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Trial record 68 of 12357 for:    Oral Cancer

Oral Pathology Asynchronous Telementoring Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04166214
Recruitment Status : Not yet recruiting
First Posted : November 18, 2019
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
The purpose of the proposed research project is to evaluate and enhance the feasibility and acceptability of integrating a tele-mentoring component into the identification of oral lesions at the 6 dental clinics of Family Health Centers at NYU Langone (FHC), a Federally Qualified Health Center (FQHC) in Brooklyn, NY.

Condition or disease Intervention/treatment Phase
Oral Cancer Device: intraoral cameras Not Applicable

Detailed Description:
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. Using a mixed-methods approach, the study will evaluate and enhance the feasibility and acceptability of integrating a tele-mentoring component into the identification of oral lesions at the 6 FHC dental clinics.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oral Cancer

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Dental patients will be eligible for study participation if they meet the following criteria:

  1. Greater than or equal to 18 years of age.
  2. Live in any of the 5 boroughs of New York, NY and visit a participating FHC dental clinic for routine dental care.
  3. Able and willing to provide informed consent, have their oral lesion(s) photograph(s) and accompanying data entered into the Dentrix EHR, and participate in an exit interview.

Dental providers will be eligible for study participation if they meet the following criteria:

  1. Greater than or equal to 18 years of age.
  2. Be employed as a dentist or placed as a dental resident at a participating FHC dental clinic.
  3. Able and willing to provide informed consent and participate in feasibility testing (provider survey or semi-structured interview).

Exclusion Criteria:

Dental patients will be excluded from study participation if they meet the following criteria:

  1. Have an acute or terminal illness or a serious mental illness or any other severe health condition(s) that might preclude visiting an oral health care provider.
  2. Are currently participating in another oral health study.

Dental providers will be excluded from study participation if they meet the following criteria:

1. Have an acute or terminal illness or a serious mental illness or any other severe health condition(s) that might preclude them from completing the feasibility testing.


Information from the National Library of Medicine

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


Contacts
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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

Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Nathalie Mohadjeri-Franck, DMD NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04166214    
Other Study ID Numbers: 19-01268
First Posted: November 18, 2019    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Access Criteria: The investigator who proposed to use the data. Requests should be directed to Natalie.Mohadjeri-Franck@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases