Oral Pathology Asynchronous Telementoring Pilot Study

NCT04166214 | Completed Results DMC

• 1 other identifier: 19-01268
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  At the end of the dental appointment, 30-45 minutes

• 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.

  At the end of the dental appointment, 30-45 minutes

Secondary Outcomes (2)

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

  At the end of the dental appointment, 30-45 minutes

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

  At the end of the dental appointment, 30-45 minutes

Study Arms (2)

Dental Providers

EXPERIMENTAL

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.

Other: Imaging using intraoral cameras

Dental Patients

EXPERIMENTAL

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.

Other: Imaging using intraoral cameras

Interventions

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.

Also known as: Aceton Soprocare Intraoral Camera

Dental Patients; Dental Providers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health Dental Medicine

Brooklyn, New York, 11220, United States

Location

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Mary E. Northridge, PhD, MPH, Director of Dental Research
• Organization: NYU Langone Health - Hansjörg Wyss Department of Plastic Surgery

Mary.Northridge@nyulangone.org

347-377-4342

Study Officials

• Nathalie Mohadjeri-Franck, DMD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 18, 2019
• Study Start: July 14, 2020
• Primary Completion: November 23, 2020
• Study Completion: November 23, 2020
• Last Updated: December 3, 2021
• Results First Posted: December 3, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (1)