Assessment of Dental Pathologies Using Digital Tools
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRecherche Clinique en Odontologie (ReCOL)
About this trial
Digital technology is playing an increasingly important role in dentistry, because of its ability to support the practitioner and increase work efficiency.
Among digital tools, orthopantomogram (OPT or panoramic) radiography is currently the most widely used. It provides a global view of the jaws, highlighting internal structures in 2D.
As in other fields, scientific advances have made it possible to go beyond the limited representation of two planes of space and obtain 3D images.
The intraoral scanner (IOS) or "optical impression camera" appeared in the mid-80s. They use light to create a digital optical impression that reproduces the surface of external anatomical structures in 3D images. It improves dental practice, making impressions less uncomfortable for patients, saving clinical time, facilitating storage and archiving, and facilitating transmission to the prosthetist where appropriate. This type of device is already well established in dental practices.
More recently, Cone Beam Computed Tomography (CBCT) has also begun to develop. This 3D sectional imaging technique adds an extra dimension to the exploration of internal structures.
Imaging examinations provide additional information to that obtained from the visual clinical oral examination. Together, they help the practitioner to establish the diagnosis and treatment plan.
Currently, visual information has to be collected manually. Collecting this data represents a significant amount of information. Its quality and completeness are crucial to the success of the treatment.
Given the high volume of consultations, and practitioners' need to optimize their time, it would be interesting to assess whether optical impressions, at least in part, could help to acquire this clinical data more systematically and more rapidly, in order to improve patient management.
Similarly, Cone Beam CT (CBCT), with its 3D data, improves the accuracy of diagnostic information. It would also be interesting to assess the real added value of this examination.
The RESTODATA-NUM study follows on from the RESTODATA study, the results of which provided recent information on the oral status of adult patients, and their care needs.
The aim of this study is to compare the performance of a standard real-life examination by the practitioner combining clinical and radiographic examinations (referred to here as practitioner-on-patient detection) on the one hand, and an examination based on imaging results obtained using digital tools on the other, in terms of detecting dental condition in a sample of adult patients consulting for an oral examination at one of the participating centers.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who have read the information sheet and agreed to participate in the study
Patients affiliated with a social security scheme
Patients aged 18 years or older
New patients to the practice or patients who have not visited the practice in the past six months
Disqualifiers
Patient who has expressed opposition to participating in the study
Age < 18 years
Individual under legal guardianship or curatorship
Pregnant woman
Trial population
The study will be offered to all patients attending a participating investigation center for an oral examination who meet the study's inclusion criteria
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Number of Decayed, Missing, or Filled Teeth in the permanent dentition, measured both clinically and from intraoral scan (IOS) images using the DMFT index
Number of Decayed, Missing, or Filled Teeth in the permanent dentition, measured both clinically and from intraoral scan (IOS) images using the DMFT index
Time frame
at the day of the dental examinationSecondary outcomes
1
Location and extent of carious dental lesions
Location and extent of carious dental lesions: Assessed clinically and from intraoral scan (IOS) images using the simplified International Caries Detection and Assessment System, version 6 (ICDAS-6) score, using a scale from 0 to 6. Higher scores indicate worse outcomes, reflecting increasing severity of carious lesions. Assessed radiographically on panoramic radiographs (OPT) or cone beam CT (CBCT) using a three-level radiographic scale of carious involvement (enamel, initial dentin, deep dentin)"
Time frame
At the day of the dental examination2
Location and extent of dental wear lesions
Location and extent of dental wear lesions: Assessed clinically and from intraoral scan (IOS) images using the BEWE score Assessed radiographically using a three-level scale of dental tissue thickness reduction (enamel thinning, complete enamel surface loss, enamel surface loss with dentin exposure)
Time frame
At the day of the dental examination3
Location, extent, and quality of dental restorations across all detection methods:
Location, extent, and quality of dental restorations across all detection methods: Assessed based on their type, the number of involved surfaces, and their location (using CCAM coding) Assessed using a three-level index: adequate, minor but acceptable defects (to be monitored), major or harmful defects (requiring repair or replacement)
Time frame
At the day of the dental examination4
Periodontal involvement
Periodontal involvement (gingival inflammation, presence of calculus, pockets, recession): Clinically assessed using the Plaque Index Clinically assessed using the CPITN and DPSI indices Assessed from intraoral scan (IOS) images using a 4-level visual index: healthy, inflammation, inflammation with calculus, inflammation with calculus and recession Radiographically assessed based on the location and severity of bone loss visible on panoramic radiographs (OPT) or cone beam CT (CBCT)
Time frame
At the day of the dental examinationSponsors and contacts
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Source ClinicalTrials.gov