Trial Outcomes & Findings for Decision Aids for the Management of Suspicious Occlusal Caries Lesions (NCT NCT02340767)
NCT ID: NCT02340767
Last Updated: 2019-04-03
Results Overview
There was one lesion/patient.
COMPLETED
NA
3085 participants
Pre-intervention and post-intervention (one day visit)
2019-04-03
Participant Flow
The study had a pre-intervention phase, 108 clinicians (HS trained, consented, and met eligibility criterion) and 1500 patients enrolled. 85 clinicians met the enrollment threshold and were randomized.1500 patients were in the post-intervention phase.The pre- and post patients were not the same so the number analyzed for each group varies.
Participant milestones
| Measure |
No Device Practitioners
The practitioners will not receive any additional training.
|
Spectra Device Practitioners
The practitioners in the Spectra Device Arm will be trained to the device according to the manufacturers' usual care for training. The training will consist of viewing the manufacturer's instructions for the device. Training will also consist of practitioners familiarizing themselves with the device through unsupervised clinical use with patients.
Spectra Device: Spectra Caries detection device is used for study data collection recording the results of the dental examination and recording results of dental treatment.
|
DIAGNOdent Device Practitioners
The practitioners in the DIAGNOdent Device Arm will be trained to the device according to the manufacturers' usual care for training. The training will consist of viewing the manufacturer's instructions for the device. Training will also consist of practitioners familiarizing themselves with the device through unsupervised clinical use with patients.
DIAGNOdent: DIAGNOdent Caries detection device is used for study data collection recording the results of the dental examination and recording results of dental treatment.
|
Pre-intervention Patients no Device
The patients in the pre-intervention group were not the same as the one in the post-intervention group. The clinicians were the same.
|
Pre-randomization Patients Spectra
The patients in the pre-intervention group were not the same as the one in the post-intervention group. The clinicians were the same.
|
Pre-randomization Patients DIANGOdent
The patients in the pre-intervention group were not the same as the one in the post-intervention group. The clinicians were the same.
|
Post-randomization Patients no Device
The patients in the pre-intervention group were not the same as the one in the post-intervention group. The clinicians were the same.
|
Post-randomization Patients Spectra
The patients in the pre-intervention group were not the same as the one in the post-intervention group. The clinicians were the same.
|
Post-randomization Patients DIAGNOdent
The patients in the pre-intervention group were not the same as the one in the post-intervention group. The clinicians were the same.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
29
|
500
|
474
|
526
|
525
|
444
|
531
|
|
Overall Study
COMPLETED
|
28
|
28
|
29
|
500
|
474
|
526
|
525
|
444
|
531
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The pre-intervention patients were different than the post-intervention patients. Clinicians were the same.
Baseline characteristics by cohort
| Measure |
No Device Patients Pre-intervention
n=500 Participants
All pre-and post-intervention patients were different, which is why the numbers don't match. We place the pre-intervention patients into the arm their clinican was ultimately assigned to.
|
Spectra Device Patients Pre-intervention
n=474 Participants
All pre-and post-intervention patients were different, which is why the numbers don't match. We place the pre-intervention patients into the arm their clinican was ultimately assigned to.
|
DIAGNOdent Device Patients Pre-intervention
n=526 Participants
All pre-and post-intervention patients were different, which is why the numbers don't match. We place the pre-intervention patients into the arm their clinican was ultimately assigned to.
|
No Device Clinicians
n=28 Participants
They received no device at randomization
|
Spectra Clinicians
n=28 Participants
The practitioners in the Spectra Device Arm will be trained to the device according to the manufacturers' usual care for training. The training will consist of viewing the manufacturer's instructions for the device. Training will also consist of practitioners familiarizing themselves with the device through unsupervised clinical use with patients.
