Decision Aids for the Management of Suspicious Occlusal Caries Lesions

NCT02340767 | Completed Results DMC FDA Device

• 1 other identifier: 14-003-E
• Study Type: interventional
• Target: 3,085
• Locations: 1 country
• Sites: 6

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.

Conditions

Dental Caries

Keywords

Suspicious Occlusal Caries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

  Post-intervention (dentists completed the vignettes one time)

• 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

  Pre-intervention (dentists completed the vignettes one time)

Study Arms (3)

No Device Clinicians

NO INTERVENTION

The clinicians will not receive any additional training.

Spectra Device Clinicians

EXPERIMENTAL

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.

Device: Spectra Device

DIAGNOdent Device Practitioners

EXPERIMENTAL

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.

Device: DIAGNOdent

Interventions

Spectra Device DEVICE

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

Spectra Device Clinicians

DIAGNOdent DEVICE

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

DIAGNOdent Device Practitioners

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• The National Dental Practice-Based Research Network: lead
• Kaiser Permanente: collaborator
• HealthPartners Institute: collaborator
• The University of Texas Health Science Center at San Antonio: collaborator
• University of Alabama at Birmingham: collaborator
• University of Florida: collaborator
• University of Rochester: collaborator

Study Sites (6)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

HealthPartners Institute for Education and Research

Minneapolis, Minnesota, 55445, United States

Location

University of Rochester

Rochester, New York, 14620, United States

Location

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227-1110, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Related Links

• National Dental Practice-Based Research Network

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Dr. Sonia Makhija
• Organization: National Dental PBRN

smakhija@uab.edu

2059965298

Study Officials

• Gregg H Gilbert, DDS, MBA

  University of Alabama at Birmingham

  STUDY DIRECTOR

• Sonia K Makhija, DDS, MPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2014
• First Posted: January 19, 2015
• Study Start: December 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2016
• Last Updated: April 3, 2019
• Results First Posted: April 3, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)