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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

3085 participants

Primary outcome timeframe

Pre-intervention and post-intervention (one day visit)

Results posted on

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

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

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

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

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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Spectra Device Clinicians

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

DIAGNOdent Device Clinicians

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

No Device Patients (Pre-intervention and Post-intervention)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Spectra Patients (Pre-intervention and Post-intervention)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

DIAGNOdent Patients (Pre-intervention and Post-intervention)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sonia Makhija

National Dental PBRN

Phone: 2059965298

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place