Decision Aids for the Management of Suspicious Occlusal Caries Lesions

Status Completed

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Dental Caries

Clinical Trial Details

NCT number	NCT02340767
Study type	Interventional
Source	The National Dental Practice-Based Research Network
Contact
Status	Completed
Phase	N/A
Start date	December 2014
Completion date	December 2016

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Decision Aids for the Management of Suspicious Occlusal Caries Lesions — SOCL

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms