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Trial record 44 of 110 for:    CALCIUM CATION

Caries Lesion Activity in Orthodontic Patients - Calcivis System

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ClinicalTrials.gov Identifier: NCT02771522
Recruitment Status : Completed
First Posted : May 13, 2016
Results First Posted : February 28, 2019
Last Update Posted : February 28, 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: Calcivis System
Enrollment 36
Recruitment Details

Patients were recruited by two Investigators from a routine NHS Orthodontic clinic between 15 February 2017 and 01 May 2018.

Of the 36 patients attending Visit 1, 30 were eligible for Calcivis imaging ( 3 patients were pregnant, 2 patients had appliances on less than 12 months and I patient did not have visible white spot lesions).

Pre-assignment Details  
Arm/Group Title Active Post-othodontic Lesions
Hide Arm/Group Description

Following de-bond, and identification of active post-orthodontic white spot lesions at baseline with the Calcivis imaging system, active teeth were again imaged at 2, 4, 8 and 12 weeks.

Black & white and luminescent images of the teeth were taken. The images of each tooth were 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] 30 [2] 119
Completed [3] 22 [4] 87
Not Completed 8 32
Reason Not Completed
Lost to Follow-up             3            
Withdrawal by Subject             2            
No white spot lesions             3            
[1]
Patients attending baseline visit at de-bond and imaged with Calcivis System
[2]
119 teeth imaged with the Calcivis System from 30 patients
[3]
Patients attending final visit at 8 weeks post de-bond and imaged with Calcivis System
[4]
87 teeth imaged with the Calcivis System fro 22 patients
Arm/Group Title Active Post-othodontic Lesions
Hide Arm/Group Description

Imaging with the Calcivis System: Following de-bond, and identification of active post-orthodontic white spot lesions at baseline with the Calcivis imaging system, each active tooth was again be imaged at 2, 4, 8 and 12 weeks. In order to improve study recruitment, a Protocol Amendment was approved to reduce the overall number of visits to 2, 4 and 8 weeks, however there is data available form all time points.

The images of the teeth are taken immediately before and after application of a small amount of solution. The images of each tooth are 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 30
Hide Baseline Analysis Population Description
Of the 30 patients, 119 teeth were imaged
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
19.9  (6.52)
[1]
Measure Description: All patients who had teeth imaged
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
16
  53.3%
Male
14
  46.7%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 30 participants
30
Number of teeth imaged and deemed active   [1] 
Measure Type: Number
Unit of measure:  Teeth
Number Analyzed 30 participants
73
[1]
Measure Description: Number of teeth imaged by CALCIVIS imaging device deemed active
1.Primary Outcome
Title Presence or Absence of Elevated Luminescence
Hide Description Percentage of active teeth showing luminescence (as measured by Calcivis System imaging) over time
Time Frame 0, 2, 4, 8 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
From 30 participants a total of 119 teeth were imaged at baseline then different numbers of patients attended different follow-up visits
Arm/Group Title Active Post-othodontic Lesions
Hide Arm/Group Description:
Imaging with the Calcivis System - Percentage teeth with luminescence over time
Overall Number of Participants Analyzed 30
Overall Number of Units Analyzed
Type of Units Analyzed: Teeth
119
Measure Type: Number
Unit of Measure: % active teeth with luminescence
Baseline Number Analyzed 119 Teeth
61.7
2 weeks post de-bond Number Analyzed 51 Teeth [1] 
17.3
4 weeks post de-bond Number Analyzed 83 Teeth [2] 
6.0
8 weeks post de-bond Number Analyzed 87 Teeth [3] 
10.2
12 weeks post de-bond Number Analyzed 31 Teeth [4] 
6.3
[1]
13 participants
[2]
21 participants
[3]
22 participants
[4]
8 participants
2.Primary Outcome
Title Presence or Absence of Elevated Luminescence
Hide Description Percentage of active teeth showing luminescence (as measured by Calcivis System imaging) over time, per Investigator
Time Frame 0, 2, 4, 8 and 12 weeks post de-bond
Hide Outcome Measure Data
Hide Analysis Population Description
From a total of 30 participants (28 patients from Investigator 1, and 2 patients from Investigator 2) a total of 119 teeth were imaged at baseline then different numbers of patients attended different follow-up visits
Arm/Group Title Post-orthodontic Lesions
Hide Arm/Group Description:
Imaging with the Calcivis System - Percentage teeth with luminescence over time, per Investigator
Overall Number of Participants Analyzed 30
Overall Number of Units Analyzed
Type of Units Analyzed: Teeth
119
Measure Type: Number
Unit of Measure: % active teeth with luminescence
Site 11 - Baseline Number Analyzed 112 Teeth [1] 
58.9
Site 11 - 2 weeks post de-bond Number Analyzed 44 Teeth [2] 
11.4
Site 11 - 4 weeks post de-bond Number Analyzed 76 Teeth [3] 
2.6
Site 11 - 8 weeks post de-bond Number Analyzed 80 Teeth [4] 
6.3
Site 11 - 12 weeks posar de-bond Number Analyzed 24 Teeth [5] 
8.3
Site 31 - Baseline Number Analyzed 7 Teeth [6] 
100.0
Site 31 - 2 weeks post debond Number Analyzed 7 Teeth [6] 
50.0
Site 31 - 4 weeks posat de-bond Number Analyzed 7 Teeth [6] 
37.5
Site 31 - 8 weeks post de-bond Number Analyzed 7 Teeth [6] 
50.0
Site 31 - 12 weeks post de-bond Number Analyzed 7 Teeth [6] 
0.0
[1]
28 participants
[2]
11 participants
[3]
19 participants
[4]
20 participants
[5]
6 participants
[6]
2 participants
3.Secondary Outcome
Title Number of Non-patient Related Adverse Events With the Calcivis System
Hide Description All adverse events and device deficiencies were collected throughout the study on Adverse Event Forms
Time Frame 0 days, 2, 4, 8 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients imaged with the Calcivis System
Arm/Group Title Active Post-othodontic Lesions
Hide Arm/Group Description:
Imaging with the Calcivis System: Following de-bond, and identification of active post-orthodontic white spot lesions at baseline with the Calcivis System, each active tooth will be again be imaged at 2, 4, 8 and 12 weeks. Black & white and luminescent images of the teeth were taken. The images of each tooth are 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 30
Measure Type: Number
Unit of Measure: Non-patient-related Adverse Events
3
4.Secondary Outcome
Title Patient Experience
Hide Description Completion of Patient Questionnaires after imaging with the Calcivis System
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Patient Questionnaires comprised of two questions and patients were asked to tick the most appropriate response on a three-point scale
Arm/Group Title Post-orthodontic Lesions
Hide Arm/Group Description:
Imaging with the Calcivis System -Following de-bond, and identification of active post-orthodontic white spot lesions at baseline with the Calcivis System, each active tooth will be again be imaged at 2, 4, 8 and 12 weeks. Black & White and luminescent images were taken. he images of each tooth are 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 30
Measure Type: Number
Unit of Measure: participants
Calcivis System experience:good 27
Calcivis System experience:neither good nor bad 3
Calcivis System experience:bad 0
Calcivis System - seeing images:helpful 30
CalcivisSystem-images-neither good nor bad 0
CalcivisSystem - seeing images - bad 0
5.Secondary Outcome
Title Patient Experience
Hide Description Completion of Patient Questionnaires after imaging with the Calcivis System at patient's final visit
Time Frame Final Visit - either 8 or 12 weeks post debond
Hide Outcome Measure Data
Hide Analysis Population Description
Patient Questionnaires comprised two questions and patients asked to tick the most appropriate response on a three-point scale
Arm/Group Title Post-orthodontic Lesions
Hide Arm/Group Description:
Imaging with the Calcivis System -Following de-bond, and identification of active post-orthodontic white spot lesions at baseline with the Calcivis System, each active tooth will be again be imaged at 2, 4, 8 and 12 weeks. Black & White and luminescent images were taken. The images of each tooth are 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 18
Measure Type: Number
Unit of Measure: Participants
Calcivis System experienc: good 16
Calcivis System experience: neither good nor bad 2
Calcivis System experience: bad 0
Calcivis System-seeing images: helpful 18
CalcivisSystem images:neitherhelpfuln 0
Calcivis System - seeing images: unhelpful 0
6.Secondary Outcome
Title User Questionnaires
Hide Description Completion of User Questionnaires after imaging with the Calcivis System
Time Frame Baseline visit
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. They were asked to tick the most appropriate response on a three-point scale e.g. easy, neither easy nor difficult , difficult.
Arm/Group Title Active Post-othodontic Lesions
Hide Arm/Group Description:

