Trial Outcomes & Findings for Safety and Performance Evaluation of the Calcivis System (NCT NCT02780856)
NCT ID: NCT02780856
Last Updated: 2019-02-19
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
110 participants
Primary outcome timeframe
Day 0
Results posted on
2019-02-19
Participant Flow
Patients were recruited by 5 Investigators from 4 UK, dental practices between 14 January and 04 May 2017. 110 patients attended Visit 1 and were imaged with the Calcivis System, therefore data from 110 patients are included in the safety and agreement populations.
Unit of analysis: Teeth
Participant milestones
| Measure |
Sound and Unsound Teeth
Sound (ICDAS 0) canines or incisors and unsound (ICDAS 2 or 3) molars or pre-molars - imaging with the Calcivis System
Imaging with the Calcivis System: Following identification of both sound and unsound tooth surfaces, the teeth will be air-dried. Both black \& white and luminescent images will be 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)
|
|---|---|
|
Overall Study
STARTED
|
110 176
|
|
Overall Study
COMPLETED
|
109 176
|
|
Overall Study
NOT COMPLETED
|
1 0
|
Reasons for withdrawal
| Measure |
Sound and Unsound Teeth
Sound (ICDAS 0) canines or incisors and unsound (ICDAS 2 or 3) molars or pre-molars - imaging with the Calcivis System
Imaging with the Calcivis System: Following identification of both sound and unsound tooth surfaces, the teeth will be air-dried. Both black \& white and luminescent images will be 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)
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|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Safety and Performance Evaluation of the Calcivis System
Baseline characteristics by cohort
| Measure |
Sound and Unsound Teeth
n=176 Teeth
Sound (ICDAS 0) canines or incisors and unsound (ICDAS 2 or 3) molars or pre-molars - imaging with the Calcivis System
Imaging with the Calcivis System: Following identification of both sound and unsound tooth surfaces, the teeth will be air-dried and both black \& white and luminescent images 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)
|
|---|---|
|
Age, Continuous
|
24.3 years
STANDARD_DEVIATION 12.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
107 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
110 participants
n=5 Participants
|
|
Sound (inactive)and unsound (active) teeth
Number of sound teeth
|
90 Teeth
n=176 Teeth
|
|
Sound (inactive)and unsound (active) teeth
Number of unsound teeth
|
86 Teeth
n=176 Teeth
|
PRIMARY outcome
Timeframe: Day 0Population: From the 110 patients recruited and imaged with the Calcivis System, 90 provided a sound tooth (ICDAS 0) and 86 provided an unsound tooth (ICDAS 2 or 3) with interpretable images were included in the Primary Agreement Analysis
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
Outcome measures
| Measure |
Sound
n=90 teeth
Sound (ICDAS 0) canines or incisors - imaging with the Calcivis System
Imaging with the Calcivis System: Following identification of both sound and unsound tooth surfaces, the teeth will be air-dried and both black \& white and luminescent images 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)
|
Unsound
n=86 teeth
Unsound (ICDAS 2 or 3) molars or premolars - imaging with the Calcivis System
Following identification of both sound and unsound tooth surfaces, the teeth will be air-dried and both black \& white and luminescent images 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)
|
|---|---|---|
|
Number of Teeth Identified as Sound or Unsound by the Calcivis System That Were in Agreement With the Dentist's Assessment
|
88 teeth
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78 teeth
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PRIMARY outcome
Timeframe: Day 0 and Day 7Population: All patients on whom the Calcivis System has been used
Collection of all Adverse Events throughout the duration of the study
Outcome measures
| Measure |
Sound
n=110 Participants
Sound (ICDAS 0) canines or incisors - imaging with the Calcivis System
Imaging with the Calcivis System: Following identification of both sound and unsound tooth surfaces, the teeth will be air-dried and both black \& white and luminescent images 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)
|
Unsound
Unsound (ICDAS 2 or 3) molars or premolars - imaging with the Calcivis System
Following identification of both sound and unsound tooth surfaces, the teeth will be air-dried and both black \& white and luminescent images 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)
|
|---|---|---|
|
Number of Non-patient Related Adverse Events of the Calcivis System
|
3 adverse events
|
—
|
SECONDARY outcome
Timeframe: Day 0Population: Patient Questionnaires were completed for all 110 patients imaged at Visit 1 and comprised two questions and the patient was asked to tick the most appropriate response on a three-point scale e.g. good, neither good nor bad, bad etc
Completion of Patient Questionnaires after imaging with the Calcivis System
Outcome measures
| Measure |
Sound
n=110 patient questionnaires
Sound (ICDAS 0) canines or incisors - imaging with the Calcivis System
Imaging with the Calcivis System: Following identification of both sound and unsound tooth surfaces, the teeth will be air-dried and both black \& white and luminescent images 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)
|
Unsound
Unsound (ICDAS 2 or 3) molars or premolars - imaging with the Calcivis System
Following identification of both sound and unsound tooth surfaces, the teeth will be air-dried and both black \& white and luminescent images 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)
|
|---|---|---|
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Patient Experience
Calcivis System experience: good
|
93 patient questionnaires
|
—
|
|
Patient Experience
Calcivis System experience:neither good nor bad
|
17 patient questionnaires
|
—
|
|
Patient Experience
Calcivis System experience:bad
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0 patient questionnaires
|
—
|
|
Patient Experience
Image review with Dentist: helpful
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106 patient questionnaires
|
—
|
|
Patient Experience
ImagereviewwithDentist:neitherhelpfulnorunhelpful
|
4 patient questionnaires
|
—
|
|
Patient Experience
Image review with Dentist:unhelpful
|
0 patient questionnaires
|
—
|
SECONDARY outcome
Timeframe: Day 0Population: User Questionnaires were completed by the dentist and nurse at the end of every imaging session about their experiences using the Calcivis System. Imaging sessions could include one or several participants, therefore multiple participants could be accounted for in a single User Questionnaire providing 61 questionnaires covering 110 participants.
Completion of User Questionnaires after imaging with the Calcivis system
Outcome measures
| Measure |
Sound
n=61 User Questionnaires
Sound (ICDAS 0) canines or incisors - imaging with the Calcivis System
Imaging with the Calcivis System: Following identification of both sound and unsound tooth surfaces, the teeth will be air-dried and both black \& white and luminescent images 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)
|
Unsound
Unsound (ICDAS 2 or 3) molars or premolars - imaging with the Calcivis System
Following identification of both sound and unsound tooth surfaces, the teeth will be air-dried and both black \& white and luminescent images 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)
|
|---|---|---|
|
User Experience
Calcivis System experience: bad
|
6 User Questionnaires
|
—
|
|
User Experience
Calcivis System preparation:easy
|
49 User Questionnaires
|
—
|
|
User Experience
CalcivisSystempreparation:neithereasynordifficult
|
9 User Questionnaires
|
—
|
|
User Experience
Calcivis System preparation: difficult
|
3 User Questionnaires
|
—
|
|
User Experience
Calcivis System use:easy
|
34 User Questionnaires
|
—
|
|
User Experience
Calcivis System use: neither easy nor difficult
|
19 User Questionnaires
|
—
|
|
User Experience
Calcivis System use: difficult
|
8 User Questionnaires
|
—
|
|
User Experience
Calcivis System experience: good
|
30 User Questionnaires
|
—
|
|
User Experience
Calcivis System experience: neither good nor bad
|
25 User Questionnaires
|
—
|
|
User Experience
Ease of use of IFU: easy
|
52 User Questionnaires
|
—
|
|
User Experience
Ease of use of IFU: neither easy nor difficult
|
9 User Questionnaires
|
—
|
|
User Experience
Ease of use of IFU: difficult
|
0 User Questionnaires
|
—
|
Adverse Events
Sound and Unsound Teeth
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sound and Unsound Teeth
n=110 participants at risk
Sound (ICDAS 0) canines or incisors and unsound (ICDAS 2 or 3) molars or pre-molars - imaging with the Calcivis System
Imaging with the Calcivis System: Following identification of both sound and unsound tooth surfaces, the teeth will be air-dried and images of each tooth taken immediately before and after application of a small amount of disclosing solution. 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)
|
|---|---|
|
Product Issues
Device Deficiency
|
2.7%
3/110 • Number of events 3 • 7 to 14 days
All adverse events and device deficiencies were collected throughout the study on Adverse Event Forms
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60