ONE-1 Oral graNd Est 1 (ONE)

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

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

Study Overview

• Status: Recruiting
• Conditions: Periodontitis; Gingivitis; Dental Plaque; Missing Teeth; Dental Decay; Calculus, Dental; Periodontal Abscess
• Intervention / Treatment: Device: Intra oral cameras

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Celine CLEMENT, DDS, PhD; Phone Number: + 33 6 62 73 79 47; Email: celine.clement@univ-lorraine.fr

Study Locations

• France
  • Hannonville sous les Côtes, France, 55210
    • Recruiting
    • EHPAD St Georges
    • Contact: Céline Clément

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of at least one decayed tooth in the mouth of each elderly of the study	During the intra-oral examination (reference investigation); Using video records of first camera told Soprocare®; Using video records of second camea told "wide public"	within 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	periodontal conditions = presence of gingigivitis, abscess, dental plaque or calculous	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"	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	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	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.	within 2 weeks

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: October 11, 2021
• First Submitted That Met QC Criteria: October 21, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Nursing Home; Telemedecine; Dental Decay; Dental Camera; Oral Status
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Pathological Conditions, Anatomical; Gingival Diseases; Tooth Demineralization; Tooth Diseases; Suppuration; Dental Deposits; Abscess; Periodontitis; Gingivitis; Dental Caries; Calculi; Dental Plaque; Dental Calculus; Periodontal Abscess
• Other Study ID Numbers: 2021-A01306-35

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No