Post-Approval Clinical Study to Evaluate the Calcivis Caries Activity Imaging System
1 other identifier
interventional
42
1 country
3
Brief Summary
This is a prospective, multi-centre, post-approval clinical study to assess the safety and the performance of the Calcivis Caries Activity Imaging System in aiding the identification of active caries lesions on the occlusal surfaces of human teeth. Following the identification of potential caries lesions by oral examination under ICDAS (International Caries Detection and Assessment System) guidelines, a disclosing solution will be applied which will cause areas of active demineralization (loss of calcium ions) to luminesce - these will be captured with an intra-oral camera to produce mapping images of the tooth surface. For the purposes of this study the presence / absence of luminescence will be used as an indicator of lesion activity / inactivity. The study will be deemed a success if the level of agreement between elevated luminescence with the Calcivis System, and areas of expected lesion activity as rated by the Investigators ICDAS staging, is above 70%, is not due to chance and correlates well with published data on active non-cavitated lesions in molars at various stages of eruption.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2014
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2014
CompletedFirst Posted
Study publicly available on registry
March 28, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedResults Posted
Study results publicly available
April 27, 2016
CompletedSeptember 29, 2016
March 1, 2016
9 months
March 20, 2014
February 9, 2016
August 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage Agreement of Sound/Unsound Teeth Between ICDAS Score and Calcivis System
% 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.
Day 0
Measure Safety of the Calcivis Caries Imaging System
Collection of all adverse events recorded and reported throughout the duration of the study
Day 0 and Day 7
Secondary Outcomes (2)
Patient Experience
Day 0
User Experience
0 day
Study Arms (1)
Sound and Unsound Molars
OTHERImaging of unrestored sound molars (ICDAS 0), and third Molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging System
Interventions
Teeth imaged with the Calcivis Caries Activity Imaging System
Eligibility Criteria
You may qualify if:
- Patient must be 16 to 25 years old
- Patient must have at least one unrestored molar identified as sound according to the ICDAS coding system
- Patient must have at least one unrestored erupting (in which case occlusal surface must be such that, apart from minimal presence of an operculum over the distal marginal ridge, it is clear of the gingivae (gum)) or erupted third molar with a caries lesion identified, coded 1, 2 or 3 (according to the ICDAS coding system)
- Patient must be willing and able to give written informed consent
- Patient must be willing and able to adhere to study schedule
You may not qualify if:
- Recent tooth bleaching (within previous two weeks of imaging with the Calcivis System)
- On-going re-mineralisation treatment including, but not limited to high concentration prescription fluoride toothpaste
- Any patient with a fixed orthodontic appliance
- Any patient currently taking part in a clinical research study, or has taken part in a clinical research study in the previous three months
- Pregnant and / or nursing mothers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Calcivis Ltdlead
Study Sites (3)
Bathgate Smile Centre
Bathgate, EH482SS, United Kingdom
Downie, Haper and Shanks Dental Practice
Edinburgh, EH17 8HP, United Kingdom
Clark and Watson Dental Practice
Falkirk, FK1 1JJ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Dr Charles Ormond
- Organization
- Clark & Watson Dental Practice
Study Officials
- PRINCIPAL INVESTIGATOR
Charles Ormond, BDS,MGDS,FDS
Clark and Watson Dental Practice
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2014
First Posted
March 28, 2014
Study Start
May 1, 2014
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
September 29, 2016
Results First Posted
April 27, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will share
Final Clinical Study Report issued