Trial Outcomes & Findings for Post-Approval Clinical Study to Evaluate the Calcivis Caries Activity Imaging System (NCT NCT02098304)
NCT ID: NCT02098304
Last Updated: 2016-09-29
Results Overview
% 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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
Day 0
Results posted on
2016-09-29
Participant Flow
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.
Participant milestones
| Measure |
Sound and Unsound Molars
Imaging of unrestored sound molars (ICDAS 0) and third molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging System
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post-Approval Clinical Study to Evaluate the Calcivis Caries Activity Imaging System
Baseline characteristics by cohort
| Measure |
Sound and Unsound Molars
n=42 Participants
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
|
|---|---|
|
Age, Continuous
|
21.7 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
42 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black African
|
0 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=99 Participants
|
|
Region of Enrollment
United Kingdom
|
42 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 0Population: 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.
% 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.
Outcome measures
| Measure |
Sound and Unsound Molars
n=65 teeth
Imaging of unrestored sound molars (ICDAS 0) and third molars (ICDAS 1, 2 or 3) with the Calcivis Caries Activity Imaging System
|
|---|---|
|
Percentage Agreement of Sound/Unsound Teeth Between ICDAS Score and Calcivis System
|
72.3 percentage agreement
Interval 59.8 to 82.7
|
PRIMARY outcome
Timeframe: Day 0 and Day 7Population: Adverse events
Collection of all adverse events recorded and reported throughout the duration of the study
Outcome measures
| Measure |
Sound and Unsound Molars
n=42 Participants
Imaging of unrestored sound molars (ICDAS 0) and third molars (ICDAS 1, 2 or 3) with the Calcivis Caries Activity Imaging System
|
|---|---|
|
Measure Safety of the Calcivis Caries Imaging System
|
2 adverse events
|
SECONDARY outcome
Timeframe: Day 0Population: 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
Completion of Patient Questionnaires after imaging with the Calcivis System
Outcome measures
| Measure |
Sound and Unsound Molars
n=42 Patient Questionnaires
Imaging of unrestored sound molars (ICDAS 0) and third molars (ICDAS 1, 2 or 3) with the Calcivis Caries Activity Imaging System
|
|---|---|
|
Patient Experience
Overall experience with Calcivis System:very good
|
30 Patient Questionnaires
|
|
Patient Experience
Overall experience with Calcivis System:good
|
9 Patient Questionnaires
|
|
Patient Experience
Overall exp. with Calcivis System: not good or bad
|
2 Patient Questionnaires
|
|
Patient Experience
Overall experience with Calcivis System: bad
|
1 Patient Questionnaires
|
|
Patient Experience
Overall experience with Calcivis System: very bad
|
0 Patient Questionnaires
|
|
Patient Experience
Overall exp. with Calcivis system: not recorded
|
0 Patient Questionnaires
|
|
Patient Experience
Image review with Dentist: very helpful
|
21 Patient Questionnaires
|
|
Patient Experience
Image review with Dentist:Helpful
|
16 Patient Questionnaires
|
|
Patient Experience
Image review with Dentist:not helpful or unhelpful
|
2 Patient Questionnaires
|
|
Patient Experience
Image review with dentist: unhelpful
|
0 Patient Questionnaires
|
|
Patient Experience
Image review with Dentist: very unhelpful
|
0 Patient Questionnaires
|
|
Patient Experience
Image review with Dentist: not recorded
|
3 Patient Questionnaires
|
|
Patient Experience
Any pain from Calcivis System use: none
|
34 Patient Questionnaires
|
|
Patient Experience
Any pain from Calcivis System use: slight
|
5 Patient Questionnaires
|
|
Patient Experience
Any pain from Calcivis System Use: moderate
|
2 Patient Questionnaires
|
|
Patient Experience
Any pain from Calcivis System use: marked
|
1 Patient Questionnaires
|
|
Patient Experience
Any pain from Calcivis System use: severe
|
0 Patient Questionnaires
|
|
Patient Experience
Any pain from Calcivis System use: not recorded
|
0 Patient Questionnaires
|
|
Patient Experience
Any discomfort from Calvisi System use: none
|
23 Patient Questionnaires
|
|
Patient Experience
Any discomfort from Calcivis System use: minor
|
17 Patient Questionnaires
|
|
Patient Experience
Any discomfort from Calcivis System use: moderate
|
1 Patient Questionnaires
|
|
Patient Experience
Any discomfort from Calcivis System use: marked
|
1 Patient Questionnaires
|
|
Patient Experience
Any discomfort from Calcivis System use:severe
|
0 Patient Questionnaires
|
|
Patient Experience
Any discomfort with Calcivis System: not recorded
|
0 Patient Questionnaires
|
|
Patient Experience
Allow Calcivis System use in future: very happy
|
35 Patient Questionnaires
|
|
Patient Experience
Allow Calcivis System use in furture: probably
|
7 Patient Questionnaires
|
|
Patient Experience
Allow Calcivis System use in future: not sure
|
0 Patient Questionnaires
|
|
Patient Experience
Allow Calcivis System use in future: possibly
|
0 Patient Questionnaires
|
|
Patient Experience
Allow Calcivis System use in future: not allow
|
0 Patient Questionnaires
|
|
Patient Experience
Allow Calcivis System use in future: not recorded
|
0 Patient Questionnaires
|
SECONDARY outcome
Timeframe: 0 dayPopulation: 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.
