Safety and Performance Evaluation of the Calcivis System

Launched by CALCIVIS LTD · May 23, 2016

Keywords

ClinConnect Summary

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 metho...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Patient must be 6 years or older
• • 2. 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
• • 3. 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
• • 4. Patient and / or parent or guardian must be willing and able to give written informed consent
• • 5. Patient and / or parent or guardian must be willing and able to adhere to study schedule
• Exclusion Criteria:
• • 1. Any patient with recent tooth bleaching (within previous two weeks of imaging with the Calcivis System)
• • 2. Any patient having on-going re-mineralization treatment including, but not limited to high concentration prescription fluoride toothpaste
• • 3. Any patient with a fixed orthodontic appliance
• • 4. Any patient currently taking part in a clinical research study, or has taken part in a clinical research study in the previous three months
• • 5. Pregnant and / or nursing mothers