Post-Approval Clinical Study to Evaluate the Calcivis Caries Activity Imaging System

Study Overview
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Brief Summary
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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
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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.

Official Title
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Post-Approval Clinical Study to Evaluate the Safety and Performance of the Calcivis Caries Activity Imaging System in a Clinical Setting

Conditions
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Dental Caries

Intervention / Treatment
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* Device: Calcivis Caries Activity Imaging System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must be 16 to 25 years old Patient must have at least one unrestored molar identified as sound according to the ICDAS coding system Patient must have at least one unrestored erupting (in which case occlusal surface must be such that, apart from minimal presence of an operculum over the distal marginal ridge, it is clear of the gingivae (gum)) or erupted third molar with a caries lesion identified, coded 1, 2 or 3 (according to the ICDAS coding system) Patient must be willing and able to give written informed consent Patient must be willing and able to adhere to study schedule Exclusion Criteria: Recent tooth bleaching (within previous two weeks of imaging with the Calcivis System) On-going re-mineralisation treatment including, but not limited to high concentration prescription fluoride toothpaste Any patient with a fixed orthodontic appliance Any patient currently taking part in a clinical research study, or has taken part in a clinical research study in the previous three months Pregnant and / or nursing mothers

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sound and Unsound Molars<br>Imaging of unrestored sound molars (ICDAS 0), and third Molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging System | Device: Calcivis Caries Activity Imaging System<br>* Teeth imaged with the Calcivis Caries Activity Imaging System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Agreement of Sound/Unsound Teeth Between ICDAS Score and Calcivis System | % agreement calculated as no. of teeth where ICDAS assessment & Calcivis System assessment is in agreement/total number of teeth assessed multiplied by 100. Agreement defined as a sound tooth without luminescence & an unsound tooth with luminescence. | Day 0 | 
| Measure Safety of the Calcivis Caries Imaging System | Collection of all adverse events recorded and reported throughout the duration of the study | Day 0 and Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Experience | Completion of Patient Questionnaires after imaging with the Calcivis System | Day 0 | 
| User Experience | Completion of User Questionnaires after imaging with the Calcivis System | 0 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caries, ICDAS, Lesion activity, Demineralisation, Imaging