Decision Aids for the Management of Suspicious Occlusal Caries Lesions

Dental Caries Clinical Trial

— SOCL  

Official title:

Decision Aids for the Management of Suspicious Occlusal Caries Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02340767
• Other study ID #: 14-003-E
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: December 2016

Study information

• Verified date: July 2018
• Source: The National Dental Practice-Based Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3085
• Est. completion date: December 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries

Intervention

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.
• DIAGNOdent
DIAGNOdent Caries detection device is used for study data collection recording the results of the dental examination and recording results of dental treatment.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Florida	Gainesville	Florida
United States	HealthPartners Institute for Education and Research	Minneapolis	Minnesota
United States	Kaiser Permanente Center for Health Research	Portland	Oregon
United States	University of Rochester	Rochester	New York
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (7)

Lead Sponsor	Collaborator
The National Dental Practice-Based Research Network	HealthPartners Institute, Kaiser Permanente, The University of Texas Health Science Center at San Antonio, University of Alabama at Birmingham, University of Florida, University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)

External Links

•   National Dental Practice-Based Research Network