Imaging with the Calcivis System -

User Questionnaires comprised four questions and users were asked to tick the most appropriate response on a three-point scale

Overall Number of Participants Analyzed 30
Overall Number of Units Analyzed
Type of Units Analyzed: Questionnaires
30
Measure Type: Number
Unit of Measure: User Questionniares
Calcivis System preparation:easy 21
CalcivisSystempreparation:neithereasynordifficult 9
Calcivis system preparation: difficult 0
Calcivis System use: easy 17
Calcivis System use: neither easy nor difficult 11
calcivis System use: difficult 2
Calcivis System experience: good 24
Calcivis System experience:neither good nor bad 4
Calcivis System experience: bad 2
Understand instructions:easy 19
Understand instructions:neither easy nor difficult 11
Understand instructions: difficult 0
Time Frame 12 weeks post baseline visit
Adverse Event Reporting Description All adverse events and device deficiencies were collected throughout the study on Adverse Event Forms
 
Arm/Group Title Active Post-othodontic Lesions
Hide Arm/Group Description Imaging with the Calcivis System: Following de-bond, and identification of active post-orthodontic white spot lesions at baseline with the Calcivis System, each active tooth will be again be imaged at 2, 4, 8 and 12 weeks. The images of the teeth are taken immediately before and after application of a small amount of disclosing solution. The images of each tooth are 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
Active Post-othodontic Lesions
Affected / at Risk (%)
Total   0/30 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Active Post-othodontic Lesions
Affected / at Risk (%) # Events
Total   0/30 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active Post-othodontic Lesions
Affected / at Risk (%) # Events
Total   3/30 (10.00%)    
Product Issues   
non patient related adverse events  1 [1]  3/30 (10.00%)  3
1
Term from vocabulary, ISO 14155:2011(E)
Indicates events were collected by systematic assessment
[1]
Term from definition in ISO14155:2011 (E) 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 NOT 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: NCT02771522     History of Changes
Other Study ID Numbers: CAL-03-2015
First Submitted: May 12, 2016
First Posted: May 13, 2016
Results First Submitted: February 19, 2019
Results First Posted: February 28, 2019
Last Update Posted: February 28, 2019