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Decision Aids for the Management of Suspicious Occlusal Caries Lesions (SOCL)

Primary Purpose

Dental Caries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spectra Device
DIAGNOdent
Sponsored by
The National Dental Practice-Based Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dental Caries focused on measuring Suspicious Occlusal Caries

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • University of Florida
  • HealthPartners Institute for Education and Research
  • University of Rochester
  • Kaiser Permanente Center for Health Research
  • University of Texas Health Science Center at San Antonio

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

No Device Clinicians

Spectra Device Clinicians

DIAGNOdent Device Practitioners

Arm Description

The clinicians will not receive any additional training.

The clinicians in the Spectra Device Arm will be trained to the device according to the manufacturers' usual care for training. The training will consist of viewing the manufacturer's instructions for the device. Training will also consist of clinicians familiarizing themselves with the device through unsupervised clinical use with patients.

The clinicians in the DIAGNOdent Device Arm will be trained to the device according to the manufacturers' usual care for training. The training will consist of viewing the manufacturer's instructions for the device. Training will also consist of clinicians familiarizing themselves with the device through unsupervised clinical use with patients.

Outcomes

Primary Outcome Measures

Number of Lesions That Received Invasive Treatment and the Number of Lesions Receiving Invasive Treatment That Extended Into Dentin
There was one lesion/patient.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 30, 2014
Last Updated
April 1, 2019
Sponsor
The National Dental Practice-Based Research Network
Collaborators
Kaiser Permanente, HealthPartners Institute, The University of Texas Health Science Center at San Antonio, University of Alabama at Birmingham, University of Florida, University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT02340767
Brief Title
Decision Aids for the Management of Suspicious Occlusal Caries Lesions
Acronym
SOCL
Official Title
Decision Aids for the Management of Suspicious Occlusal Caries Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The National Dental Practice-Based Research Network
Collaborators
Kaiser Permanente, HealthPartners Institute, The University of Texas Health Science Center at San Antonio, University of Alabama at Birmingham, University of Florida, University of Rochester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Suspicious Occlusal Caries

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3085 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Device Clinicians
Arm Type
No Intervention
Arm Description
The clinicians will not receive any additional training.
Arm Title
Spectra Device Clinicians
Arm Type
Experimental
Arm Description
The clinicians in the Spectra Device Arm will be trained to the device according to the manufacturers' usual care for training. The training will consist of viewing the manufacturer's instructions for the device. Training will also consist of clinicians familiarizing themselves with the device through unsupervised clinical use with patients.
Arm Title
DIAGNOdent Device Practitioners
Arm Type
Experimental
Arm Description
The clinicians in the DIAGNOdent Device Arm will be trained to the device according to the manufacturers' usual care for training. The training will consist of viewing the manufacturer's instructions for the device. Training will also consist of clinicians familiarizing themselves with the device through unsupervised clinical use with patients.
Intervention Type
Device
Intervention Name(s)
Spectra Device
Intervention Description
Spectra Caries detection device is used for study data collection recording the results of the dental examination and recording results of dental treatment.
Intervention Type
Device
Intervention Name(s)
DIAGNOdent
Intervention Description
DIAGNOdent Caries detection device is used for study data collection recording the results of the dental examination and recording results of dental treatment.
Primary Outcome Measure Information:
Title
Number of Lesions That Received Invasive Treatment and the Number of Lesions Receiving Invasive Treatment That Extended Into Dentin
Description
There was one lesion/patient.
Time Frame
Pre-intervention and post-intervention (one day visit)
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Post-intervention (dentists completed the vignettes one time)
Title
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
Description
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.
Time Frame
Pre-intervention (dentists completed the vignettes one time)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregg H Gilbert, DDS, MBA
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sonia K Makhija, DDS, MPH
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
HealthPartners Institute for Education and Research
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55445
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Kaiser Permanente Center for Health Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227-1110
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://NationalDentalPBRN.org
Description
National Dental Practice-Based Research Network

Learn more about this trial

Decision Aids for the Management of Suspicious Occlusal Caries Lesions

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