|
DIAGNOdent Clinicians
n=29 Participants
The practitioners in the DIAGNOdent Device Arm will be trained to the device according to the manufacturers' usual care for training. The training will consist of viewing the manufacturer's instructions for the device. Training will also consist of practitioners familiarizing themselves with the device through unsupervised clinical use with patients.
|
No Device Patients Post-intervention
n=525 Participants
|
Spectra Device Patients Post-intervention
n=444 Participants
|
DIAGNOdent Device Patients Post-intervention
n=531 Participants
|
Total
n=3085 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
All patients and clinicians
|
32.3 years
STANDARD_DEVIATION 17.5 • n=5 Participants
|
30.1 years
STANDARD_DEVIATION 17.0 • n=7 Participants
|
34.7 years
STANDARD_DEVIATION 17.3 • n=5 Participants
|
NA years
STANDARD_DEVIATION NA • n=4 Participants
|
NA years
STANDARD_DEVIATION NA • n=21 Participants
|
NA years
STANDARD_DEVIATION NA • n=8 Participants
|
37.2 years
STANDARD_DEVIATION 19.2 • n=8 Participants
|
36.3 years
STANDARD_DEVIATION 16.1 • n=24 Participants
|
34.7 years
STANDARD_DEVIATION 16.8 • n=42 Participants
|
36.0 years
STANDARD_DEVIATION 17.4 • n=42 Participants
|
|
Sex: Female, Male
All patients and clinicians · Female
|
303 Participants
n=5 Participants • The pre-intervention patients were different than the post-intervention patients. Clinicians were the same.
|
252 Participants
n=7 Participants • The pre-intervention patients were different than the post-intervention patients. Clinicians were the same.
|
328 Participants
n=5 Participants • The pre-intervention patients were different than the post-intervention patients. Clinicians were the same.
|
11 Participants
n=4 Participants • The pre-intervention patients were different than the post-intervention patients. Clinicians were the same.
|
10 Participants
n=21 Participants • The pre-intervention patients were different than the post-intervention patients. Clinicians were the same.
|
12 Participants
n=8 Participants • The pre-intervention patients were different than the post-intervention patients. Clinicians were the same.
|
297 Participants
n=8 Participants • The pre-intervention patients were different than the post-intervention patients. Clinicians were the same.
|
269 Participants
n=24 Participants • The pre-intervention patients were different than the post-intervention patients. Clinicians were the same.
|
302 Participants
n=42 Participants • The pre-intervention patients were different than the post-intervention patients. Clinicians were the same.
|
1784 Participants
n=42 Participants • The pre-intervention patients were different than the post-intervention patients. Clinicians were the same.
|
|
Sex: Female, Male
All patients and clinicians · Male
|
197 Participants
n=5 Participants • The pre-intervention patients were different than the post-intervention patients. Clinicians were the same.
|
222 Participants
n=7 Participants • The pre-intervention patients were different than the post-intervention patients. Clinicians were the same.
|
198 Participants
n=5 Participants • The pre-intervention patients were different than the post-intervention patients. Clinicians were the same.
|
17 Participants
n=4 Participants • The pre-intervention patients were different than the post-intervention patients. Clinicians were the same.
|
18 Participants
n=21 Participants • The pre-intervention patients were different than the post-intervention patients. Clinicians were the same.
|
17 Participants
n=8 Participants • The pre-intervention patients were different than the post-intervention patients. Clinicians were the same.
|
228 Participants
n=8 Participants • The pre-intervention patients were different than the post-intervention patients. Clinicians were the same.
|
175 Participants
n=24 Participants • The pre-intervention patients were different than the post-intervention patients. Clinicians were the same.
|
229 Participants
n=42 Participants • The pre-intervention patients were different than the post-intervention patients. Clinicians were the same.
|
1301 Participants
n=42 Participants • The pre-intervention patients were different than the post-intervention patients. Clinicians were the same.
|
|
Ethnicity (NIH/OMB)
Patients and Clinicians · Hispanic or Latino
|
77 Participants
n=5 Participants • Patients at the pre-intervention stage are not the same patients as post-randomization, which is why the numbers are different in both phases. Clinicians were the same.
