ONE-1 Oral graNd Est 1

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Recruiting

CT.gov ID

NCT05089214

Collaborator

(none)

Enrollment

Location

Arm

7.6

Anticipated Duration (Months)

6.6

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Dental Decay Periodontal Abscess Periodontitis Gingivitis Dental Plaque Calculus, Dental Missing Teeth	Device: Intra oral cameras	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

Jun 16, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intra oral clinical examination	Device: Intra oral cameras Diagnostic comparison of two intra oral cameras

Arm

Intervention/Treatment

Experimental: Intra oral clinical examination

Device: Intra oral cameras

Diagnostic comparison of two intra oral cameras

Outcome Measures

Primary Outcome Measures

Detection of at least one decayed tooth in the mouth of each elderly of the study [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 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. [within 2 weeks]
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. [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]
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. [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]
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. [within 2 weeks]
Number of appointment programation [within 2 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

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