Dental CariesSOCLNCT02340767
Decision Aids for the Management of Suspicious Occlusal Caries Lesions
A study testing Spectra Device and DIAGNOdent in people with Dental Caries, run by The National Dental Practice-Based Research Network at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Spectra Device and DIAGNOdent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,085 participants
- Where
- 6 sitesUnited States
- Study dates
- Dec 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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).
Show all 21Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of Florida
Gainesville, Florida, 32610
HealthPartners Institute for Education and Research
Minneapolis, Minnesota, 55445
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227-1110
University of Rochester
Rochester, New York, 14620
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
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.
Read the 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.
- Conditions
- Dental Caries
- Being tested
- Spectra Device, DIAGNOdent
- Keywords
- Suspicious Occlusal Caries
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectra DeviceDevice
Spectra Caries detection device is used for study data collection recording the results of the dental examination and recording results of dental treatment.
DIAGNOdentDevice
DIAGNOdent Caries detection device is used for study data collection recording the results of the dental examination and recording results of dental treatment.
| Study group | Role | What they receive |
|---|---|---|
| No Device Clinicians | No intervention | The clinicians will not receive any additional training. |
| Spectra Device Clinicians | Experimental | 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. Receives: Device: Spectra Device |
| DIAGNOdent Device Practitioners | Experimental | 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. Receives: Device: DIAGNOdent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Lesions That Received Invasive Treatment and the Number of Lesions Receiving Invasive Treatment That Extended Into Dentin
There was one lesion/patient.
Measured: Pre-intervention and post-intervention (one day visit)
Secondary outcomes (2)
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.
Measured: Post-intervention (dentists completed the vignettes one time)
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.
Measured: Pre-intervention (dentists completed the vignettes one time)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionJun 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,085 participants (actual)
Sponsor and investigators
- Lead sponsor
- The National Dental Practice-Based Research Network
- Sponsor type
- Research network
- Collaborators
- 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
- Responsible party
- Sponsor
- Investigators
- Gregg H Gilbert, DDS, MBA, Study director, University of Alabama at BirminghamSonia K Makhija, DDS, MPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340767
- Sponsor's protocol ID
- 14-003-E
- Acronym
- SOCL
- Status last verified
- Jul 2018
- First submitted
- 30 Dec 2014
- Last updated
- 3 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision Aids for the Management of Suspicious Occlusal Caries Lesions
- ClinicalTrials.gov ID
- NCT02340767
- Acronym / sponsor ID
- SOCL / 14-003-E
- Conditions
- Dental Caries
- Keywords
- Suspicious Occlusal Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,085 participants (actual)
- Lead sponsor
- The National Dental Practice-Based Research NetworkResearch network
- Collaborators
- 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
- Study start
- Dec 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Posted 3 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Device Clinicians | No intervention | –The clinicians will not receive any additional training. |
| Spectra Device Clinicians | Experimental | Device: Spectra DeviceThe 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. |
| DIAGNOdent Device Practitioners | Experimental | Device: DIAGNOdentThe 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. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (21 listed)
- 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;
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spectra DeviceSpectra Caries detection device is used for study data collection recording the results of the dental examination and recording results of dental treatment. | Device | Spectra Device Clinicians |
| DIAGNOdentDIAGNOdent Caries detection device is used for study data collection recording the results of the dental examination and recording results of dental treatment. | Device | DIAGNOdent Device Practitioners |
Primary outcome
Number of Lesions That Received Invasive Treatment and the Number of Lesions Receiving Invasive Treatment That Extended Into Dentin
Time frame: Pre-intervention and post-intervention (one day visit)
There was one lesion/patient.
2 secondary outcomes
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
Time frame: Post-intervention (dentists completed the vignettes one time)
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
Time frame: Pre-intervention (dentists completed the vignettes one time)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- National Dental Practice-Based Research NetworkLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregg H Gilbert, DDS, MBA study director
University of Alabama at Birmingham
Sonia K Makhija, DDS, MPH principal investigator
University of Alabama at Birmingham
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spectra Device and DIAGNOdent in people with Dental Caries, run by The National Dental Practice-Based Research Network at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Lesions That Received Invasive Treatment and the Number of Lesions Receiving Invasive Treatment That Extended Into Dentin (time frame: Pre-intervention and post-intervention (one day visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2019.