Oral CancerNCT04166214
Oral Pathology Asynchronous Telementoring Pilot Study
A study testing Imaging using intraoral cameras in people with Oral Cancer, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Cancer
- What is being tested?
- Imaging using intraoral cameras
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2020to 23 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Langone Health Dental Medicine
Brooklyn, New York, 11220
About this 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.
Read the 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.
- Conditions
- Oral Cancer
- Being tested
- Imaging using intraoral cameras
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging using intraoral camerasOther
Also called Aceton Soprocare Intraoral Camera
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Imaging using intraoral cameras |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: At the end of the dental appointment, 30-45 minutes
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
Measured: At the end of the dental appointment, 30-45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start14 Jul 2020
- Primary completion23 Nov 2020
- Study completion23 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie Mohadjeri-Franck, DMD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166214
- Sponsor's protocol ID
- 19-01268
- Status last verified
- Oct 2021
- First submitted
- 14 Nov 2019
- Last updated
- 3 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Pathology Asynchronous Telementoring Pilot Study
- ClinicalTrials.gov ID
- NCT04166214
- Acronym / sponsor ID
- 19-01268
- Conditions
- Oral Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 23 Nov 2020 (actual)
- First posted
- 18 Nov 2019 (actual)
- Results
- Posted 3 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dental Providers | Experimental | Other: Imaging using intraoral camerasThe 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. |
| Dental Patients | Experimental | Other: Imaging using intraoral camerasThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imaging using intraoral camerasAlso: Aceton Soprocare Intraoral CameraThe 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 | Dental Patients, Dental Providers |
Primary outcome
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.
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.
2 secondary outcomes
Percentage of Dental Providers Who Reported Successfully Providing the Tele-Mentoring Intervention
Time frame: At the end of the dental appointment, 30-45 minutes
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie Mohadjeri-Franck, DMD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imaging using intraoral cameras in people with Oral Cancer, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.