Caries Lesion Activity in Orthodontic Patients - Calcivis System
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This is a prospective, single-centre clinical study to monitor caries lesion activity in
      orthodontic patients with the Calcivis System over a 12 week period. Dentists will identify
      patients who have had dental appliances in place for a minimum of 12 months and have visible
      white spot lesions on the anterior surfaces of incisors and / or canines at de-bond.
      Following de-bond, images of the tooth surface will be taken with the Calcivis System.
      Presence or absence of elevated luminescence on the images will indicate activity /
      inactivity. Only patients with at least one tooth identified as active with the Calcivis
      System will continue in the study and be followed up at 2, 4, 8 and 12 weeks de-bond. Images
      of the active teeth will be taken with the Calcivis System as before, at each follow-up
      visit.

      The percentage of teeth showing luminescence using the Calcivis System will be calculated and
      summarised for all subjects for each post-baseline visit, and additionally by Investigator.
      This will then be summarised over all subjects for each post-baseline visit.
    

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 requires 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.

      It is generally recognised and reported in the dental literature that patients undergoing
      orthodontic treatment with fixed appliances find it difficult to maintain meticulous oral
      hygiene and that, as a result, plaque accumulates adjacent to the orthodontic brackets (which
      are usually placed on the buccal, Free Smooth, surfaces of teeth, which are readily visible)
      holding the metal wires which are involved in moving the teeth - thus white spot lesions
      commonly develop at these sites of plaque stagnation. These lesions are, de facto, actively
      developing during orthodontic treatment, thus represent 'active lesions'. Once the wires and
      brackets are removed post-treatment, normal oral hygiene can be resumed, the plaque/biofilm
      over these lesions is readily removed and they become arrested, i.e. the demineralisation
      process ceases. Thus during a short period of time - a matter of weeks - there is usually a
      transition from active to inactive status for these 'orthodontically-induced' white spot
      lesions. By assessing and monitoring these lesions, using the Calcivis device, at relatively
      short intervals during this period of lesion status transition immediately post orthodontic
      treatment it would be possible to monitor the reduction in the demineralisation process as
      these lesions arrest.

      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, single-centre clinical study has been designed to assess the use of the
      Calcivis System for monitoring the activity levels of post-orthodontic treatment white spot
      lesions over time. The Dentist will share the images with the patient

      The device under evaluation comprises a hand-held customized intra-oral camera which takes
      both black & white and luminescent images of a lesion on a tooth surface while simultaneously
      applying a photoprotein solution. The photo-protein detects free calcium ions on the tooth
      surface and produces a light signal if the caries lesion is active.

      For the study, patients attending routine Orthodontic appointments to have their appliances
      checked, and who are identified by the Investigator as meeting the Inclusion and Exclusion
      criteria, and are ready for de-bond, 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 asked to attend for
      five Study Visits - de-bond (baseline), 2, 4, 8 and 12 weeks. 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, oral hygiene and orthodontic history
      data will be collected.

      The orthodontist 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 free smooth tooth surfaces will again
      be air dried before taking the black & white and luminescent images with the Calcivis System.
      After imaging is completed, patients rinse out with tap water. Adverse event will be
      collected throughout. The dentist will then share the 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.

      Only patients who have 'active' lesions on de-bond, as confirmed with the Calcivis System at
      the baseline visit, will be followed up in this study. If all lesions are assessed as
      'inactive', the patient will be withdrawn from the study

      Eligible patients will return for Study Visits at 2, 4, 8 and 12 weeks post-de-bond. At each
      of these visits, following a reference photograph of the teeth, each tooth which was "active"
      at Study Visit 1 will again be imaged with the Calcivis System as described above and the
      images shared with the patient. In addition, both Patient and User Questionnaires will be
      completed at the final Study Visit at 12 weeks.
    

Intervention name(s): Calcivis System
Intervention type(s): Device
Intervention description(s): Following de-bond, and identification of active post-orthodontic white spot lesions at baseline with the Calcivis System, each active tooth will be again be imaged at 2, 4, 8 and 12 weeks. Both black & white and luminescent images images of the teeth are taken. The images of each tooth are 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, Acitivity, Demineralsiation