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
Overview
- Phase
- Not Applicable
- Sponsor
- Central Hospital, Nancy, France
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Detection of at least one decayed tooth in the mouth of each elderly of the study
Overview
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 : 5. 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 : 6. To assess patient's feelings about the use of each intra oral cameras 7. 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Detection of at least one decayed tooth in the mouth of each elderly of the study
Time Frame: within 2 weeks
* 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 Outcomes
- 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.(within 2 weeks)
- 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.(within 2 weeks)
- 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.(within 2 weeks)
- 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.(within 2 weeks)
- 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.(within 2 weeks)
- Feeling of the patient will be evaluated thanks to a questionnaire "questionnaire of acceptability of patient's examination"(within 2 weeks)
- 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.(within 2 weeks)
- Number of appointment programation(within 2 weeks)
Investigators
Dr. Céline CLEMENT
Head of Dental Public Health Department
Central Hospital, Nancy, France