COVID-19 InfectionPREDICTNCT05123742
PREDICT: A PBRN Feasibility Study on COVID-19 Screening in Dental Practice
An observational study of COVID-19 Infection, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Infection
- What is being tested?
- COVID-19 Testing
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male and female dental health care workers and patients who are seen in a Practice-Based Research Network dentist office.
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers School of Dental Medicine
Newark, New Jersey, 07101
About this study
Official title: Pragmatic Return to Effective Dental Infection Control Through Triage and Testing (PREDICT): A PBRN Feasibility Study on COVID-19 Screening in Dental
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.
Read the detailed description
Data derived from this research would enable dental health care workers to return to work, providing essential oral health care services in the safest possible environment. It will provide patients with confidence that they could resume seeking dental care under optimal conditions that ensure their well-being. The specific aims of this proposal are divided into three parts. The first aim is to apply the Delphi methodology, selecting a facilitator, a panel of experts, defining the problem, addressing the problem with several iterations, and coming to a consensus solution. The second aim is will address the concerns and recommended solutions proposed by the Delphi group and formulated into pragmatic improvements that can be applied to improved practice procedures that can be formulated into testable hypotheses that can be incorporated into a practice strategy for the future of dentistry. Pragmatic and novel methodological changes developed by the investigative team will be presented once again to the Delphi group to gain their approval and/or recommended modifications. Our overarching goal is to test these "improved" strategies in a pilot study and as such the investigators are looking to incorporate two to three methodological suggestions that can be fit into a pragmatic re-design of "best dental practices". Thus, the third aim is designed to test these "best dental practice" approaches in a pilot study. The goal of the third aim is to evaluate how each of these strategies can be applied to different office settings. The data derived from this approach will be used to provide a sample size calculation for a larger study using the PBRN framework for office participation. The all-encompassing aim of the study is to develop a new way of approaching dental practice that ensures a sense of security and practicality for both patients and health professionals. The hypothesis to be tested derived from these aims relates to the structured development of several methodologies that can be applied to dental practice. These methodologic improvements in dental practice will be based on the most current scientific knowledge that can be applied to ensure safety in a dental office setting. To re-iterate the purpose of this study developed from the three aims proposed is to assess and compare each of the pragmatic models developed such that a sample size calculation can be computed. The pilot study design and the sample size calculation derived from this pilot data will compare two to three pragmatic/innovative modifications in the current practice guidelines and provide an estimate that can utilize the larger PBRN framework to best determine the generalizability of the models chosen for study.
- Conditions
- COVID-19 Infection
- Being tested
- COVID-19 Testing
- 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
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 TestingDiagnostic test
Testing for the SARS-CoV-2 virus
| Study group | Role | What they receive |
|---|---|---|
| DHCW Subjects | Dental Health Care Workers Receives: Diagnostic Test: COVID-19 Testing | |
| Patient Subjects | Dental patients Receives: Diagnostic Test: COVID-19 Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: For DHCW at Day 28 (+/- 14 days), For Patients at their dental visit (day 1)
Secondary outcomes (2)
Specimen Preference
Ranking of the type of specimen participants preferred. Outcome measure is a score on a scale from 1 to 6 where 1=the most preferred specimen type and 6 the least preferred specimen type. Scores could not be used twice providing a ranking of specimen preference.
Measured: For DHCWs at Day 28 (+/- 13 days); For patients at the time of their dental visit (Day 1)
Testing Protocol Preference
COVID-19 testing method preferred by subjects. Outcomes measure is a score on a scale where testing protocols are ranking from 1 to 4 with 1 being the most preferred method and 4 is the least preferred method. Score could not be used twice with the scores indicating the subject's testing preference.
Measured: For DHCWs at Day 28 (+/- 14 days); For Patients at time of their dental visit (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start13 Dec 2021
- Primary completion31 Oct 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), The National Dental Practice-Based Research Network, Kaiser Foundation Research Institute, University of Alabama at Birmingham, University of Rochester, University of Illinois at Chicago
- Responsible party
- Principal investigator, Cecile A. Feldman, DMD, Rutgers, The State University of New Jersey
- Investigators
- Cecile Feldman, DMD, Principal investigator, Rutgers School of Dental MedicineJanine Fredericks-Younger, DMD, Principal investigator, Rutgers School of Dental MedicineModupe Coker, PhD, Principal investigator, Rutgers School of Dental MedicineDaniel Fine, DMD, Principal investigator, Rutgers School of Dental MedicineGayathri Subramanian, DMD, Principal investigator, Rutgers School of Dental MedicineMaria Gennaro, PhD, Principal investigator, Rutgers UniversityCyril Meyerowitz, DDS, Study director, University of RochesterVeerasathpurush Allareddy, PhD, Study director, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123742
- Sponsor's protocol ID
- Pro2021000968
- Other IDs
- IRB-300007026, U01DE028727
- Acronym
- PREDICT
- Status last verified
- Sep 2023
- First submitted
- 20 Oct 2021
- Last updated
- 5 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 38419131Fredericks-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.
