ONE-1 Oral graNd Est 1 (ONE)
Primary Purpose
Dental Decay, Periodontal Abscess, Periodontitis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Intra oral cameras
Sponsored by
About this trial
This is an interventional diagnostic trial for Dental Decay focused on measuring Telemedecine, Dental Camera, Nursing Home, Dental Decay, Oral Status
Eligibility Criteria
Inclusion Criteria:
- Be an adult person
- Be affiliated of granted of health insurance
- Be resident of a nursing home
- People (or the guardian) who received complete information about the research and who signed the consent form.
Exclusion Criteria:
- People deprived of their liberty by justice's decision, or people following psychiatric treatment according to articles L. 3212-1 et L. 3213-1 of the French law
- People with insufficient skills in French
- People with total bimaxillary prosthesis
- People without any teeth
Sites / Locations
- EHPAD St GeorgesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intra oral clinical examination
Arm Description
Outcomes
Primary Outcome Measures
Detection of at least one decayed tooth in the mouth of each elderly of the study
During the intra-oral examination (reference investigation)
Using video records of first camera told Soprocare®
Using video records of second camea told "wide public"
Secondary Outcome Measures
Conditions of the elderlies of the study will be evaluated thanks to the intra oral clinical examination and the video records of each of the two cameras.
The presence of at least one filled tooth, the absence of at least one tooth, the presence of gingivitis, of an abscess, of dental plaque and calculous in the elderlies of the study will be evaluated thanks to the intra oral clinical examination and the video records of each of the two cameras.
The number of decayed, filled, missing teeth in the elderly of the study will be recorded thanks to the intra oral clinical examination and the video records of each of the two cameras.
Presence of each dental conditions (at least one tooth decayed, filled, missing) and each periodontal conditions will be assess by to independent reviewers from video records of each camera.
periodontal conditions = presence of gingigivitis, abscess, dental plaque or calculous
Number of teeth showing each dental conditions (at least one tooth decayed, filled, missing) will be assess by two independent reviewers from video records of each camera.
Presence of a decayed, a filled, or missing tooth, will be assess for each tooth of elderly of the study during the clinical examination and the records of each camera.
Feeling of the patient will be evaluated thanks to a questionnaire "questionnaire of acceptability of patient's examination"
Each examination (e.g clinical exam, camera 1, camera 2) are evaluated by 8 questions rated from 1 to 6, i.e a score between 8 to 48 for each exam. The questionnaire is an adaptation of the "Whole Systems Demonstrator Service User Technology Acceptability" questionnaire from Hirani, S. P., Rixon, L., Beynon, M., Cartwright, M., Cleanthous, S., Selva, A., Sanders, C. and Newman, S. P. (2016). Quantifying beliefs regarding telehealth: Development of the Whole Systems Demonstrator Service User Technology Acceptability Questionnaire. Journal of Telemedicine and Telecare, 23(4), pp. 460-469. doi:
10.1177/1357633X16649531
Number of decayed, filled, missing teeth in the elderly of the study will be recorded thanks to the intra oral clinical examination and the video records of each of the two cameras.
Number of appointment programation
If a dental or periodontal condition has been brought to light during the intraoral clinical examination, the coordinating physician will assess by phone if the needed care have been realized during the two-month following this examination. If hasn't been realized during this two-month follow-up time, coordinating physician will record if an appointment has been programmed for this needed care.
Full Information
NCT ID
NCT05089214
First Posted
October 11, 2021
Last Updated
July 19, 2022
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT05089214
Brief Title
ONE-1 Oral graNd Est 1
Acronym
ONE
Official Title
Diagnostic Efficacy Assessment of Two Oral Telemedicine Tools Compared to Intra Oral Clinical Examination Used as a Reference: a Pilot Study in Region Grand-Est
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2022 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France
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
No
5. Study Description
Brief Summary
This study is about the assessment of two oral telemedecine tools compared to an intra oral clinical examination used as a reference among elderly persons living in nursing home. Our hyposthesis is that the diagnostic performance of the two devices will be similar.
The main goal of the study is to assess the performances of two intra-oral cameras compared to an intra oral clinical examination to detect at least one decayed tooth.
The secondary objectives of this study are :
At patient's level:
To assess the performances of two intra-oral cameras types compared to an intra oral clinical examination for detecting each of the following conditions: (i) at least one filled tooth, (ii) at least one missing tooth, (iii) gingivitis, (iv) an abscess, (v) dental plaque and (vi) calculous
To assess the concordance between each intra oral cameras and the intra oral clinical examination in the evaluation of the number (i) of decayed teeth, (ii) filled teeth and (iii) missing tooth
From video acquisitions of each intra oral cameras, to assess the inter-observer concordance for the diagnostic of each dental pathologies (presence of at least one decayed tooth, filled or missing) and periodontal (presence of gingivitis, abscess, dental plaque or scale)
From video acquisitions of each intra oral cameras, to assess the inter-observer agreement of the number of teeth: (i) decayed, (ii) filled and (ii) missing
At tooth level :
To assess the performances of two intra-oral cameras types compared to an intra oral clinical examination for detecting each of the following conditions: (i) a cavity, (ii) a filled tooth and (iii) missing tooth
In all patients :
To assess patient's feelings about the use of each intra oral cameras
To compare the time required for video acquisitions between each of intra oral cameras
For patients with dental or periodontal pathologies observed during the intra oral examination:
8 To assess, 2 months after initial evaluation, the proportion of patients attended dental or periodontal care and for which an appointment with a dentist has been scheduled
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Decay, Periodontal Abscess, Periodontitis, Gingivitis, Dental Plaque, Calculus, Dental, Missing Teeth
Keywords
Telemedecine, Dental Camera, Nursing Home, Dental Decay, Oral Status
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intra oral clinical examination
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Intra oral cameras
Intervention Description
Diagnostic comparison of two intra oral cameras
Primary Outcome Measure Information:
Title
Detection of at least one decayed tooth in the mouth of each elderly of the study
Description
During the intra-oral examination (reference investigation)
Using video records of first camera told Soprocare®
Using video records of second camea told "wide public"
Time Frame
within 2 weeks
Secondary Outcome Measure Information:
Title
Conditions of the elderlies of the study will be evaluated thanks to the intra oral clinical examination and the video records of each of the two cameras.
Description
The presence of at least one filled tooth, the absence of at least one tooth, the presence of gingivitis, of an abscess, of dental plaque and calculous in the elderlies of the study will be evaluated thanks to the intra oral clinical examination and the video records of each of the two cameras.
Time Frame
within 2 weeks
Title
The number of decayed, filled, missing teeth in the elderly of the study will be recorded thanks to the intra oral clinical examination and the video records of each of the two cameras.
Time Frame
within 2 weeks
Title
Presence of each dental conditions (at least one tooth decayed, filled, missing) and each periodontal conditions will be assess by to independent reviewers from video records of each camera.
Description
periodontal conditions = presence of gingigivitis, abscess, dental plaque or calculous
Time Frame
within 2 weeks
Title
Number of teeth showing each dental conditions (at least one tooth decayed, filled, missing) will be assess by two independent reviewers from video records of each camera.
Time Frame
within 2 weeks
Title
Presence of a decayed, a filled, or missing tooth, will be assess for each tooth of elderly of the study during the clinical examination and the records of each camera.
Time Frame
within 2 weeks
Title
Feeling of the patient will be evaluated thanks to a questionnaire "questionnaire of acceptability of patient's examination"
Description
Each examination (e.g clinical exam, camera 1, camera 2) are evaluated by 8 questions rated from 1 to 6, i.e a score between 8 to 48 for each exam. The questionnaire is an adaptation of the "Whole Systems Demonstrator Service User Technology Acceptability" questionnaire from Hirani, S. P., Rixon, L., Beynon, M., Cartwright, M., Cleanthous, S., Selva, A., Sanders, C. and Newman, S. P. (2016). Quantifying beliefs regarding telehealth: Development of the Whole Systems Demonstrator Service User Technology Acceptability Questionnaire. Journal of Telemedicine and Telecare, 23(4), pp. 460-469. doi:
10.1177/1357633X16649531
Time Frame
within 2 weeks
Title
Number of decayed, filled, missing teeth in the elderly of the study will be recorded thanks to the intra oral clinical examination and the video records of each of the two cameras.
Time Frame
within 2 weeks
Title
Number of appointment programation
Description
If a dental or periodontal condition has been brought to light during the intraoral clinical examination, the coordinating physician will assess by phone if the needed care have been realized during the two-month following this examination. If hasn't been realized during this two-month follow-up time, coordinating physician will record if an appointment has been programmed for this needed care.
Time Frame
within 2 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Be an adult person
Be affiliated of granted of health insurance
Be resident of a nursing home
People (or the guardian) who received complete information about the research and who signed the consent form.
Exclusion Criteria:
People deprived of their liberty by justice's decision, or people following psychiatric treatment according to articles L. 3212-1 et L. 3213-1 of the French law
People with insufficient skills in French
People with total bimaxillary prosthesis
People without any teeth
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Celine CLEMENT, DDS, PhD
Phone
+ 33 6 62 73 79 47
Email
celine.clement@univ-lorraine.fr
Facility Information:
Facility Name
EHPAD St Georges
City
Hannonville sous les Côtes
ZIP/Postal Code
55210
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Céline CLEMENT
12. IPD Sharing Statement
Plan to Share IPD
No
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ONE-1 Oral graNd Est 1
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