|
73 Participants
n=7 Participants • Patients at the pre-intervention stage are not the same patients as post-randomization, which is why the numbers are different in both phases. Clinicians were the same.
|
84 Participants
n=5 Participants • Patients at the pre-intervention stage are not the same patients as post-randomization, which is why the numbers are different in both phases. Clinicians were the same.
|
0 Participants
n=4 Participants • Patients at the pre-intervention stage are not the same patients as post-randomization, which is why the numbers are different in both phases. Clinicians were the same.
|
0 Participants
n=21 Participants • Patients at the pre-intervention stage are not the same patients as post-randomization, which is why the numbers are different in both phases. Clinicians were the same.
|
1 Participants
n=8 Participants • Patients at the pre-intervention stage are not the same patients as post-randomization, which is why the numbers are different in both phases. Clinicians were the same.
|
60 Participants
n=8 Participants • Patients at the pre-intervention stage are not the same patients as post-randomization, which is why the numbers are different in both phases. Clinicians were the same.
|
20 Participants
n=24 Participants • Patients at the pre-intervention stage are not the same patients as post-randomization, which is why the numbers are different in both phases. Clinicians were the same.
|
51 Participants
n=42 Participants • Patients at the pre-intervention stage are not the same patients as post-randomization, which is why the numbers are different in both phases. Clinicians were the same.
|
366 Participants
n=42 Participants • Patients at the pre-intervention stage are not the same patients as post-randomization, which is why the numbers are different in both phases. Clinicians were the same.
|
|
Ethnicity (NIH/OMB)
Patients and Clinicians · Not Hispanic or Latino
|
395 Participants
n=5 Participants • Patients at the pre-intervention stage are not the same patients as post-randomization, which is why the numbers are different in both phases. Clinicians were the same.
|
391 Participants
n=7 Participants • Patients at the pre-intervention stage are not the same patients as post-randomization, which is why the numbers are different in both phases. Clinicians were the same.
|
417 Participants
n=5 Participants • Patients at the pre-intervention stage are not the same patients as post-randomization, which is why the numbers are different in both phases. Clinicians were the same.
|
26 Participants
n=4 Participants • Patients at the pre-intervention stage are not the same patients as post-randomization, which is why the numbers are different in both phases. Clinicians were the same.
|
26 Participants
n=21 Participants • Patients at the pre-intervention stage are not the same patients as post-randomization, which is why the numbers are different in both phases. Clinicians were the same.
|
28 Participants
n=8 Participants • Patients at the pre-intervention stage are not the same patients as post-randomization, which is why the numbers are different in both phases. Clinicians were the same.
|
443 Participants
n=8 Participants • Patients at the pre-intervention stage are not the same patients as post-randomization, which is why the numbers are different in both phases. Clinicians were the same.
|
400 Participants
n=24 Participants • Patients at the pre-intervention stage are not the same patients as post-randomization, which is why the numbers are different in both phases. Clinicians were the same.
|
450 Participants
n=42 Participants • Patients at the pre-intervention stage are not the same patients as post-randomization, which is why the numbers are different in both phases. Clinicians were the same.
|
2576 Participants
n=42 Participants • Patients at the pre-intervention stage are not the same patients as post-randomization, which is why the numbers are different in both phases. Clinicians were the same.
|
|
Ethnicity (NIH/OMB)
Patients and Clinicians · Unknown or Not Reported
|
28 Participants
n=5 Participants • Patients at the pre-intervention stage are not the same patients as post-randomization, which is why the numbers are different in both phases. Clinicians were the same.
|
10 Participants
n=7 Participants • Patients at the pre-intervention stage are not the same patients as post-randomization, which is why the numbers are different in both phases. Clinicians were the same.
|
25 Participants
n=5 Participants • Patients at the pre-intervention stage are not the same patients as post-randomization, which is why the numbers are different in both phases. Clinicians were the same.
