Main Features of the Application
Documentation of the Oral Examination
- Manual entry of clinical observations made by the examiner (visible condition of mucosa, teeth, dentures, patient comfort, etc.).
- Addition of photographs taken by the examiner, directly integrated into the form to illustrate the observations.
- Recording of contextual information such as oral hygiene habits, denture presence and any patient-reported complaints.
Structured Information
- Organisation of information according to the usual steps of an oral examination, helping ensure completeness.
- Use of predefined structured fields (e.g. “present/absent”, “satisfactory/to monitor”) for consistent documentation.
- Easier comparison of consecutive examinations through standardised data format.
Facilitating Communication and Traceability
- Secure transmission of the completed form to a dentist or other healthcare professional when needed.
- Possibility to generate a summary document (e.g., in PDF format) for archiving in the facility’s medical record system.
- Access to the examination history of a given resident in order to follow the documented evolution of their oral health status over successive assessments.
Support for the examiner
- Structured reminders of the steps of the oral examination to guide and support the examiner’s workflow.
- Indication of the areas to be documented or photographed (e.g., dental arches, tongue, oral mucosa, dentures), with no automated analysis or interpretation of the images.
- Provision of a standardized data-entry framework to reinforce the quality and consistency of clinical documentation.
Use in Care Facilities
The Odontoscope® application can be used in a variety of healthcare environments, including residential care settings such as nursing homes or long-term care facilities.
In these contexts, the application serves exclusively as a support tool for documenting manually entered observations made by care staff or by a healthcare professional. It performs no clinical monitoring, no data analysis and does not replace the examination conducted by the dentist.
Use in Human Tele-expertise
The Odontoscope® application may be used to transmit a completed form to a dentist for human tele-expertise.
- Care staff enter observations and attach photographs.
- The form is securely forwarded to the dentist.
- The dentist remains entirely responsible for the clinical interpretation and any conclusions.
The application does not participate in this analysis and does not modify the transmitted information.
Functional Limitations – What the Application Does Not Do
To comply with its regulatory positioning as a Class I medical device software, the Odontoscope® application includes intentional limitations.
No Automated Analysis
- The application performs no automated analysis of photographs.
- It does not detect lesions or pathologies.
- No decision-support algorithms or AI are used.
No Diagnostic or Clinical Decision Support
- The application provides no diagnosis.
- It does not propose any treatment or automated triage.
- It does not compute any automated clinical scores.
Role of the Healthcare Professional
- Interpretation of all information remains solely with the clinician.
- The application does not replace direct clinical examination.
Link with the Odontoscope® Examination Mirror
The application can be used with or without the Odontoscope® examination mirror. It does not control the physical device and functions independently as a digital documentation tool.
Security and Data Protection
- Secure data transmission.
- Hosting within the European Union, GDPR-compliant.
- Access restricted to authorised users only.
Regulatory information
The Odontoscope® application is a Class I medical device software (EU Regulation 2017/745). It is intended for the structured documentation of oral examinations performed by healthcare professionals and does not perform any automated analysis.