NCT04166214

Oral Pathology Asynchronous Telementoring Pilot Study

Completed NA Results posted Last updated 3 December 2021

What this trial tests

NA trial testing Imaging using intraoral cameras in Oral Cancer in 51 participants. Completed in 23 November 2020.

Timeline

14 July 2020

Primary endpoint
23 November 2020

23 November 2020

Quick facts

Lead sponsor	NYU Langone Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	51
Start date	14 July 2020
Primary completion	23 November 2020
Estimated completion	23 November 2020
Sites	1 location across United States

Drugs / interventions tested

• Imaging using intraoral cameras

Conditions studied

• Oral Cancer — all drugs for Oral Cancer →

Sponsor

NYU Langone Health — full company profile →

Who can join

18 and older, any sex, with Oral Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · 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.

Group	Value	95% CI
Dental Patients	94.9

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 Primary · 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.

Group	Value	95% CI
Dental Patients	94.8

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

Group	Value	95% CI
Dental Providers	100

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

Group	Value	95% CI
Dental Providers	100

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Feasibility and acceptability of an oral pathology asynchronous tele-mentoring intervention: A protocol.
   Northridge ME, Littlejohn T, Mohadjeri-Franck N, Gargano S, et al · · 2020 · cited 2× · PMID 32550221 · DOI 10.4081/jphr.2020.1777
2. A feasibility and acceptability study of using an intra-oral camera and an asynchronous tele-mentoring protocol to detect and identify oral lesions.
   Northridge ME, Weiserbs KF, Sabounchi SS, Torroni A, et al · · 2022 · cited 1× · PMID 36081898 · DOI 10.1177/22799036221115778