Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2022-06-16
2023-02-28
Brief Summary
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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:
1. 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
2. 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
3. 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)
4. 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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Intra oral clinical examination
Intra oral cameras
Diagnostic comparison of two intra oral cameras
Interventions
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Intra oral cameras
Diagnostic comparison of two intra oral cameras
Eligibility Criteria
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Inclusion Criteria
* 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 with insufficient skills in French
* People with total bimaxillary prosthesis
* People without any teeth
ALL
Yes
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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Dr. Céline CLEMENT
Head of Dental Public Health Department
Locations
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EHPAD St Georges
Hannonville-sous-les-Côtes, , France
Countries
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Central Contacts
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Facility Contacts
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Céline CLEMENT
Role: primary
References
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Veynachter T, Sural Y, Baudot P, Remen T, Baudet A, Kabuth B, Clement C. Diagnostic performance of two teledentistry tools in elderly care facilities: the ONE-1 protocol for a pilot prospective diagnostic study. BMJ Open. 2023 Apr 3;13(4):e063906. doi: 10.1136/bmjopen-2022-063906.
Other Identifiers
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2021-A01306-35
Identifier Type: -
Identifier Source: org_study_id
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