Decision Aids for the Management of Suspicious Occlusal Caries Lesions (SOCL)

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Device: Spectra Device; Device: DIAGNOdent

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 Type: Interventional
• Enrollment (Actual): 3085
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida
  • Minnesota
    • Minneapolis, Minnesota, United States, 55445
      • HealthPartners Institute for Education and Research
  • New York
    • Rochester, New York, United States, 14620
      • University of Rochester
  • Oregon
    • Portland, Oregon, United States, 97227-1110
      • Kaiser Permanente Center for Health Research
  • Texas
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center at San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Lesions That Received Invasive Treatment and the Number of Lesions Receiving Invasive Treatment That Extended Into Dentin	There was one lesion/patient.	Pre-intervention and post-intervention (one day visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Pre-intervention (dentists completed the vignettes one time)

Collaborators and Investigators

• Sponsor: The National Dental Practice-Based Research Network
• Collaborators: University of Alabama at Birmingham; University of Florida; University of Rochester; HealthPartners Institute; Kaiser Permanente; The University of Texas Health Science Center at San Antonio
• Investigators: Study Director: Gregg H Gilbert, DDS, MBA, University of Alabama at Birmingham

Publications and helpful links

Helpful Links

• National Dental Practice-Based Research Network

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (ACTUAL): June 1, 2015
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: December 30, 2014
• First Submitted That Met QC Criteria: January 13, 2015
• First Posted (ESTIMATE): January 19, 2015

Study Record Updates

• Last Update Posted (ACTUAL): April 3, 2019
• Last Update Submitted That Met QC Criteria: April 1, 2019
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Suspicious Occlusal Caries
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 14-003-E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes