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Trial record 20 of 110 for:    CALCIUM CATION

Post-Approval Clinical Study to Evaluate the Calcivis Caries Activity Imaging System

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ClinicalTrials.gov Identifier: NCT02098304
Recruitment Status : Completed
First Posted : March 28, 2014
Results First Posted : April 27, 2016
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Calcivis Ltd

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Dental Caries
Intervention Device: Calcivis Caries Activity Imaging System
Enrollment 42
Recruitment Details A total of 42 Patients were recruited to the study from three UK General Dental Practices by four investigators. All 42 patients attended both Visit 1 and 2 and completed the study. There were no patient withdrawals. Patients were recruited at the three sites over an 8 month period from May 2014 to January 2015.
Pre-assignment Details  
Arm/Group Title Sound and Unsound Molars
Hide Arm/Group Description Imaging of unrestored sound molars (ICDAS 0) and third molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging System
Period Title: Overall Study
Started 42
Completed 42
Not Completed 0
Arm/Group Title Sound and Unsound Molars
Hide Arm/Group Description

Imaging of unrestored sound molars (ICDAS 0) and third Molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging Device

Calcivis Caries Activity Imaging System: Unrestored sound molars and unsound molars imaged with the Calcivis Caries Activity Imaging System

Overall Number of Baseline Participants 42
Hide Baseline Analysis Population Description
Eligible patients were recruited who had at least one unrestored molar identified as sound AND at least one unrestored erupting or erupted third molar coded ICDAS 1,2 or 3.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 42 participants
21.7
(17 to 25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Female
20
  47.6%
Male
22
  52.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants
Caucasian 42
Black African 0
Asian 0
Hispanic 0
Other 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 42 participants
42
1.Primary Outcome
Title Percentage Agreement of Sound/Unsound Teeth Between ICDAS Score and Calcivis System
Hide Description % agreement calculated as no. of teeth where ICDAS assessment & Calcivis System assessment is in agreement/total number of teeth assessed multiplied by 100. Agreement defined as a sound tooth without luminescence & an unsound tooth with luminescence.
Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
All 42 patients recruited are included in the Safety Population, which included any subjects on whom the Calcivis System was used. 31 patients are included in the Agreement Population which included all subjects with at least one tooth with an eligible image. From the 31 patients, 65 teeth were analysed; in some patients multiple teeth were imaged.
Arm/Group Title Sound and Unsound Molars
Hide Arm/Group Description:
Imaging of unrestored sound molars (ICDAS 0) and third molars (ICDAS 1, 2 or 3) with the Calcivis Caries Activity Imaging System
Overall Number of Participants Analyzed 31
Overall Number of Units Analyzed
Type of Units Analyzed: Teeth
65
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage agreement
72.3
(59.8 to 82.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sound and Unsound Molars
Comments The null hypothesis was of chance agreement (50%) and was tested against a two-sided alternative at the 5% level of significance.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Exact binomial test
Comments An exact binomial test was used and an exact 95% Confidence Interval using the Clopper-Pearson method was calculated.
Method of Estimation Estimation Parameter Percentage agreement
Estimated Value 72.3
Confidence Interval (2-Sided) 95%
59.8 to 82.7
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sound and Unsound Molars
Comments The null hypothesis was of chance agreement (Cohen's kappa of 0) and was tested against a two-sided alternative at the 5% level of significance. The study was powered such that 58 teeth (29 subjects), there would be 95% power to reject the null hypothesis of chance agreement (Cohen’s kappa of 0) at the 5% level of significance, given that it was expected to be at least 0.4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Cohen's Kappa
Comments [Not Specified]
Method of Estimation Estimation Parameter Cohen's kappa
Estimated Value 0.45
Confidence Interval (2-Sided) 95%
0.24 to 0.66
Estimation Comments Cohen's kappa is a chance-adjusted measure of agreement. A value of 0 indicates agreement by chance and 1 perfect agreement.
2.Primary Outcome
Title Measure Safety of the Calcivis Caries Imaging System
Hide Description Collection of all adverse events recorded and reported throughout the duration of the study
Time Frame Day 0 and Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Adverse events
Arm/Group Title Sound and Unsound Molars
Hide Arm/Group Description:

Imaging of unrestored sound molars (ICDAS 0) and third Molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging System

Calcivis Caries Activity Imaging System: Unrestored sound molars and third molars imaged with the Calcivis Caries Activity Imaging System

Overall Number of Participants Analyzed 42
Measure Type: Number
Unit of Measure: adverse events
2
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 comprised five questions and the patient was asked to tick the most appropriate response i.e very good, good etc. No numerical values were assigned to the responses
Arm/Group Title Sound and Unsound Molars
Hide Arm/Group Description:
Imaging of unrestored sound molars (ICDAS 0) and third molars (ICDAS 1, 2 or 3) with the Calcivis Caries Activity Imaging System
Overall Number of Participants Analyzed 42
Overall Number of Units Analyzed
Type of Units Analyzed: Patient Questionnaires
42
Measure Type: Number
Unit of Measure: Patient Questionnaires
Overall experience with Calcivis System:very good 30
Overall experience with Calcivis System:good 9
Overall exp. with Calcivis System: not good or bad 2
Overall experience with Calcivis System: bad 1
Overall experience with Calcivis System: very bad 0
Overall exp. with Calcivis system: not recorded 0
Image review with Dentist: very helpful 21
Image review with Dentist:Helpful 16
Image review with Dentist:not helpful or unhelpful 2
Image review with dentist: unhelpful 0
Image review with Dentist: very unhelpful 0
Image review with Dentist: not recorded 3
Any pain from Calcivis System use: none 34
Any pain from Calcivis System use: slight 5
Any pain from Calcivis System Use: moderate 2
Any pain from Calcivis System use: marked 1
Any pain from Calcivis System use: severe 0
Any pain from Calcivis System use: not recorded 0
Any discomfort from Calvisi System use: none 23
Any discomfort from Calcivis System use: minor 17
Any discomfort from Calcivis System use: moderate 1
Any discomfort from Calcivis System use: marked 1
Any discomfort from Calcivis System use:severe 0
Any discomfort with Calcivis System: not recorded 0
Allow Calcivis System use in future: very happy 35
Allow Calcivis System use in furture: probably 7
Allow Calcivis System use in future: not sure 0
Allow Calcivis System use in future: possibly 0
Allow Calcivis System use in future: not allow 0
Allow Calcivis System use in future: not recorded 0
4.Secondary Outcome
Title User Experience
Hide Description Completion of User Questionnaires after imaging with the Calcivis System
Time Frame 0 day
Hide Outcome Measure Data
Hide Analysis Population Description
User Questionnaires comprised nine questions and users were asked to tick the most appropriate response i.e. extremely easy, easy etc. No numerical values were assigned to the responses.
Arm/Group Title Sound and Unsound Molars
Hide Arm/Group Description:

