Oral Pathology Asynchronous Telementoring Pilot Study
Oral Pathology Asynchronous Telementoring Pilot Study
Sponsors
Source
NYU Langone Health
Oversight Info
Has Dmc
Yes
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
Is Us Export
No
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.
Overall Status
Not yet recruiting
Start Date
2020-01-01
Completion Date
2021-01-01
Primary Completion Date
2020-11-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Change in the feasibility of tele-mentoring intervention |
3 to 6 months |
|
Change in the feasibility of tele-mentoring intervention |
3 to 6 months |
Secondary Outcome
Measure |
Time Frame |
|
Acceptability of the integrated intervention |
At the end of the 1 day dental appointment |
Enrollment
48
Condition
Intervention
Intervention Type
Device
Intervention Name
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.
Arm Group Label
tele-mentoring intervention
Other Name
Aceton Soprocare Intraoral Camera
Eligibility
Criteria
Inclusion Criteria:
Dental patients will be eligible for study participation if they meet the following
criteria:
1. Greater than or equal to 18 years of age.
2. Live in any of the 5 boroughs of New York, NY and visit a participating FHC dental
clinic for routine dental care.
3. 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:
1. Greater than or equal to 18 years of age.
2. Be employed as a dentist or placed as a dental resident at a participating FHC dental
clinic.
3. 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:
1. 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.
2. 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.
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
Accepts Healthy Volunteers
Overall Official
Last Name |
Role |
Affiliation |
|
Nathalie Mohadjeri-Franck, DMD |
Principal Investigator |
NYU Langone Health |
Overall Contact
Verification Date
2019-11-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Has Expanded Access
No
Condition Browse
Number Of Arms
1
Arm Group
Arm Group Label
tele-mentoring intervention
Arm Group Type
Experimental
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.
Firstreceived Results Date
N/A
Overall Contact Backup
Patient Data
Sharing Ipd
Yes
Ipd Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Ipd Info Type
Study Protocol
Statistical Analysis Plan (SAP)
Ipd Time Frame
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Ipd Access Criteria
The investigator who proposed to use the data. Requests should be directed to [email protected] To gain access, data requestors will need to sign a data access agreement.
Firstreceived Results Disposition Date
N/A
Study Design Info
Intervention Model
Single Group Assignment
Primary Purpose
Prevention
Masking
None (Open Label)
Study First Submitted
November 14, 2019
Study First Submitted Qc
November 15, 2019
Study First Posted
November 18, 2019
Last Update Submitted
November 15, 2019
Last Update Submitted Qc
November 15, 2019
Last Update Posted
November 18, 2019
ClinicalTrials.gov processed this data on December 06, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.