Oral Pathology Asynchronous Telementoring Pilot Study
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|ClinicalTrials.gov Identifier: NCT04166214|
Recruitment Status : Not yet recruiting
First Posted : November 18, 2019
Last Update Posted : November 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Oral Cancer||Device: intraoral cameras||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Oral Pathology Asynchronous Telementoring Pilot Study|
|Estimated Study Start Date :||January 2020|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||January 2021|
Experimental: tele-mentoring intervention
The tele-mentoring intervention involves training dental faculty members and residents to use intraoral cameras to take photographs of oral lesions and place them in the Dentrix electronic health record (EHR), along with descriptions of the lesions.
Device: intraoral cameras
The SOPROCARE is intended for clinical practice of general dentistry, as an aid in the diagnosis of pit and fissure caries, as an aid to highlight dental plaque and gingival inflammations and as intra-oral camera to visualize anatomical details that are invisible to the naked eye or with a mirror. In CARIO mode, the camera helps the dental practitioner to highlight carious warning on pits and fissures of the occlusal side of the teeth. In DAYLIGHT mode, the camera enables you to visualize anatomical details invisible to the naked eye or with a mirror. In PERIO mode, the camera helps the dental practitioner to see the presence of dental plaque but also to highlight gingival inflammations . This mode offers to the dentist and/or hygienist a tool for an improved communication, motivation and education of his/her patients, who will then become aware of their oral health condition.
Other Name: Aceton Soprocare Intraoral Camera
- Change in the feasibility of tele-mentoring intervention [ Time Frame: 3 to 6 months ]Feasibility of the integrated intervention will be assessed through dental provider surveys and semi-structured interviews. The dental provider survey, which consists of a checklist of 10 key components of the tele-mentoring intervention to be implemented, will be completed by 2 dentists at each of the 6 FHC dental clinics (n=12) after screening at least 1 patient subject for oral cancer using an intraoral camera, as per the tele-mentoring protocol.
- Change in the feasibility of tele-mentoring intervention [ Time Frame: 3 to 6 months ]engage 6 dental residents (1 at each of the 6 FHC dental clinics) in a semi-structured interview to assess specific barriers they have encountered to sustaining the intervention and strategies for addressing those barriers to facilitate integration of the tele-mentoring intervention into the routine workflow of the dental clinics.The semi-structures interviews with dental resident subjects will take 30-45 minutes to complete, and will be digitally recorded and transcribed. The transcriptions will be stored in a secure REDCap database. The digital files will be deleted once they are transcribed. No identifying information will be recorded.
- Acceptability of the integrated intervention [ Time Frame: At the end of the 1 day dental appointment ]Consented participants will be asked to complete a brief patient exit survey at the end of their dental appointments after being screening for oral cancer lesions using an intraoral camera.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04166214
|Contact: Nathalie Mohadjeri-Franck, DMD||(718) 630-8224||Natalie.Mohadjeri-Franck@nyulangone.org|
|Contact: Mary E Northridge, PhD, MPH||(347) 377-4342||Mary.Northridge@nyulangone.org|
|Principal Investigator:||Nathalie Mohadjeri-Franck, DMD||NYU Langone Health|