Completion of User Questionnaires after imaging with the Calcivis System
Outcome measures
| Measure |
Sound and Unsound Molars
n=17 Participants
Imaging of unrestored sound molars (ICDAS 0) and third molars (ICDAS 1, 2 or 3) with the Calcivis Caries Activity Imaging System
|
|---|---|
|
User Experience
Overall exp.withCalcivis System:veryunsatisfactor
|
1 User questionnaires
|
|
User Experience
Overall exp. with Calcivis System:not recorded
|
1 User questionnaires
|
|
User Experience
Were IFU sufficient to understand:sufficient
|
14 User questionnaires
|
|
User Experience
Calcivis System software use:extremely easy
|
4 User questionnaires
|
|
User Experience
Calcivis System software use:somewhat easy
|
10 User questionnaires
|
|
User Experience
Calcivis System software use:not easy or difficult
|
2 User questionnaires
|
|
User Experience
Calcivis System software use:somewhat difficult
|
1 User questionnaires
|
|
User Experience
Calcivis System software use:extremely difficult
|
0 User questionnaires
|
|
User Experience
Calcivis System software use:not recorded
|
0 User questionnaires
|
|
User Experience
Disclosing Solution preparation:extremely easy
|
6 User questionnaires
|
|
User Experience
Disclosing Solution preparation:somewhat easy
|
7 User questionnaires
|
|
User Experience
Disclosing Solution prep:not easy or difficult
|
3 User questionnaires
|
|
User Experience
Disclosing Solution prep:somewhat difficult
|
1 User questionnaires
|
|
User Experience
Disclsoing Solution prep.extremely difficult
|
0 User questionnaires
|
|
User Experience
Disclosing Solution prep:not recorded
|
0 User questionnaires
|
|
User Experience
Syringe loading & fit applicator:extremely easy
|
6 User questionnaires
|
|
User Experience
Syringe loading & fit applicator: somewhat easy
|
9 User questionnaires
|
|
User Experience
Syringe load & fit applicator:not easy ordifficult
|
1 User questionnaires
|
|
User Experience
Syringe load & fit applicator:somewhat difficult
|
1 User questionnaires
|
|
User Experience
Syringe load & fit applicator:extremely difficult
|
0 User questionnaires
|
|
User Experience
Syring load & fit applicator:not recorded
|
0 User questionnaires
|
|
User Experience
Device priming: extremely easy
|
7 User questionnaires
|
|
User Experience
Device priming: somewhat easy
|
10 User questionnaires
|
|
User Experience
Device priming: neither easy or difficult
|
0 User questionnaires
|
|
User Experience
Device priming: somewhat difficult
|
0 User questionnaires
|
|
User Experience
Device priming: extremely difficult
|
0 User questionnaires
|
|
User Experience
Device priming: not recorded
|
0 User questionnaires
|
|
User Experience
Ease of use of the device: extremely easy
|
1 User questionnaires
|
|
User Experience
Ease of use of the device:somwehat easy
|
5 User questionnaires
|
|
User Experience
Ease of use of the device: not easy or difficult
|
1 User questionnaires
|
|
User Experience
Ease of use of the device: somewhat difficult
|
6 User questionnaires
|
|
User Experience
Ease of use of the device: extremely difficult
|
3 User questionnaires
|
|
User Experience
Ease of use of the device: not recorded
|
1 User questionnaires
|
|
User Experience
Removal of applicator from device:extremeley easy
|
12 User questionnaires
|
|
User Experience
Removal of appliator from device: somewhat easy
|
4 User questionnaires
|
|
User Experience
Removal of applicator:not easy or difficult
|
1 User questionnaires
|
|
User Experience
Removal of applicator:somewhat difficult
|
0 User questionnaires
|
|
User Experience
Removal of applicator:extremely difficult
|
0 User questionnaires
|
|
User Experience
Removal of applicator: not recorded
|
0 User questionnaires
|
|
User Experience
Ease of cleaning device:extremely easy
|
15 User questionnaires
|
|
User Experience
Ease of cleaning device:somewhat easy
|
1 User questionnaires
|
|
User Experience
Ease of cleaning device:not easy or difficult
|
0 User questionnaires
|
|
User Experience
Ease of cleanig device:somewhat difficult
|
0 User questionnaires
|
|
User Experience
Ease of cleaning device:extremely difficult
|
0 User questionnaires
|
|
User Experience
Ease of cleaning device:not recorded
|
1 User questionnaires
|
|
User Experience
Overall experience with Calcivis System:very good
|
0 User questionnaires
|
|
User Experience
Overall experience with Calcivis System:good
|
11 User questionnaires
|
|
User Experience
Overall exp. with CS:not good or unsatisfactory
|
2 User questionnaires
|
|
User Experience
Overall exp. with CS:unsatisfactory
|
2 User questionnaires
|
|
User Experience
Were IFU sufficient:somewhat sufficient
|
1 User questionnaires
|
|
User Experience
Were IFU sufficient:not sufficient or insufficient
|
0 User questionnaires
|
|
User Experience
Were IFU sufficient:somewhat insufficient
|
0 User questionnaires
|
|
User Experience
Were IFU sufficient to understand:insufficient
|
0 User questionnaires
|
|
User Experience
Were IFU sufficient to understand:not recorded
|
2 User questionnaires
|
Adverse Events
Sound and Unsound Molars
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sound and Unsound Molars
n=42 participants at risk
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
|
|---|---|
|
Skin and subcutaneous tissue disorders
Minor gum abrasion
|
2.4%
1/42 • Number of events 1 • 2 weeks
|
|
Skin and subcutaneous tissue disorders
Bleeding gums
|
2.4%
1/42 • Number of events 1 • 2 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER