Clinical trial NCT02340767: Decision Aids for the Management of Suspicious Occlusal Caries Lesions
Official title: Decision Aids for the Management of Suspicious Occlusal Caries Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: Suspicious Occlusal Caries
Lead sponsor: The National Dental Practice-Based Research Network
Sponsor class: NETWORK
Collaborators: name: Kaiser Permanente
name: HealthPartners Institute
name: The University of Texas Health Science Center at San Antonio
name: University of Alabama at Birmingham
name: University of Florida
name: University of Rochester
First posted: 2015-01-19
Enrollment: 3085
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Number of Lesions That Received Invasive Treatment and the Number of Lesions Receiving Invasive Treatment That Extended Into Dentin
timeFrame: Pre-intervention and post-intervention (one day visit)
Secondary outcomes:
measure: 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
timeFrame: Post-intervention (dentists completed the vignettes one time)
measure: 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
timeFrame: Pre-intervention (dentists completed the vignettes one time)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Minneapolis
country: United States
facility: HealthPartners Institute for Education and Research
state: Minnesota
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research
state: Oregon
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: University of Alabama at Birmingham
name: Gregg H Gilbert, DDS, MBA
role: STUDY_DIRECTOR
affiliation: University of Alabama at Birmingham
name: Sonia K Makhija, DDS, MPH
role: PRINCIPAL_INVESTIGATOR
References: