N/A
N=110
Safety and Performance Evaluation of the Calcivis System
Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT02780856 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Number of Teeth Identified as Sound or Unsound by the Calcivis System That Were in Agreement With the Dentist's Assessment — 88; 78 teeth — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Imaging with the Calcivis System (Device)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- Calcivis Ltd
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Teeth Identified as Sound or Unsound by the Calcivis System That Were in Agreement With the Dentist's Assessment |
88; 78 | <0.0001 sig |
| PRIMARY Number of Non-patient Related Adverse Events of the Calcivis System |
3 | — |
| SECONDARY Patient Experience |
93; 17; 0; 106; 4; 0 | — |
| SECONDARY User Experience |
49; 9; 3; 34; 19; 8 | — |
Summary
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:
1. elevated luminescence and the presence of active caries as determined by the dentists, and
2. absence of luminescence and the determination of a sound tooth surface by the dentists.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02780856). 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.