|
2 Participants
n=4 Participants • Patients at the pre-intervention stage are not the same patients as post-randomization, which is why the numbers are different in both phases. Clinicians were the same.
|
2 Participants
n=21 Participants • Patients at the pre-intervention stage are not the same patients as post-randomization, which is why the numbers are different in both phases. Clinicians were the same.
|
0 Participants
n=8 Participants • Patients at the pre-intervention stage are not the same patients as post-randomization, which is why the numbers are different in both phases. Clinicians were the same.
|
22 Participants
n=8 Participants • Patients at the pre-intervention stage are not the same patients as post-randomization, which is why the numbers are different in both phases. Clinicians were the same.
|
24 Participants
n=24 Participants • Patients at the pre-intervention stage are not the same patients as post-randomization, which is why the numbers are different in both phases. Clinicians were the same.
|
30 Participants
n=42 Participants • Patients at the pre-intervention stage are not the same patients as post-randomization, which is why the numbers are different in both phases. Clinicians were the same.
|
143 Participants
n=42 Participants • Patients at the pre-intervention stage are not the same patients as post-randomization, which is why the numbers are different in both phases. Clinicians were the same.
|
|
Race (NIH/OMB)
Patients and Clinicians · American Indian or Alaska Native
|
6 Participants
n=5 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
4 Participants
n=7 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
9 Participants
n=5 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
1 Participants
n=4 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
0 Participants
n=21 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
0 Participants
n=8 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
14 Participants
n=8 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
15 Participants
n=24 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
17 Participants
n=42 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
66 Participants
n=42 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
|
Race (NIH/OMB)
Patients and Clinicians · Asian
|
16 Participants
n=5 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
21 Participants
n=7 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
21 Participants
n=5 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
3 Participants
n=4 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
4 Participants
n=21 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
6 Participants
n=8 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
7 Participants
n=8 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
1 Participants
n=24 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
2 Participants
n=42 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
81 Participants
n=42 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
|
Race (NIH/OMB)
Patients and Clinicians · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
4 Participants
n=7 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
2 Participants
n=5 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
NA Participants
n=4 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
NA Participants
n=21 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
NA Participants
n=8 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
4 Participants
n=8 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
2 Participants
n=24 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
1 Participants
n=42 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
NA Participants
n=42 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
|
Race (NIH/OMB)
Patients and Clinicians · Black or African American
|
85 Participants
n=5 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
72 Participants
n=7 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
76 Participants
n=5 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
2 Participants
n=4 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
1 Participants
n=21 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
3 Participants
n=8 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
55 Participants
n=8 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
66 Participants
n=24 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
85 Participants
n=42 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
445 Participants
n=42 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
|
Race (NIH/OMB)
Patients and Clinicians · White
|
353 Participants
n=5 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
322 Participants
n=7 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
378 Participants
n=5 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
21 Participants
n=4 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
20 Participants
n=21 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
18 Participants
n=8 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
407 Participants
n=8 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
348 Participants
n=24 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
388 Participants
n=42 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
2255 Participants
n=42 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
|
Race (NIH/OMB)
Patients and Clinicians · More than one race
|
11 Participants
n=5 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
11 Participants
n=7 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
6 Participants
n=5 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
NA Participants
n=4 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
NA Participants
n=21 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
NA Participants
n=8 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
9 Participants
n=8 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
4 Participants
n=24 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
7 Participants
n=42 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
NA Participants
n=42 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
|
Race (NIH/OMB)
Patients and Clinicians · Unknown or Not Reported
|
29 Participants
n=5 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
40 Participants
n=7 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
34 Participants
n=5 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
1 Participants
n=4 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
3 Participants
n=21 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
2 Participants
n=8 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
29 Participants
n=8 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
8 Participants
n=24 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
31 Participants
n=42 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
177 Participants
n=42 Participants • The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.
