Dental Caries
Conditions
Keywords
Suspicious Occlusal Caries
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.
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.
Interventions
DEVICESpectra Device
Spectra Caries detection device is used for study data collection recording the results of the dental examination and recording results of dental treatment.
DEVICEDIAGNOdent
DIAGNOdent Caries detection device is used for study data collection recording the results of the dental examination and recording results of dental treatment.
Sponsors
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
The National Dental Practice-Based Research Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| No Device Patients Pre-intervention 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. | 500 |
| Spectra Device Patients Pre-intervention 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. | 474 |
| DIAGNOdent Device Patients Pre-intervention 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. | 526 |
| No Device Clinicians They received no device at randomization | 28 |
| Spectra Clinicians 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. | 28 |
| DIAGNOdent Clinicians 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. | 29 |
| No Device Patients Post-intervention | 525 |
| Spectra Device Patients Post-intervention | 444 |
| DIAGNOdent Device Patients Post-intervention | 531 |
| Total | 3,085 |
Baseline characteristics
| Characteristic | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous All patients and clinicians | 32.3 years STANDARD_DEVIATION 17.5 | 30.1 years STANDARD_DEVIATION 17 | 34.7 years STANDARD_DEVIATION 17.3 | NA years | NA years | NA years | 37.2 years STANDARD_DEVIATION 19.2 | 36.3 years STANDARD_DEVIATION 16.1 | 34.7 years STANDARD_DEVIATION 16.8 | 36.0 years STANDARD_DEVIATION 17.4 |
| Ethnicity (NIH/OMB) Patients and Clinicians Hispanic or Latino | 77 Participants | 73 Participants | 84 Participants | 0 Participants | 0 Participants | 1 Participants | 60 Participants | 20 Participants | 51 Participants | 366 Participants |
| Ethnicity (NIH/OMB) Patients and Clinicians Not Hispanic or Latino | 395 Participants | 391 Participants | 417 Participants | 26 Participants | 26 Participants | 28 Participants | 443 Participants | 400 Participants | 450 Participants | 2576 Participants |
| Ethnicity (NIH/OMB) Patients and Clinicians Unknown or Not Reported | 28 Participants | 10 Participants | 25 Participants | 2 Participants | 2 Participants | 0 Participants | 22 Participants | 24 Participants | 30 Participants | 143 Participants |
| Number of Patients and Clinicians | 500 Participants | 474 Participants | 526 Participants | 28 Participants | 28 Participants | 29 Participants | 525 Participants | 444 Participants | 531 Participants | 3085 Participants |
| Race (NIH/OMB) Patients and Clinicians American Indian or Alaska Native | 6 Participants | 4 Participants | 9 Participants | 1 Participants | 0 Participants | 0 Participants | 14 Participants | 15 Participants | 17 Participants | 66 Participants |
| Race (NIH/OMB) Patients and Clinicians Asian | 16 Participants | 21 Participants | 21 Participants | 3 Participants | 4 Participants | 6 Participants | 7 Participants | 1 Participants | 2 Participants | 81 Participants |
| Race (NIH/OMB) Patients and Clinicians Black or African American | 85 Participants | 72 Participants | 76 Participants | 2 Participants | 1 Participants | 3 Participants | 55 Participants | 66 Participants | 85 Participants | 445 Participants |
| Race (NIH/OMB) Patients and Clinicians More than one race | 11 Participants | 11 Participants | 6 Participants | NA Participants | NA Participants | NA Participants | 9 Participants | 4 Participants | 7 Participants | NA Participants |
| Race (NIH/OMB) Patients and Clinicians Native Hawaiian or Other Pacific Islander | 0 Participants | 4 Participants | 2 Participants | NA Participants | NA Participants | NA Participants | 4 Participants | 2 Participants | 1 Participants | NA Participants |
| Race (NIH/OMB) Patients and Clinicians Unknown or Not Reported | 29 Participants | 40 Participants | 34 Participants | 1 Participants | 3 Participants | 2 Participants | 29 Participants | 8 Participants | 31 Participants | 177 Participants |
| Race (NIH/OMB) Patients and Clinicians White | 353 Participants | 322 Participants | 378 Participants | 21 Participants | 20 Participants | 18 Participants | 407 Participants | 348 Participants | 388 Participants | 2255 Participants |
| Region of Enrollment United States | 500 patients and clinicians | 474 patients and clinicians | 526 patients and clinicians | 28 patients and clinicians | 28 patients and clinicians | 29 patients and clinicians | 525 patients and clinicians | 444 patients and clinicians | 531 patients and clinicians | 3085 patients and clinicians |
| Sex: Female, Male All patients and clinicians Female | 303 Participants | 252 Participants | 328 Participants | 11 Participants | 10 Participants | 12 Participants | 297 Participants | 269 Participants | 302 Participants | 1784 Participants |
| Sex: Female, Male All patients and clinicians Male | 197 Participants | 222 Participants | 198 Participants | 17 Participants | 18 Participants | 17 Participants | 228 Participants | 175 Participants | 229 Participants | 1301 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 28 | 0 / 29 | 0 / 1,000 | 0 / 918 | 0 / 1,057 |
| other Total, other adverse events | 0 / 28 | 0 / 28 | 0 / 29 | 0 / 1,000 | 0 / 918 | 0 / 1,057 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 | 0 / 29 | 0 / 1,000 | 0 / 918 | 0 / 1,057 |
Outcome results
Primary
