ONE-1 Oral graNd Est 1

Periodontitis Clinical Trial

— ONE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05089214
• Other study ID #: 2021-A01306-35
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2022
• Est. completion date: February 2023

Study information

• Verified date: July 2022
• Source: Central Hospital, Nancy, France
• Contact: Celine CLEMENT, DDS, PhD
• Phone: + 33 6 62 73 79 47
• Email: celine.clement[@]univ-lorraine.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Calculus, Dental
• Dental Calculus
• Dental Caries
• Dental Decay
• Dental Plaque
• Gingivitis
• Missing Teeth
• Periodontitis

Intervention

Device:
• Intra oral cameras
Diagnostic comparison of two intra oral cameras

Locations

Country	Name	City	State
France	EHPAD St Georges	Hannonville sous les Côtes

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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