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Trial record 41 of 108 for:    CALCIUM CATION

Safety and Performance Evaluation of the Calcivis System

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ClinicalTrials.gov Identifier: NCT02780856
Recruitment Status : Completed
First Posted : May 24, 2016
Results First Posted : February 19, 2019
Last Update Posted : February 19, 2019
Sponsor:
Collaborator:
Medsource UK Ltd.
Information provided by (Responsible Party):
Calcivis Ltd

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Dental Caries
Intervention Device: Imaging with the Calcivis System
Enrollment 110
Recruitment Details

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.

Pre-assignment Details  
Arm/Group Title Sound and Unsound Teeth
Hide Arm/Group Description

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)

Period Title: Overall Study
Number of participants Number of units (Teeth)
Started [1] 110 176
Completed [2] 109 176
Not Completed 1 0
Reason Not Completed
Lost to Follow-up             1            
[1]
Attended Visit 1 when teeth were imaged with the Calcivis System
[2]
Attended Visit 2 - no images taken at this visit
Arm/Group Title Sound and Unsound Teeth
Hide Arm/Group Description

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)

Overall Number of Baseline Participants 110
Overall Number of Units Analyzed
Type of Units Analyzed: Teeth
176
Hide Baseline Analysis Population Description
Eligible patients six years or older were recruited who had one unrestored, accessible free smooth buccal surface on a canine or incisor away from gingival surface identified with no lesion (ICDAS 0) and / or one unrestored, accessible, erupting or erupted molar or pre-molar with a visible lesion (ICDAS 2 or 3) in a plaque stagnation area
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 110 participants
24.3  (12.22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants
Female
61
  55.5%
Male
49
  44.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants
Hispanic or Latino
0
   0.0%
Asian
2
   1.8%
Black
1
   0.9%
White
107
  97.3%
Other
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 110 participants
110
Sound (inactive)and unsound (active) teeth  
Count of Units
Unit of measure:  Teeth
Number Analyzed 176 Teeth
Number of sound teeth
90
  51.1%
Number of unsound teeth
86
  48.9%
1.Primary Outcome
Title Number of Teeth Identified as Sound or Unsound by the Calcivis System That Were in Agreement With the Dentist's Assessment
Hide Description 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
Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Sound Unsound
Hide Arm/Group Description:

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 (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)

Overall Number of Participants Analyzed 90 86
Overall Number of Units Analyzed
Type of Units Analyzed: Teeth
90 86
Count of Units
Unit of Measure: teeth
88
  97.8%
78
  90.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sound
Comments The null and alternative hypothesis for each tooth population was of chance agreement (50%) and was tested against an exact binomial one-sided 97.5% confidence interval
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method exact binomial
Comments An exact binomial test was used and an exact 97.5% Confidence Level using the Clopper-Pearson method was calculated
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Unsound
Comments The null and alternative hypothesis for each tooth population was of chance agreement (50%) and was tested against an exact binomial one-sided 97.5% confidence interval
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method exact binomial
Comments An exact binomial test was used and an exact 97.5% Confidence Level using the Clopper-Pearson method was calculated
2.Primary Outcome
Title Number of Non-patient Related Adverse Events of the Calcivis System
Hide Description Collection of all Adverse Events throughout the duration of the study
Time Frame Day 0 and Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
All patients on whom the Calcivis System has been used
Arm/Group Title Sound and Unsound Teeth
Hide Arm/Group Description:

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 teeth, both black & white and luminescent images were 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 Number of Participants Analyzed 110
Measure Type: Number
Unit of Measure: adverse events
3
3.Secondary Outcome
Title Patient Experience
Hide Description Completion of Patient Questionnaires after imaging with the Calcivis System
Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Sound and Unsound Teeth
Hide Arm/Group Description:

Imaging of sound (ICDAS 0) canines or incisors and unsound (ICDAS 2 or 3) molars or pre-molars 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)

Overall Number of Participants Analyzed 110
Overall Number of Units Analyzed
Type of Units Analyzed: Patient questionnaires
110
Count of Units
Unit of Measure: patient questionnaires
Calcivis System experience: good
93
  84.5%
Calcivis System experience:neither good nor bad
17
  15.5%
Calcivis System experience:bad
0
   0.0%
Image review with Dentist: helpful
106
  96.4%
ImagereviewwithDentist:neitherhelpfulnorunhelpful
4
   3.6%
Image review with Dentist:unhelpful
0
   0.0%
4.Secondary Outcome
Title User Experience
Hide Description Completion of User Questionnaires after imaging with the Calcivis system
Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sound and Unsound Teeth
Hide Arm/Group Description:

Imaging of sound (ICDAS 0) canines or incisors and unsound (ICDAS 2 or 3) molars or pre-molars 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)

Overall Number of Participants Analyzed 110
Overall Number of Units Analyzed
Type of Units Analyzed: User Questionnaires
61
Count of Units
Unit of Measure: User Questionnaires
Calcivis System preparation:easy
49
  80.3%
CalcivisSystempreparation:neithereasynordifficult
9
  14.8%
Calcivis System preparation: difficult
3
   4.9%
Calcivis System use:easy
34
  55.7%
Calcivis System use: neither easy nor difficult
19
  31.1%
Calcivis System use: difficult
8
  13.1%
Calcivis System experience: good
30
  49.2%
Calcivis System experience: neither good nor bad
25
  41.0%
Calcivis System experience: bad
6
   9.8%
Ease of use of IFU: easy
52
  85.2%
Ease of use of IFU: neither easy nor difficult
9
  14.8%
Ease of use of IFU: difficult
0
   0.0%
Time Frame 7 to 14 days
Adverse Event Reporting Description All adverse events and device deficiencies were collected throughout the study on Adverse Event Forms
 
Arm/Group Title Sound and Unsound Teeth
Hide Arm/Group Description

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)

All-Cause Mortality
Sound and Unsound Teeth
Affected / at Risk (%)
Total   0/110 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Sound and Unsound Teeth
Affected / at Risk (%) # Events
Total   0/110 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sound and Unsound Teeth
Affected / at Risk (%) # Events
Total   3/110 (2.73%)    
Product Issues   
Device Deficiency  1 [1]  3/110 (2.73%)  3
1
Term from vocabulary, ISO 14155:2011(E)
Indicates events were collected by systematic assessment
[1]
Device Deficiency - inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Research
Organization: Calcivis Ltd
Phone: + 44 131 658 5152
EMail: mwillins@calcivis.com
Layout table for additonal information
Responsible Party: Calcivis Ltd
ClinicalTrials.gov Identifier: NCT02780856     History of Changes
Other Study ID Numbers: CAL-02-2014
First Submitted: May 12, 2016
First Posted: May 24, 2016
Results First Submitted: July 31, 2018
Results First Posted: February 19, 2019
Last Update Posted: February 19, 2019