Imaging of unrestored sound molars (ICDAS 0), and third Molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging System

Calcivis Caries Activity Imaging System: Teeth imaged with the Calcivis Caries Activity Imaging System

Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: User questionnaires
Calcivis System software use:extremely easy 4
Calcivis System software use:somewhat easy 10
Calcivis System software use:not easy or difficult 2
Calcivis System software use:somewhat difficult 1
Calcivis System software use:extremely difficult 0
Calcivis System software use:not recorded 0
Disclosing Solution preparation:extremely easy 6
Disclosing Solution preparation:somewhat easy 7
Disclosing Solution prep:not easy or difficult 3
Disclosing Solution prep:somewhat difficult 1
Disclsoing Solution prep.extremely difficult 0
Disclosing Solution prep:not recorded 0
Syringe loading & fit applicator:extremely easy 6
Syringe loading & fit applicator: somewhat easy 9
Syringe load & fit applicator:not easy ordifficult 1
Syringe load & fit applicator:somewhat difficult 1
Syringe load & fit applicator:extremely difficult 0
Syring load & fit applicator:not recorded 0
Device priming: extremely easy 7
Device priming: somewhat easy 10
Device priming: neither easy or difficult 0
Device priming: somewhat difficult 0
Device priming: extremely difficult 0
Device priming: not recorded 0
Ease of use of the device: extremely easy 1
Ease of use of the device:somwehat easy 5
Ease of use of the device: not easy or difficult 1
Ease of use of the device: somewhat difficult 6
Ease of use of the device: extremely difficult 3
Ease of use of the device: not recorded 1
Removal of applicator from device:extremeley easy 12
Removal of appliator from device: somewhat easy 4
Removal of applicator:not easy or difficult 1
Removal of applicator:somewhat difficult 0
Removal of applicator:extremely difficult 0
Removal of applicator: not recorded 0
Ease of cleaning device:extremely easy 15
Ease of cleaning device:somewhat easy 1
Ease of cleaning device:not easy or difficult 0
Ease of cleanig device:somewhat difficult 0
Ease of cleaning device:extremely difficult 0
Ease of cleaning device:not recorded 1
Overall experience with Calcivis System:very good 0
Overall experience with Calcivis System:good 11
Overall exp. with CS:not good or unsatisfactory 2
Overall exp. with CS:unsatisfactory 2
Overall exp.withCalcivis System:veryunsatisfactor 1
Overall exp. with Calcivis System:not recorded 1
Were IFU sufficient to understand:sufficient 14
Were IFU sufficient:somewhat sufficient 1
Were IFU sufficient:not sufficient or insufficient 0
Were IFU sufficient:somewhat insufficient 0
Were IFU sufficient to understand:insufficient 0
Were IFU sufficient to understand:not recorded 2
Time Frame 2 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sound and Unsound Molars
Hide Arm/Group Description

Imaging of unrestored sound molars (ICDAS 0) and third Molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging System

Calcivis Caries Activity Imaging System: Unrestored sound molars and third molars imaged with the Calcivis Caries Activity Imaging System

All-Cause Mortality
Sound and Unsound Molars
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sound and Unsound Molars
Affected / at Risk (%) # Events
Total   0/42 (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 Molars
Affected / at Risk (%) # Events
Total   2/42 (4.76%)    
Skin and subcutaneous tissue disorders   
Minor gum abrasion  [1]  1/42 (2.38%)  1
Bleeding gums  [2]  1/42 (2.38%)  1
Indicates events were collected by systematic assessment
[1]
Minor gum abrasion to oral mucosa surrounding tooth
[2]
Bleeding gums at margin of tooth and gums
All 42 patients recruited to the study are included in the Safety Population, however only 31 patients were included in the Agreement Population as one or more of the images from the Calcivis System were deemed ineligible by independent review.
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.
The Sponsor will not suppress or veto publications however the Sponsor reserves the right to postpone publication and/or communication for a short time to protect intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Charles Ormond
Organization: Clark & Watson Dental Practice
Phone: +44 (0)1324 623445
EMail: charlesormond@nhs.net
Layout table for additonal information
Responsible Party: Calcivis Ltd
ClinicalTrials.gov Identifier: NCT02098304     History of Changes
Other Study ID Numbers: CAL-01-2013
First Submitted: March 20, 2014
First Posted: March 28, 2014
Results First Submitted: February 9, 2016
Results First Posted: April 27, 2016
Last Update Posted: September 29, 2016