Back to resultsOral Pathology Asynchronous Telementoring Pilot Study
Primary Purpose
Oral Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Imaging using intraoral cameras
Sponsored by
About this trial
This is an interventional prevention trial for Oral Cancer
Eligibility Criteria
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:
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.
Sites / Locations
- NYU Langone Health Dental Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dental Providers
Dental Patients
Arm 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.
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.
Outcomes
Primary Outcome Measures
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
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.
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
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 Outcome Measures
Percentage of Dental Providers Who Reported Successfully Providing the Tele-Mentoring Intervention
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.
Percentage of Dental Providers Who Reported That The Process Was Clear and Straightforward
The process includes from EHR data entry to interaction with the oral surgeon over findings to patient referral
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04166214
Brief Title
Oral Pathology Asynchronous Telementoring Pilot Study
Official Title
Oral Pathology Asynchronous Telementoring Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 14, 2020 (Actual)
Primary Completion Date
November 23, 2020 (Actual)
Study Completion Date
November 23, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dental Providers
Arm Type
Experimental
Arm 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.
Arm Title
Dental Patients
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Imaging using intraoral cameras
Other Intervention Name(s)
Aceton Soprocare Intraoral Camera
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
At the end of the dental appointment, 30-45 minutes
Title
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
Description
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.
Time Frame
At the end of the dental appointment, 30-45 minutes
Secondary Outcome Measure Information:
Title
Percentage of Dental Providers Who Reported Successfully Providing the Tele-Mentoring Intervention
Description
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.
Time Frame
At the end of the dental appointment, 30-45 minutes
Title
Percentage of Dental Providers Who Reported That The Process Was Clear and Straightforward
Description
The process includes from EHR data entry to interaction with the oral surgeon over findings to patient referral
Time Frame
At the end of the dental appointment, 30-45 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie Mohadjeri-Franck, DMD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health Dental Medicine
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11220
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing 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.
Learn more about this trial
Oral Pathology Asynchronous Telementoring Pilot Study
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