Decision Aids for the Management of Suspicious Occlusal Caries Lesions

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.

Conditions

• Dental Caries

Interventions

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.

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.

Sponsors & Collaborators

• Kaiser Permanente

  collaborator OTHER

• HealthPartners Institute

  collaborator OTHER

• The University of Texas Health Science Center at San Antonio

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• University of Florida

  collaborator OTHER

• University of Rochester

  collaborator OTHER

• The National Dental Practice-Based Research Network

  lead NETWORK

Principal Investigators

• Gregg H Gilbert, DDS, MBA · University of Alabama at Birmingham

• Sonia K Makhija, DDS, MPH · University of Alabama at Birmingham

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-12-31

Primary Completion

2015-06-30

Completion

2016-12-31

FDA Device

Yes

Countries

• United States

Study Locations