ONE-1 Oral graNd Est 1

Central Hospital, Nancy, France

Status: Enrolling

Conditions: Periodontitis; Dental Plaque; Periodontal Abscess; Missing Teeth; Calculus, Dental; Gingivitis; Dental Decay

Treatments: Device: Intra oral cameras

Study type: Interventional

Funder types: Other

Identifiers

NCT05089214

2021-A01306-35

Details and patient eligibility

About

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:

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

Enrollment: 50 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Intra oral clinical examination

Experimental group

Treatment:

Device: Intra oral cameras