Post-Approval Clinical Study to Evaluate the Calcivis Caries Activity Imaging System
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This is a prospective, multi-centre, post-approval clinical study to assess the safety and
      the performance of the Calcivis Caries Activity Imaging System in aiding the identification
      of active caries lesions on the occlusal surfaces of human teeth. Following the
      identification of potential caries lesions by oral examination under ICDAS (International
      Caries Detection and Assessment System) guidelines, a disclosing solution will be applied
      which will cause areas of active demineralization (loss of calcium ions) to luminesce - these
      will be captured with an intra-oral camera to produce mapping images of the tooth surface.
      For the purposes of this study the presence / absence of luminescence will be used as an
      indicator of lesion activity / inactivity.

      The study will be deemed a success if the level of agreement between elevated luminescence
      with the Calcivis System, and areas of expected lesion activity as rated by the Investigators
      ICDAS staging, is above 70%, is not due to chance and correlates well with published data on
      active non-cavitated lesions in molars at various stages of eruption.
    

Detailed description: 
      Dental caries (tooth decay) is a significant clinical and public health problem. The
      development of caries lesions involves a net mineral loss of dental tissue, which can lead to
      progressive loss of tooth structure surface, associated pain and disease. Detecting,
      assessing, diagnosing and treating such lesions are core activities in dentistry. Currently
      the main detection and diagnosis aids are visual inspection and the use of a probe, together
      with X-ray images. Determination of the activity status of a lesion (how likely it is to
      progress) is required to assess treatment needs. Currently methods are problematic and
      involve the clinician's subjective assessment and / or monitoring lesion progression over a
      number of visits.

      Therefore, this prospective, multi-centre, post-approval clinical study has been designed to
      assess the safety and performance of the Calcivis Caries Activity Imaging System in a
      clinical setting.

      The device under evaluation - the Calcivis Caries Activity Imaging System comprises a
      hand-held specialised intra-oral camera which takes images of the lesion on the tooth surface
      immediately before and after application of a disclosing solution which contains a
      photoprotein. This photoprotein will detect free calcium ions on the tooth surface and
      produces a visible light signal if the caries lesion is active.

      Patients attending routine dental appointments and / or patients on the dental practice
      register, who are identified by the Investigator as meeting all the study inclusion and
      exclusion criteria will be approached to discuss their possible participation in the study.
      Patients will be given a Patient Information Sheet to read and time to consider their
      participation. If they agree to participate, they will be asked to attend for two study
      visits, one week apart. Written informed consent will be taken before any study procedures
      are conducted.

      At Study Visit 1, pre-imaging demographics and oral hygiene information will be collected.
      All occlusal surfaces of the teeth (12 possible molars and pre-molars) will be cleaned by the
      Dentist, by brushing with dental paste and rinsing with tap water and using a 3-in-1 air /
      water spray, according to a Tooth Cleaning Protocol. The Dentist will then perform an oral
      examination identifying and noting the ICDAS score of each tooth to be imaged with the
      Calcivis System. Colour photographs will be taken with a standard intra-oral camera of each
      selected molar and surrounding mucosa. Each tooth selected for imaging will be air dried for
      5 seconds immediately before application of the disclosing solution and imaging. Images of
      one sound tooth and one unrestored erupted, or erupting third molar with an ICDAS score of
      1,2 or 3 will be imaged. An additional two teeth may be imaged (remaining erupted / erupting
      third molar and / or any other molar with an ICDAS score of 1,2 or 3), up to a maximum of
      four teeth. Immediately after imaging has been completed, patients rinse out with tap water
      and a second colour photograph will be taken with a standard intra-oral camera of each
      selected molar and surrounding mucosa. Any adverse events will be recorded.

      Post-imaging Questionnaires will be completed by all patients at the end of Study Visit 1,
      and User Questionnaires will be completed at the end of each Study Visit day.

      Patients will return after one week for Study Visit 2. At this visit, a final oral
      examination will be conducted and colour will be taken with a standard intra-oral camera of
      each selected molar and surrounding mucosa. Any adverse events observed or volunteered by the
      patient will be recorded.

      At the end of either Study Visit 1 or 2, the Dentist may share the images of the teeth imaged
      with the Calcivis System with the patient.
    

Intervention name(s): Calcivis Caries Activity Imaging System
Intervention type(s): Device
Intervention description(s): Teeth imaged with the Calcivis Caries Activity Imaging System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Caries; ICDAS; Lesion activity; Demineralisation; Imaging