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Completed

NCT Number: NCT04166214

Oral Pathology Asynchronous Telementoring Pilot Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health Dental Medicine

Brooklyn, New York, 11220, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • Greater than or equal to 18 years of age.
  • Live in any of the 5 boroughs of New York, NY and visit a participating FHC dental clinic for routine dental care.
  • 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:

  • Greater than or equal to 18 years of age.
  • Be employed as a dentist or placed as a dental resident at a participating FHC dental clinic.
  • 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:

  • 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.
  • Are currently participating in another oral health study.

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

  • 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.

Treatment and study plan

Imaging using intraoral cameras

Other

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 names: Aceton Soprocare Intraoral Camera

Primary outcomes

  1. Percentage of Dental Patients Who Strongly Agreed or Agreed That the Use of an Intra-Oral Camera By Their Dentists Helped Them to Better Understand Oral Cancer Screening

    Time frame: At the end of the dental appointment, 30-45 minutes

    Consented patients will be asked to complete a brief Patient Exit Survey (5 statements) at the end of their dental appointments after being screened for oral cancer lesions using an intraoral camera. Responses to the second statement are reported for this outcome measure. The statement is scored on a Likert Scale from 1 - Strongly Disagree to 5 - Strongly Agree.

  2. Percentage of Dental Patients Who Strongly Agreed or Agreed That Dentists Answered Their Questions About Oral Cancer and Were Able to Provide Them With Resources

    Time frame: At the end of the dental appointment, 30-45 minutes

    Consented patients will be asked to complete a brief Patient Exit Survey (5 statements) at the end of their dental appointments after being screened for oral cancer lesions using an intraoral camera. Responses to the fourth statement are reported for this outcome measure. The statement is scored on a Likert Scale from 1 - Strongly Disagree to 5 - Strongly Agree.

Secondary outcomes

  1. Percentage of Dental Providers Who Reported Successfully Providing the Tele-Mentoring Intervention

    Time frame: At the end of the dental appointment, 30-45 minutes

    Dentists are given a Provider "Essential Components" Checklist to fill out. This checklist summarizes the essential components of incorporating a tele-mentoring intervention into the identification of oral lesions via use of intraoral cameras to take photographs of oral lesions at chairside, uploading them into Dentrix, and conferring with an oral pathology expert.

    Successful provision of the intervention is indicated by marking "item met" for all 10 intervention elements listed in the checklist.

  2. Percentage of Dental Providers Who Reported That The Process Was Clear and Straightforward

    Time frame: At the end of the dental appointment, 30-45 minutes

    The process includes from EHR data entry to interaction with the oral surgeon over findings to patient referral

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 18, 2019
Registry last updated
Dec 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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