Safety and Performance Evaluation of the Calcivis System

Study Overview
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Brief Summary
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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: elevated luminescence and the presence of active caries as determined by the dentists, and absence of luminescence and the determination of a sound tooth surface by the dentists.

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 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.

Official Title
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Clinical Study to Evaluate the Safety and Performance of the Calcivis System for Identifying Active Demineralization on Tooth Surfaces

Conditions
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Dental Caries

Intervention / Treatment
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* Device: Imaging with the Calcivis System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must be 6 years or older Patient must have one unrestored, accessible, free smooth buccal surface on a canine or incisor, away from the gingival surface identified with no visible lesions (coded ICDAS 0) and/or Patient must have one unrestored, accessible, erupting or erupted molar or premolar with a visible lesion identified as (coded ICDAS 2 or 3) in a plaque stagnation area Patient and / or parent or guardian must be willing and able to give written informed consent Patient and / or parent or guardian must be willing and able to adhere to study schedule Exclusion Criteria: Any patient with recent tooth bleaching (within previous two weeks of imaging with the Calcivis System) Any patient having on-going re-mineralization 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: 6 Years
Maximum Age: 100 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sound and unsound teeth<br>Sound (ICDAS 0) canines or incisors and unsound (ICDAS 2 or 3) molars or pre-molars - imaging with the Calcivis System | Device: Imaging with the Calcivis System<br>* 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)<br>* Other names: Calcivis Caries Activity Imaging System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Teeth Identified as Sound or Unsound by the Calcivis System That Were in Agreement With the Dentist's Assessment | Agreement between the dentist's assessment (ICDAS staging) of sound (inactive) and unsound (active) teeth and the visible presence of elevated bioluminescence on the tooth surface using the Calcivis System | Day 0 | 
| Number of Non-patient Related Adverse Events of the Calcivis System | Collection of all Adverse Events 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 | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caries Activity Demineralisation, Demineralisation