N/A
N=42
Post-Approval Clinical Study to Evaluate the Calcivis Caries Activity Imaging System
Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT02098304 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Percentage Agreement of Sound/Unsound Teeth Between ICDAS Score and Calcivis System — 72.3 percentage agreement — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Calcivis Caries Activity Imaging System (Device)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- Calcivis Ltd
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Agreement of Sound/Unsound Teeth Between ICDAS Score and Calcivis System |
72.3 | <0.001 sig |
| PRIMARY Measure Safety of the Calcivis Caries Imaging System |
2 | — |
| SECONDARY Patient Experience |
30; 9; 2; 1; 0; 0 | — |
| SECONDARY User Experience |
4; 10; 2; 1; 0; 0 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02098304). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.