Trial Outcomes & Findings for PREDICT: A PBRN Feasibility Study on COVID-19 Screening in Dental Practice (NCT NCT05123742)
NCT ID: NCT05123742
Last Updated: 2023-10-05
Results Overview
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.
COMPLETED
72 participants
For DHCW at Day 28 (+/- 14 days), For Patients at their dental visit (day 1)
2023-10-05
Participant Flow
Participant milestones
| Measure |
DHCW - POC
Dental Health Care Workers undergoing point of care testing
|
DHCW - LAB
Dental Healthcare Workers undergoing laboratory testing
|
Patients - POC
Patients undergoing point of care testing
|
Patients - LAB
Patients undergoing laboratory based testing
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
16
|
20
|
23
|
|
Overall Study
COMPLETED
|
13
|
15
|
19
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PREDICT: A PBRN Feasibility Study on COVID-19 Screening in Dental Practice
Baseline characteristics by cohort
| Measure |
Dental Healthcare Workers - POC
n=13 Participants
Dental Health Care Workers recruited who work in a participating dental office undergoing point-of-care testing
|
Dental Healthcare Workers - LAB
n=16 Participants
Dental Health Care Workers recruited who work in a participating dental office undergoing lab based testing
|
Patient - POC
n=20 Participants
Patients recruited who work in a participating dental office undergoing point-of-care testing
|
Patients-LAB
n=23 Participants
Patients recruited who work in a participating dental office undergoing lab based testing
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: For DHCW at Day 28 (+/- 14 days), For Patients at their dental visit (day 1)Population: Only participants who completed the protocol have been included in the analysis.
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.
Outcome measures
| Measure |
Patients-POC
n=19 Participants
Patients participating in study undergoing point of care testing
|
Dental Healthcare Workers - POC
n=13 Participants
Dental Healthcare Workers participating in study undergoing point of care testing
|
Dental Healthcare Workers - LAB
n=15 Participants
Dental Healthcare Workers undergoing LAB testing
|
Patients - LAB
n=22 Participants
Patients participating in study undergoing laboratory based testing
|
|---|---|---|---|---|
|
Perception of Safety
Perception of safety when only patients are tested
|
60 score on a scale
Interval 29.0 to 98.0
|
74 score on a scale
Interval 50.0 to 85.0
|
51 score on a scale
Interval 48.0 to 76.0
|
52.5 score on a scale
Interval 37.0 to 65.0
|
|
Perception of Safety
Perception of safety when only DHCW are tested
|
95 score on a scale
Interval 80.0 to 100.0
|
82 score on a scale
Interval 73.0 to 90.0
|
60 score on a scale
Interval 50.0 to 83.0
|
71 score on a scale
Interval 62.0 to 76.0
|
|
Perception of Safety
Perception of safety when both patients and DHCW are tested
|
100 score on a scale
Interval 94.0 to 100.0
|
96 score on a scale
Interval 89.0 to 100.0
|
75 score on a scale
Interval 52.0 to 86.0
|
93 score on a scale
Interval 82.0 to 100.0
|
SECONDARY outcome
Timeframe: For DHCWs at Day 28 (+/- 13 days); For patients at the time of their dental visit (Day 1)Population: Analysis population is limited to those participants who completed the protocol
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.
Outcome measures
| Measure |
Patients-POC
n=13 Participants
Patients participating in study undergoing point of care testing
|
Dental Healthcare Workers - POC
n=15 Participants
Dental Healthcare Workers participating in study undergoing point of care testing
|
Dental Healthcare Workers - LAB
n=19 Participants
Dental Healthcare Workers undergoing LAB testing
|
Patients - LAB
n=22 Participants
Patients participating in study undergoing laboratory based testing
|
|---|---|---|---|---|
|
Specimen Preference
Saliva
|
1 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 2.0
|
3 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 2.0
|
|
Specimen Preference
Tongue Epithelial Cells
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 2.0
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 3.0
|
|
Specimen Preference
Nasal Swab
|
2 score on a scale
Interval 1.0 to 3.0
|
3 score on a scale
Interval 2.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 2.0 to 3.0
|
|
Specimen Preference
Nasal-Pharyngeal Swab
|
4 score on a scale
Interval 3.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
6 score on a scale
Interval 2.0 to 6.0
|
4 score on a scale
Interval 4.0 to 4.0
|
|
Specimen Preference
Finger Stick (Capillary Blood)
|
5 score on a scale
Interval 5.0 to 5.0
|
5 score on a scale
Interval 5.0 to 5.0
|
5 score on a scale
Interval 3.0 to 6.0
|
5 score on a scale
Interval 5.0 to 5.0
|
|
Specimen Preference
Venous Blood
|
6 score on a scale
Interval 6.0 to 6.0
|
6 score on a scale
Interval 6.0 to 6.0
|
6 score on a scale
Interval 5.0 to 6.0
|
6 score on a scale
Interval 6.0 to 6.0
|
SECONDARY outcome
Timeframe: For DHCWs at Day 28 (+/- 14 days); For Patients at time of their dental visit (Day 1)Population: Only participants who completed the protocol are included in this analysis.
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.
Outcome measures
| Measure |
Patients-POC
n=13 Participants
Patients participating in study undergoing point of care testing
|
Dental Healthcare Workers - POC
n=15 Participants
Dental Healthcare Workers participating in study undergoing point of care testing
|
Dental Healthcare Workers - LAB
n=19 Participants
Dental Healthcare Workers undergoing LAB testing
|
Patients - LAB
n=22 Participants
Patients participating in study undergoing laboratory based testing
|
|---|---|---|---|---|
|
Testing Protocol Preference
Specimen collected at home and mailed to the lab for processing
|
2 score on a scale
Interval 2.0 to 4.0
|
1 score on a scale
Interval 1.0 to 2.0
|
2 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Testing Protocol Preference
Point-of-care test in the dental office
|
1 score on a scale
Interval 1.0 to 2.0
|
3 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 3.0
|
2.5 score on a scale
Interval 1.0 to 3.0
|
|
Testing Protocol Preference
Specimen collected in the dnetal office and mail to the lab for processing
|
3 score on a scale
Interval 2.0 to 3.0
|
2 score on a scale
Interval 2.0 to 2.0
|
3 score on a scale
Interval 3.0 to 3.0
|
2 score on a scale
Interval 2.0 to 3.0
|
|
Testing Protocol Preference
Specimen collected at a commercial lab and processed at the lab
|
4 score on a scale
Interval 3.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
4 score on a scale
Interval 3.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
Adverse Events
DHCW - POC
DHCW - LAB
Patients - POC
Patients - LAB
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Cecile A. Feldman, DMD, MBA
Rutgers School of Dental Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place