Safety and Performance Evaluation of the Calcivis System
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This is a prospective, multi-centre clinical study to evaluate the safety and performance of
      the Calcivis Caries Activity Imaging System. Dentists will identify tooth surfaces as either
      sound (inactive) or unsound (active caries lesion present) according to ICDAS staging
      (International Caries Detection and Assessment System). Images of the tooth surface will be
      taken with the Calcivis System immediately before and after application of a disclosing
      solution containing a bioluminescent protein. Presence or absence of elevated luminescence on
      the images will indicate activity / inactivity of the presence or absence of active
      demineralisation on the tooth surfaces.

      The study will be deemed a success if there is 70% agreement and above between:

        1. elevated luminescence and the presence of active caries as determined by the dentists,
           and

        2. absence of luminescence and the determination of a sound tooth surface by the dentists.
    

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 and associated pain and disease. Detecting, assessing,
      diagnosis and treating such lesions are core activities in dentistry. Currently the main
      detection and diagnosis aids are visual inspection and the used 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
      clinicians' subjective assessment and / or monitoring of lesions progression over a number of
      visits.

      A previous clinical study on the prototype of the Calcivis System has been conducted. The
      results concluded that the Calcivis System was safe for use and the level of agreement
      between elevated luminescence and areas of expected activity was above 70% and not due to
      chance (NCT02098304).

      This prospective, multi-centre clinical study has been designed to assess the safety and
      performance of the Calcivis System. The device under evaluation comprises a hand-held
      customized intra-oral camera which takes images of a lesion on a tooth surface immediately
      before and after application of a disclosing solution which contains a bioluminescent
      photo-protein. The photo-protein detects free calcium ions on the tooth surface and produces
      a light signal if the caries lesion is active.

      For the clinical study, patients identified by the Investigator from those attending routine
      dental appointments, who meet all the 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 in the study. If they are
      happy to participate they will attend for two Study Visits, 7 to 14 days apart. Written
      informed consent will be taken before any study procedures are conducted. As children under
      the age of 16 are included in this study, parent / guardian consent will be taken where
      appropriate.

      At study Visit 1, demographics, relevant medications and oral hygiene data will be collected.
      The dentist will carry out an oral examination and the tooth / teeth identified as per
      inclusion / exclusion criteria, will be cleaned with prophy paste, rinsed with tap water and
      a 3-in-1 air / water spray before being air dried and staged as per ICDAS coding. Reference
      intra-oral photographs will be taken of each tooth. The tooth / teeth surfaces will again be
      air dried before imaging with the Calcivis System, immediately before and after application
      of the disclosing solution. A maximum of one sound (unrestored, accessible, free smooth
      surface of a canine or incisor, away from the gingival margin with no visible caries lesion)
      and one unsound (erupting or erupted molar or premolar with a visible lesion deemed to be
      active, in a plaque stagnation area) tooth will be imaged per patient. after imaging is
      completed, patients rinse out with tap water. Adverse events will be collected throughout.
      The dentist will then share the Calcivis images of the teeth with the patient. Post imaging
      questionnaires will be completed by each patient at the end of Study Visit 1 and user
      questionnaires completed by the dental team at the end of each Study Visit 1 day.

      Patients will return for (Study Visit 2), 7 to 14 days after Visit 1, when a final oral
      examination will take place. Any adverse events observed or volunteered by the patient will
      be recorded.

      The study images will be independently reviewed by another dentist, for agreement between
      expected lesion activity / inactive teeth and the Calcivis System.
    

Intervention name(s): Imaging with the Calcivis System
Intervention type(s): Device
Intervention description(s): Following identification of both sound and unsound tooth surfaces, the teeth will be air-dried and a black & white and luminescent image of each tooth taken. The images of each tooth will be overlaid and a resulting demineralization map of the tooth produced, indicating areas of elevated bioluminescence corresponding to free calcium ions on the surface of the tooth (active caries)
Other intervention name(s): Calcivis Caries Activity Imaging System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Caries Activity Demineralisation; Demineralisation