ONE-1 Oral graNd Est 1

NCT ID: NCT05089214

Last Updated: 2022-07-22

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-16

Study Completion Date

2023-02-28

Brief Summary

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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

Detailed Description

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Conditions

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Dental Decay Periodontal Abscess Periodontitis Gingivitis Dental Plaque Calculus, Dental Missing Teeth

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Intra oral clinical examination

Group Type EXPERIMENTAL

Intra oral cameras

Intervention Type DEVICE

Diagnostic comparison of two intra oral cameras

Interventions

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Intra oral cameras

Diagnostic comparison of two intra oral cameras

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Dr. Céline CLEMENT

Head of Dental Public Health Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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EHPAD St Georges

Hannonville-sous-les-Côtes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Celine CLEMENT, DDS, PhD

Role: CONTACT

+ 33 6 62 73 79 47

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.

Reference Type DERIVED
PMID: 37012012 (View on PubMed)

Other Identifiers

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2021-A01306-35

Identifier Type: -

Identifier Source: org_study_id

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