Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 12:52 AM
NCT ID:
NCT02340767
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT02340767
Study Brief:
Protocol Section:
NCT02340767