Number of Lesions That Received Invasive Treatment and the Number of Lesions Receiving Invasive Treatment That Extended Into Dentin
There was one lesion/patient.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| No Device Patients in Pre-intervention | 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 |
| No Device Patients in Pre-intervention | 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 |
| No Device Patients in Pre-intervention | 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 |
| No Device Patients in Pre-intervention | 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 |
| No Device Patients Post-intervention | Number of Lesions That Received Invasive Treatment and the Number of Lesions Receiving Invasive Treatment That Extended Into Dentin | Extended into dentin : No | 76 lesions |
| No Device Patients Post-intervention | Number of Lesions That Received Invasive Treatment and the Number of Lesions Receiving Invasive Treatment That Extended Into Dentin | Extended into dentin : Yes | 151 lesions |
| No Device Patients Post-intervention | Number of Lesions That Received Invasive Treatment and the Number of Lesions Receiving Invasive Treatment That Extended Into Dentin | Invasive (yes/no) : Yes | 246 lesions |
| No Device Patients Post-intervention | Number of Lesions That Received Invasive Treatment and the Number of Lesions Receiving Invasive Treatment That Extended Into Dentin | Invasive (yes/no) : No | 277 lesions |
| Spectra Patients Post-intervention | Number of Lesions That Received Invasive Treatment and the Number of Lesions Receiving Invasive Treatment That Extended Into Dentin | Extended into dentin : Yes | 133 lesions |
| Spectra Patients Post-intervention | Number of Lesions That Received Invasive Treatment and the Number of Lesions Receiving Invasive Treatment That Extended Into Dentin | Invasive (yes/no) : No | 226 lesions |
| Spectra Patients Post-intervention | Number of Lesions That Received Invasive Treatment and the Number of Lesions Receiving Invasive Treatment That Extended Into Dentin | Extended into dentin : No | 74 lesions |
| Spectra Patients Post-intervention | Number of Lesions That Received Invasive Treatment and the Number of Lesions Receiving Invasive Treatment That Extended Into Dentin | Invasive (yes/no) : Yes | 213 lesions |
| DIAGNOdent Patients Post-intervention | Number of Lesions That Received Invasive Treatment and the Number of Lesions Receiving Invasive Treatment That Extended Into Dentin | Invasive (yes/no) : No | 276 lesions |
| DIAGNOdent Patients Post-intervention | Number of Lesions That Received Invasive Treatment and the Number of Lesions Receiving Invasive Treatment That Extended Into Dentin | Extended into dentin : No | 77 lesions |
| DIAGNOdent Patients Post-intervention | Number of Lesions That Received Invasive Treatment and the Number of Lesions Receiving Invasive Treatment That Extended Into Dentin | Invasive (yes/no) : Yes | 248 lesions |
| DIAGNOdent Patients Post-intervention | Number of Lesions That Received Invasive Treatment and the Number of Lesions Receiving Invasive Treatment That Extended Into Dentin | Extended into dentin : Yes | 144 lesions |
Secondary
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
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)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| No Device Patients in Pre-intervention | 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 |
| No Device Patients in Pre-intervention | 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 |
| No Device Patients in Pre-intervention | 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 |
| No Device Patients in Pre-intervention | 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 |
| No Device Patients in Pre-intervention | 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 |
| No Device Patients Post-intervention | 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 | 23 Participants |
| No Device Patients Post-intervention | 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 | 10 Participants |
| No Device Patients Post-intervention | 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 | 10 Participants |
| No Device Patients Post-intervention | 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 | 12 Participants |
| No Device Patients Post-intervention | 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 | 14 Participants |
| Spectra Patients Post-intervention | 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 | 27 Participants |
| Spectra Patients Post-intervention | 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 | 18 Participants |
| Spectra Patients Post-intervention | 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 | 10 Participants |
| Spectra Patients Post-intervention | 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 | 12 Participants |
| Spectra Patients Post-intervention | 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 | 11 Participants |
Secondary
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
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)
Population: Pre-intervention the dentists were not randomized and had no device training and all dentists were combined
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| No Device Patients in Pre-intervention | 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 |
| No Device Patients in Pre-intervention | 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 |
| No Device Patients in Pre-intervention | 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 |
| No Device Patients in Pre-intervention | 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 |