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
1 other identifier
interventional
50
1 country
1
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:
- 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
- 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
- 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2021
CompletedFirst Posted
Study publicly available on registry
October 22, 2021
CompletedStudy Start
First participant enrolled
June 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedJuly 22, 2022
July 1, 2022
6 months
October 11, 2021
July 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
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 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
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
- +3 more secondary outcomes
Study Arms (1)
Intra oral clinical examination
EXPERIMENTALInterventions
Diagnostic comparison of two intra oral cameras
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
EHPAD St Georges
Hannonville-sous-les-Côtes, 55210, France
Related Publications (1)
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.
PMID: 37012012DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Dental Public Health Department
Study Record Dates
First Submitted
October 11, 2021
First Posted
October 22, 2021
Study Start
June 16, 2022
Primary Completion
December 1, 2022
Study Completion
February 1, 2023
Last Updated
July 22, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share