|
|
Region of Enrollment
United States
|
500 patients and clinicians
n=5 Participants
|
474 patients and clinicians
n=7 Participants
|
526 patients and clinicians
n=5 Participants
|
28 patients and clinicians
n=4 Participants
|
28 patients and clinicians
n=21 Participants
|
29 patients and clinicians
n=8 Participants
|
525 patients and clinicians
n=8 Participants
|
444 patients and clinicians
n=24 Participants
|
531 patients and clinicians
n=42 Participants
|
3085 patients and clinicians
n=42 Participants
|
|
Number of Patients and Clinicians
|
500 Participants
n=5 Participants
|
474 Participants
n=7 Participants
|
526 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
29 Participants
n=8 Participants
|
525 Participants
n=8 Participants
|
444 Participants
n=24 Participants
|
531 Participants
n=42 Participants
|
3085 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Pre-intervention and post-intervention (one day visit)Population: Only the patients who received invasive treatment were analyzed for extension into dentin.Not all columns add up to the total N due to missing values.
There was one lesion/patient.
Outcome measures
| Measure |
No Device Patients in Pre-intervention
n=1500 Participants
The patients in pre-intervention are different than post-intervention.
|
No Device Patients Post-intervention
n=525 Participants
The patients in the pre-intervention stage are not the same as the post-intervention stage.
|
Spectra Patients Post-intervention
n=444 Participants
The patients in the pre-intervention stage are not the same as the post-intervention stage
|
DIAGNOdent Patients Post-intervention
n=531 Participants
The patients in the pre-intervention stage are not the same as the post-intervention stage
|
|---|---|---|---|---|
|
Number of Lesions That Received Invasive Treatment and the Number of Lesions Receiving Invasive Treatment That Extended Into Dentin
Extended into dentin : No
|
217 lesions
|
76 lesions
|
74 lesions
|
77 lesions
|
|
Number of Lesions That Received Invasive Treatment and the Number of Lesions Receiving Invasive Treatment That Extended Into Dentin
Invasive (yes/no) : Yes
|
603 lesions
|
246 lesions
|
213 lesions
|
248 lesions
|
|
Number of Lesions That Received Invasive Treatment and the Number of Lesions Receiving Invasive Treatment That Extended Into Dentin
Invasive (yes/no) : No
|
885 lesions
|
277 lesions
|
226 lesions
|
276 lesions
|
|
Number of Lesions That Received Invasive Treatment and the Number of Lesions Receiving Invasive Treatment That Extended Into Dentin
Extended into dentin : Yes
|
349 lesions
|
151 lesions
|
133 lesions
|
144 lesions
|
SECONDARY outcome
Timeframe: Post-intervention (dentists completed the vignettes one time)Clinicians' likelihood of treating surgical lesions depicted with brown verses black, smooth verses rough, shiny verses matte, in patients with high verses low caries risk, by post-intervention phases. The outcome measure will be to see what cues were used or treatment decisions in the post-intervention phase. Please note that more than one cue could be chosen, so values may add up to more than 100 percent. Participants in the no device group did not receive a device reading cue.
Outcome measures
| Measure |
No Device Patients in Pre-intervention
n=28 Participants
The patients in pre-intervention are different than post-intervention.
|
No Device Patients Post-intervention
n=28 Participants
The patients in the pre-intervention stage are not the same as the post-intervention stage.
