N/A
N=3,085
Decision Aids for the Management of Suspicious Occlusal Caries Lesions
Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT02340767 ↗Enrolled (actual)
3,085
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Number of Lesions That Received Invasive Treatment and the Number of Lesions Receiving Invasive Treatment That Extended Into Dentin — 603; 246; 213; 248 lesions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Spectra Device (Device); DIAGNOdent (Device)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- The National Dental Practice-Based Research Network
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Lesions That Received Invasive Treatment and the Number of Lesions Receiving Invasive Treatment That Extended Into Dentin |
603; 246; 213; 248; 885; 277 | — |
| 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 |
15; 14; 12; 15; 12; 11 | — |
| 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 |
49; 40; 29; 31 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02340767). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.