Decision Aids for the Management of Suspicious Occlusal Caries Lesions

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.

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