SOCL: Decision Aids for the Management of Suspicious Occlusal Caries Lesions
Study Details
Study Description
Brief Summary
The study will determine whether clinicians who use a diagnostic device treat suspicious occlusal carious lesions (SOCL) surgically more often, with the same frequency, or less frequently, than dentists not relying on a diagnostic device. The study will also determine -- among those SOCLs that are opened -- whether the proportion of lesions that extend into the dentin when dentists are using a diagnostic device is more than, the same, or less than when no device is used.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The overall objectives of this study is to assess the contributions of diagnostic devices in clinicians' decision-making processes surrounding suspicious occlusal carious lesions (SOCL), an assessment that has not yet been attempted, despite the growing popularity of these devices. SOCLs can be defined as occlusal surface areas where visual, tactile, and radiographic signs are insufficient to definitively diagnose caries but where some of these signs are present.This study examines the use of two diagnostic devices on dental practitioners' identification and treatment of SOCLs.
During a four-week pre-intervention period, 90 clinicians will collect and record descriptive and treatment information for the SOCLs they identify. Clinicians will then be randomized into one of 3 study arms: no diagnostic device, DIAGNOdent®, and Spectra®, and will collect and record similar information as the pre-intervention period for another six weeks, enrolling an additional 20 SOCLs. They will also complete diagnostic vignettes at the beginning and end of the study, as well as a post-study questionnaire on the utility of the devices, if assigned to a device arm. Analyses will examine differences in proportion of SOCLs treated surgically in the groups with and without the diagnostic device; and, for those treated surgically, differences in the proportions of SOCLs with extension into dentin. Differences in pre- and post-study responses on the vignettes will suggest which components of the decision-making process involved in SOCL identification and management have been modified by use of the diagnostic devices.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: No Device Clinicians The clinicians will not receive any additional training. |
|
| Experimental: Spectra Device Clinicians The clinicians 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 clinicians familiarizing themselves with the device through unsupervised clinical use with patients. |
Device: 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.
|
| Experimental: DIAGNOdent Device Practitioners The clinicians 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 clinicians familiarizing themselves with the device through unsupervised clinical use with patients. |
Device: DIAGNOdent
DIAGNOdent Caries detection device is used for study data collection recording the results of the dental examination and recording results of dental treatment.
|
Outcome Measures
Primary Outcome Measures
- Number of Lesions That Received Invasive Treatment and the Number of Lesions Receiving Invasive Treatment That Extended Into Dentin [Pre-intervention and post-intervention (one day visit)]
There was one lesion/patient.
Secondary Outcome Measures
- 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 [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.
- 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 [Pre-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 pre-intervention phase. Please note that more than one cue could be chosen, so values may add to more than 100 percent of participants.
Eligibility Criteria
Criteria
Inclusion Criteria:
Practitioner: In order to be eligible to participate in this study, an individual must meet all of the following criteria:
-
Is enrolled in the National Dental Practice Based Research Network (National Dental PBRN);
-
Has completed an Enrollment Questionnaire;
-
Is a general or pediatric dentist who is licensed in the United States to treat patients and treats patients in the United States on a recurring basis;
-
Is trained and certified in Human Subjects Protection Training;
-
Has attended or viewed a National Dental PBRN orientation session or attended at least one annual regional meeting of practitioners or has attended a National Dental PBRN workshop at the International Association for Dental Research (IADR) or American Association for Dental Research (AADR).
-
Performs restorative dentistry routinely in their practices as reported on the enrollment questionnaire;
-
Has no clinical experience (no history of routine use in practice within the past one year) with either of the devices being used in the study and declares no conflict of interest with the corporations that produce DIAGNOdent® and Spectra®; and
-
Is able to complete the pre-and post-study vignettes online.
Practice: If a practitioner is in a practice where they share an operatory (including a hygiene chair) only 1 dentist can be recruited from that practice.
Patient: In order to be eligible to participate in this study, an individual with a SOCL must meet all of the following criteria:
-
Willing to provide consent according to regionally approved procedures and/or obtain parent/legal guardian permission as applicable;
-
Willing to comply with all study procedures; Is six years of age or older; and
-
Has not participated in the study previously. Patients will be enrolled only once throughout the study (this includes the pre-intervention and intervention phases for the pilot study and full study).
Tooth: In order to be eligible to be included in this study, a tooth with a SOCL must meet all of the following criteria:
-
Permanent tooth;
-
No radiographic evidence of caries into dentin based on available radiographs;
-
Caries into dentin is suspected due to roughness, surface opacities, or staining;
-
No symptoms of sensitivity to sweets, cold, air, etc.;
-
No restoration on the occlusal surface; and
-
No sealant on occlusal surface.
Exclusion Criteria:
-
Under the age of 6 years old
-
Primary Teeth
-
Evidence of Caries into dentin based on available radiographs
-
Sensitivity to sweets, cold, air etc.;
-
Restoration on the occlusal surface
-
Sealant on occlusal surface
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35294 |
| 2 | University of Florida | Gainesville | Florida | United States | 32610 |
| 3 | HealthPartners Institute for Education and Research | Minneapolis | Minnesota | United States | 55445 |
| 4 | University of Rochester | Rochester | New York | United States | 14620 |
| 5 | Kaiser Permanente Center for Health Research | Portland | Oregon | United States | 97227-1110 |
| 6 | University of Texas Health Science Center at San Antonio | San Antonio | Texas | United States | 78229 |
Sponsors and Collaborators
- The National Dental Practice-Based Research Network
- Kaiser Permanente
- HealthPartners Institute
- The University of Texas Health Science Center at San Antonio
- University of Alabama at Birmingham
- University of Florida
- University of Rochester
Investigators
- Study Director: Gregg H Gilbert, DDS, MBA, University of Alabama at Birmingham
- Principal Investigator: Sonia K Makhija, DDS, MPH, University of Alabama at Birmingham
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 14-003-E
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | No Device Practitioners | Spectra Device Practitioners | DIAGNOdent Device Practitioners | Pre-intervention Patients no Device | Pre-randomization Patients Spectra | Pre-randomization Patients DIANGOdent | Post-randomization Patients no Device | Post-randomization Patients Spectra | Post-randomization Patients DIAGNOdent |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | The practitioners will not receive any additional training. | 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. | 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. | The patients in the pre-intervention group were not the same as the one in the post-intervention group. The clinicians were the same. | The patients in the pre-intervention group were not the same as the one in the post-intervention group. The clinicians were the same. | The patients in the pre-intervention group were not the same as the one in the post-intervention group. The clinicians were the same. | The patients in the pre-intervention group were not the same as the one in the post-intervention group. The clinicians were the same. | The patients in the pre-intervention group were not the same as the one in the post-intervention group. The clinicians were the same. | The patients in the pre-intervention group were not the same as the one in the post-intervention group. The clinicians were the same. |
| Period Title: Overall Study | |||||||||
| STARTED | 28 | 28 | 29 | 500 | 474 | 526 | 525 | 444 | 531 |
| COMPLETED | 28 | 28 | 29 | 500 | 474 | 526 | 525 | 444 | 531 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | No Device Patients Pre-intervention | Spectra Device Patients Pre-intervention | DIAGNOdent Device Patients Pre-intervention | No Device Clinicians | Spectra Clinicians | DIAGNOdent Clinicians | No Device Patients Post-intervention | Spectra Device Patients Post-intervention | DIAGNOdent Device Patients Post-intervention | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | They received no device at randomization | 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. | 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. | Total of all reporting groups | |||
| Overall Participants | 500 | 474 | 526 | 28 | 28 | 29 | 525 | 444 | 531 | 3085 |
| Age (years) [Mean (Standard Deviation) ] | ||||||||||
| All patients and clinicians |
32.3
(17.5)
|
30.1
(17.0)
|
34.7
(17.3)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
37.2
(19.2)
|
36.3
(16.1)
|
34.7
(16.8)
|
36.0
(17.4)
|
| Sex: Female, Male (Count of Participants) | ||||||||||
| Female |
303
60.6%
|
252
53.2%
|
328
62.4%
|
11
39.3%
|
10
35.7%
|
12
41.4%
|
297
56.6%
|
269
60.6%
|
302
56.9%
|
1784
57.8%
|
| Male |
197
39.4%
|
222
46.8%
|
198
37.6%
|
17
60.7%
|
18
64.3%
|
17
58.6%
|
228
43.4%
|
175
39.4%
|
229
43.1%
|
1301
42.2%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||||||||
| Hispanic or Latino |
77
15.4%
|
73
15.4%
|
84
16%
|
0
0%
|
0
0%
|
1
3.4%
|
60
11.4%
|
20
4.5%
|
51
9.6%
|
366
11.9%
|
| Not Hispanic or Latino |
395
79%
|
391
82.5%
|
417
79.3%
|
26
92.9%
|
26
92.9%
|
28
96.6%
|
443
84.4%
|
400
90.1%
|
450
84.7%
|
2576
83.5%
|
| Unknown or Not Reported |
28
5.6%
|
10
2.1%
|
25
4.8%
|
2
7.1%
|
2
7.1%
|
0
0%
|
22
4.2%
|
24
5.4%
|
30
5.6%
|
143
4.6%
|
| Race (NIH/OMB) (Count of Participants) | ||||||||||
| American Indian or Alaska Native |
6
1.2%
|
4
0.8%
|
9
1.7%
|
1
3.6%
|
0
0%
|
0
0%
|
14
2.7%
|
15
3.4%
|
17
3.2%
|
66
2.1%
|
| Asian |
16
3.2%
|
21
4.4%
|
21
4%
|
3
10.7%
|
4
14.3%
|
6
20.7%
|
7
1.3%
|
1
0.2%
|
2
0.4%
|
81
2.6%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
4
0.8%
|
2
0.4%
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
4
0.8%
|
2
0.5%
|
1
0.2%
|
NA
NaN
|
| Black or African American |
85
17%
|
72
15.2%
|
76
14.4%
|
2
7.1%
|
1
3.6%
|
3
10.3%
|
55
10.5%
|
66
14.9%
|
85
16%
|
445
14.4%
|
| White |
353
70.6%
|
322
67.9%
|
378
71.9%
|
21
75%
|
20
71.4%
|
18
62.1%
|
407
77.5%
|
348
78.4%
|
388
73.1%
|
2255
73.1%
|
| More than one race |
11
2.2%
|
11
2.3%
|
6
1.1%
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
9
1.7%
|
4
0.9%
|
7
1.3%
|
NA
NaN
|
| Unknown or Not Reported |
29
5.8%
|
40
8.4%
|
34
6.5%
|
1
3.6%
|
3
10.7%
|
2
6.9%
|
29
5.5%
|
8
1.8%
|
31
5.8%
|
177
5.7%
|
| Region of Enrollment (patients and clinicians) [Number] | ||||||||||
| United States |
500
|
474
|
526
|
28
|
28
|
29
|
525
|
444
|
531
|
3085
|
| Number of Patients and Clinicians (Count of Participants) | ||||||||||
| Count of Participants [Participants] |
500
100%
|
474
100%
|
526
100%
|
28
100%
|
28
100%
|
29
100%
|
525
100%
|
444
100%
|
531
100%
|
3085
100%
|
Outcome Measures
| Title | Number of Lesions That Received Invasive Treatment and the Number of Lesions Receiving Invasive Treatment That Extended Into Dentin |
|---|---|
| Description | There was one lesion/patient. |
| Time Frame | Pre-intervention and post-intervention (one day visit) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | No Device Patients in Pre-intervention | No Device Patients Post-intervention | Spectra Patients Post-intervention | DIAGNOdent Patients Post-intervention |
|---|---|---|---|---|
| Arm/Group Description | The patients in pre-intervention are different than post-intervention. | The patients in the pre-intervention stage are not the same as the post-intervention stage. | The patients in the pre-intervention stage are not the same as the post-intervention stage | The patients in the pre-intervention stage are not the same as the post-intervention stage |
| Measure Participants | 1500 | 525 | 444 | 531 |
| Invasive (yes/no) : Yes |
603
|
246
|
213
|
248
|
| Invasive (yes/no) : No |
885
|
277
|
226
|
276
|
| Extended into dentin : Yes |
349
|
151
|
133
|
144
|
| Extended into dentin : No |
217
|
76
|
74
|
77
|
| Title | 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 |
|---|---|
| Description | 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. |
| Time Frame | Post-intervention (dentists completed the vignettes one time) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | No Device Practitioners | Spectra Device Practitioners | DIAGNOdent Device Practitioners |
|---|---|---|---|
| Arm/Group Description | The practitioners will not receive any additional training. | 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. | 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. |
| Measure Participants | 28 | 28 | 29 |
| Luster |
15
3%
|
14
3%
|
12
2.3%
|
| Color |
15
3%
|
12
2.5%
|
11
2.1%
|
| Risk |
13
2.6%
|
10
2.1%
|
18
3.4%
|
| Feel of the lesion |
11
2.2%
|
10
2.1%
|
10
1.9%
|
| Device reading |
0
0%
|
23
4.9%
|
27
5.1%
|
| Title | 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 |
|---|---|
| Description | 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. |
| Time Frame | Pre-intervention (dentists completed the vignettes one time) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pre-intervention the dentists were not randomized and had no device training and all dentists were combined |
| Arm/Group Title | No Device Practitioners |
|---|---|
| Arm/Group Description | The practitioners will not receive any additional training. |
| Measure Participants | 85 |
| Luster |
49
9.8%
|
| Color |
40
8%
|
| Risk |
29
5.8%
|
| Feel of the lesion |
31
6.2%
|
Adverse Events
| Time Frame | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||
| Arm/Group Title | 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) | ||||||
| Arm/Group Description | The practitioners will not receive any additional training. | 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. | 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. | The total number of patients in these two phases is 1000 and 0/1000 were affected. These were 2 different sets of patients. | The total number of patients in these two phases is 918 and 0/918 were affected. These were 2 different sets of patients. | The total number of patients in these two phases is 1057 and 0/1057 were affected. These were 2 different sets of patients. | ||||||
All Cause Mortality |
||||||||||||
| 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) | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/28 (0%) | 0/28 (0%) | 0/29 (0%) | 0/1000 (0%) | 0/918 (0%) | 0/1057 (0%) | ||||||
Serious 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) | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/28 (0%) | 0/28 (0%) | 0/29 (0%) | 0/1000 (0%) | 0/918 (0%) | 0/1057 (0%) | ||||||
Other (Not Including Serious) 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) | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/28 (0%) | 0/28 (0%) | 0/29 (0%) | 0/1000 (0%) | 0/918 (0%) | 0/1057 (0%) | ||||||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Sonia Makhija |
|---|---|
| Organization | National Dental PBRN |
| Phone | 2059965298 |
| smakhija@uab.edu |
- 14-003-E