PubMed 37720040Fredericks-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.
PubMed 35944181
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Return to Effective Dental Infection Control Through Triage and Testing (PREDICT): A PBRN Feasibility Study on COVID-19 Screening in Dental
- ClinicalTrials.gov ID
- NCT05123742
- Acronym / sponsor ID
- PREDICT / Pro2021000968
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), The National Dental Practice-Based Research Network, Kaiser Foundation Research Institute, University of Alabama at Birmingham, University of Rochester, University of Illinois at Chicago
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 17 Nov 2021 (actual)
- Results
- Posted 5 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Data derived from this research would enable dental health care workers to return to work, providing essential oral health care services in the safest possible environment. It will provide patients with confidence that they could resume seeking dental care under optimal conditions that ensure their well-being. The specific aims of this proposal are divided into three parts. The first aim is to apply the Delphi methodology, selecting a facilitator, a panel of experts, defining the problem, addressing the problem with several iterations, and coming to a consensus solution. The second aim is will address the concerns and recommended solutions proposed by the Delphi group and formulated into pragmatic improvements that can be applied to improved practice procedures that can be formulated into testable hypotheses that can be incorporated into a practice strategy for the future of dentistry. Pragmatic and novel methodological changes developed by the investigative team will be presented once again to the Delphi group to gain their approval and/or recommended modifications. Our overarching goal is to test these "improved" strategies in a pilot study and as such the investigators are looking to incorporate two to three methodological suggestions that can be fit into a pragmatic re-design of "best dental practices". Thus, the third aim is designed to test these "best dental practice" approaches in a pilot study. The goal of the third aim is to evaluate how each of these strategies can be applied to different office settings. The data derived from this approach will be used to provide a sample size calculation for a larger study using the PBRN framework for office participation. The all-encompassing aim of the study is to develop a new way of approaching dental practice that ensures a sense of security and practicality for both patients and health professionals. The hypothesis to be tested derived from these aims relates to the structured development of several methodologies that can be applied to dental practice. These methodologic improvements in dental practice will be based on the most current scientific knowledge that can be applied to ensure safety in a dental office setting. To re-iterate the purpose of this study developed from the three aims proposed is to assess and compare each of the pragmatic models developed such that a sample size calculation can be computed. The pilot study design and the sample size calculation derived from this pilot data will compare two to three pragmatic/innovative modifications in the current practice guidelines and provide an estimate that can utilize the larger PBRN framework to best determine the generalizability of the models chosen for study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DHCW Subjects | – | Diagnostic Test: COVID-19 TestingDental Health Care Workers |
| Patient Subjects | – | Diagnostic Test: COVID-19 TestingDental patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female dental health care workers and patients who are seen in a Practice-Based Research Network dentist office.
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 TestingTesting for the SARS-CoV-2 virus | Diagnostic test | DHCW Subjects, Patient Subjects |
Primary outcome
Perception of Safety
Time frame: For DHCW at Day 28 (+/- 14 days), For Patients at their dental visit (day 1)
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.
2 secondary outcomes
Specimen Preference
Time frame: For DHCWs at Day 28 (+/- 13 days); For patients at the time of their dental visit (Day 1)
Testing Protocol Preference
Time frame: For DHCWs at Day 28 (+/- 14 days); For Patients at time of their dental visit (Day 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38419131Fredericks-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.
- Derived from this study: PubMed 37720040Fredericks-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.
- Derived from this study: PubMed 35944181Fredericks-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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecile Feldman, DMD principal investigator
Rutgers School of Dental Medicine
Janine Fredericks-Younger, DMD principal investigator
Rutgers School of Dental Medicine
Modupe Coker, PhD principal investigator
Rutgers School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Infection, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception of Safety (time frame: For DHCW at Day 28 (+/- 14 days), For Patients at their dental visit (day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05123742, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.