|
Spectra Patients Post-intervention
n=29 Participants
The patients in the pre-intervention stage are not the same as the post-intervention stage
|
DIAGNOdent Patients Post-intervention
The patients in the pre-intervention stage are not the same as the post-intervention stage
|
|---|---|---|---|---|
|
Number of Clinicians in Likelihood of Surgically Treating Lesions in Online Vignettes That Display Two Levels of Five Cues (Color, Surface Smoothness, Surface Luster, Caries Risk, and Device Reading (if Applicable) in Post-intervention
Luster
|
15 Participants
|
14 Participants
|
12 Participants
|
—
|
|
Number of Clinicians in Likelihood of Surgically Treating Lesions in Online Vignettes That Display Two Levels of Five Cues (Color, Surface Smoothness, Surface Luster, Caries Risk, and Device Reading (if Applicable) in Post-intervention
Device reading
|
0 Participants
|
23 Participants
|
27 Participants
|
—
|
|
Number of Clinicians in Likelihood of Surgically Treating Lesions in Online Vignettes That Display Two Levels of Five Cues (Color, Surface Smoothness, Surface Luster, Caries Risk, and Device Reading (if Applicable) in Post-intervention
Color
|
15 Participants
|
12 Participants
|
11 Participants
|
—
|
|
Number of Clinicians in Likelihood of Surgically Treating Lesions in Online Vignettes That Display Two Levels of Five Cues (Color, Surface Smoothness, Surface Luster, Caries Risk, and Device Reading (if Applicable) in Post-intervention
Risk
|
13 Participants
|
10 Participants
|
18 Participants
|
—
|
|
Number of Clinicians in Likelihood of Surgically Treating Lesions in Online Vignettes That Display Two Levels of Five Cues (Color, Surface Smoothness, Surface Luster, Caries Risk, and Device Reading (if Applicable) in Post-intervention
Feel of the lesion
|
11 Participants
|
10 Participants
|
10 Participants
|
—
|
SECONDARY outcome
Timeframe: Pre-intervention (dentists completed the vignettes one time)Population: Pre-intervention the dentists were not randomized and had no device training and all dentists were combined
Clinicians' likelihood of treating surgical lesions depicted with brown verses black, smooth verses rough, shiny verses matte, in patients with high verses low caries risk, by post-intervention phases. The outcome measure will be to see what cues were used or treatment decisions in the pre-intervention phase. Please note that more than one cue could be chosen, so values may add to more than 100 percent of participants.
Outcome measures
| Measure |
No Device Patients in Pre-intervention
n=85 Participants
The patients in pre-intervention are different than post-intervention.
|
No Device Patients Post-intervention
The patients in the pre-intervention stage are not the same as the post-intervention stage.
|
Spectra Patients Post-intervention
The patients in the pre-intervention stage are not the same as the post-intervention stage
|
DIAGNOdent Patients Post-intervention
The patients in the pre-intervention stage are not the same as the post-intervention stage
|
|---|---|---|---|---|
|
Number of Clinicians in Likelihood of Surgically Treating Lesions in Online Vignettes That Display Two Levels of Four Cues (Color, Surface Smoothness, Surface Luster, and Caries Risk) in Pre-intervention
Feel of the lesion
|
31 Participants
|
—
|
—
|
—
|
|
Number of Clinicians in Likelihood of Surgically Treating Lesions in Online Vignettes That Display Two Levels of Four Cues (Color, Surface Smoothness, Surface Luster, and Caries Risk) in Pre-intervention
Luster
|
49 Participants
|
—
|
—
|
—
|
|
Number of Clinicians in Likelihood of Surgically Treating Lesions in Online Vignettes That Display Two Levels of Four Cues (Color, Surface Smoothness, Surface Luster, and Caries Risk) in Pre-intervention
Color
|
40 Participants
|
—
|
—
|
—
|
|
Number of Clinicians in Likelihood of Surgically Treating Lesions in Online Vignettes That Display Two Levels of Four Cues (Color, Surface Smoothness, Surface Luster, and Caries Risk) in Pre-intervention
Risk
|
29 Participants
|
—
|
—
|
—
|
Adverse Events
No Device Clinicians
Spectra Device Clinicians
DIAGNOdent Device Clinicians
No Device Patients (Pre-intervention and Post-intervention)
Spectra Patients (Pre-intervention and Post-intervention)
DIAGNOdent Patients (Pre-intervention and Post-intervention)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place