
• Study Start: December 13, 2021
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 5, 2023
• Results First Posted: October 5, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)