Dental CariesNCT02098304
Post-Approval Clinical Study to Evaluate the Calcivis Caries Activity Imaging System
A study testing Calcivis Caries Activity Imaging System in people with Dental Caries, run by Calcivis Ltd at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Calcivis Caries Activity Imaging System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- May 2014to Feb 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Bathgate Smile Centre
Bathgate, EH482SS
Downie, Haper and Shanks Dental Practice
Edinburgh, EH17 8HP
Clark and Watson Dental Practice
Falkirk, FK1 1JJ
About this study
Official title: Post-Approval Clinical Study to Evaluate the Safety and Performance of the Calcivis Caries Activity Imaging System in a Clinical Setting
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.
Read the detailed description
Dental caries (tooth decay) is a significant clinical and public health problem. The development of caries lesions involves a net mineral loss of dental tissue, which can lead to progressive loss of tooth structure surface, associated pain and disease. Detecting, assessing, diagnosing and treating such lesions are core activities in dentistry. Currently the main detection and diagnosis aids are visual inspection and the use of a probe, together with X-ray images. Determination of the activity status of a lesion (how likely it is to progress) is required to assess treatment needs. Currently methods are problematic and involve the clinician's subjective assessment and / or monitoring lesion progression over a number of visits.
Therefore, this prospective, multi-centre, post-approval clinical study has been designed to assess the safety and performance of the Calcivis Caries Activity Imaging System in a clinical setting.
The device under evaluation - the Calcivis Caries Activity Imaging System comprises a hand-held specialised intra-oral camera which takes images of the lesion on the tooth surface immediately before and after application of a disclosing solution which contains a photoprotein. This photoprotein will detect free calcium ions on the tooth surface and produces a visible light signal if the caries lesion is active.
Patients attending routine dental appointments and / or patients on the dental practice register, who are identified by the Investigator as meeting all the study inclusion and exclusion criteria will be approached to discuss their possible participation in the study. Patients will be given a Patient Information Sheet to read and time to consider their participation. If they agree to participate, they will be asked to attend for two study visits, one week apart. Written informed consent will be taken before any study procedures are conducted.
At Study Visit 1, pre-imaging demographics and oral hygiene information will be collected. All occlusal surfaces of the teeth (12 possible molars and pre-molars) will be cleaned by the Dentist, by brushing with dental paste and rinsing with tap water and using a 3-in-1 air / water spray, according to a Tooth Cleaning Protocol. The Dentist will then perform an oral examination identifying and noting the ICDAS score of each tooth to be imaged with the Calcivis System. Colour photographs will be taken with a standard intra-oral camera of each selected molar and surrounding mucosa. Each tooth selected for imaging will be air dried for 5 seconds immediately before application of the disclosing solution and imaging. Images of one sound tooth and one unrestored erupted, or erupting third molar with an ICDAS score of 1,2 or 3 will be imaged. An additional two teeth may be imaged (remaining erupted / erupting third molar and / or any other molar with an ICDAS score of 1,2 or 3), up to a maximum of four teeth. Immediately after imaging has been completed, patients rinse out with tap water and a second colour photograph will be taken with a standard intra-oral camera of each selected molar and surrounding mucosa. Any adverse events will be recorded.
Post-imaging Questionnaires will be completed by all patients at the end of Study Visit 1, and User Questionnaires will be completed at the end of each Study Visit day.
Patients will return after one week for Study Visit 2. At this visit, a final oral examination will be conducted and colour will be taken with a standard intra-oral camera of each selected molar and surrounding mucosa. Any adverse events observed or volunteered by the patient will be recorded.
At the end of either Study Visit 1 or 2, the Dentist may share the images of the teeth imaged with the Calcivis System with the patient.
- Conditions
- Dental Caries
- Being tested
- Calcivis Caries Activity Imaging System
- Keywords
- Caries, ICDAS, Lesion activity, Demineralisation, Imaging
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcivis Caries Activity Imaging SystemDevice
Teeth imaged with the Calcivis Caries Activity Imaging System
| Study group | Role | What they receive |
|---|---|---|
| Sound and Unsound Molars | Other | Imaging of unrestored sound molars (ICDAS 0), and third Molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging System Receives: Device: Calcivis Caries Activity Imaging System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Measure Safety of the Calcivis Caries Imaging System
Collection of all adverse events recorded and reported throughout the duration of the study
Measured: Day 0 and Day 7
Secondary outcomes (2)
Patient Experience
Completion of Patient Questionnaires after imaging with the Calcivis System
Measured: Day 0
User Experience
Completion of User Questionnaires after imaging with the Calcivis System
Measured: 0 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calcivis Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles Ormond, BDS,MGDS,FDS, Principal investigator, Clark and Watson Dental Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098304
- Sponsor's protocol ID
- CAL-01-2013
- Status last verified
- Mar 2016
- First submitted
- 20 Mar 2014
- Last updated
- 29 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Final Clinical Study Report issued
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Approval Clinical Study to Evaluate the Safety and Performance of the Calcivis Caries Activity Imaging System in a Clinical Setting
- ClinicalTrials.gov ID
- NCT02098304
- Acronym / sponsor ID
- CAL-01-2013
- Conditions
- Dental Caries
- Keywords
- Caries, ICDAS, Lesion activity, Demineralisation, Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Calcivis LtdIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 28 Mar 2014 (estimated)
- Results
- Posted 27 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Dental caries (tooth decay) is a significant clinical and public health problem. The development of caries lesions involves a net mineral loss of dental tissue, which can lead to progressive loss of tooth structure surface, associated pain and disease. Detecting, assessing, diagnosing and treating such lesions are core activities in dentistry. Currently the main detection and diagnosis aids are visual inspection and the use of a probe, together with X-ray images. Determination of the activity status of a lesion (how likely it is to progress) is required to assess treatment needs. Currently methods are problematic and involve the clinician's subjective assessment and / or monitoring lesion progression over a number of visits.
Therefore, this prospective, multi-centre, post-approval clinical study has been designed to assess the safety and performance of the Calcivis Caries Activity Imaging System in a clinical setting.
The device under evaluation - the Calcivis Caries Activity Imaging System comprises a hand-held specialised intra-oral camera which takes images of the lesion on the tooth surface immediately before and after application of a disclosing solution which contains a photoprotein. This photoprotein will detect free calcium ions on the tooth surface and produces a visible light signal if the caries lesion is active.
Patients attending routine dental appointments and / or patients on the dental practice register, who are identified by the Investigator as meeting all the study inclusion and exclusion criteria will be approached to discuss their possible participation in the study. Patients will be given a Patient Information Sheet to read and time to consider their participation. If they agree to participate, they will be asked to attend for two study visits, one week apart. Written informed consent will be taken before any study procedures are conducted.
At Study Visit 1, pre-imaging demographics and oral hygiene information will be collected. All occlusal surfaces of the teeth (12 possible molars and pre-molars) will be cleaned by the Dentist, by brushing with dental paste and rinsing with tap water and using a 3-in-1 air / water spray, according to a Tooth Cleaning Protocol. The Dentist will then perform an oral examination identifying and noting the ICDAS score of each tooth to be imaged with the Calcivis System. Colour photographs will be taken with a standard intra-oral camera of each selected molar and surrounding mucosa. Each tooth selected for imaging will be air dried for 5 seconds immediately before application of the disclosing solution and imaging. Images of one sound tooth and one unrestored erupted, or erupting third molar with an ICDAS score of 1,2 or 3 will be imaged. An additional two teeth may be imaged (remaining erupted / erupting third molar and / or any other molar with an ICDAS score of 1,2 or 3), up to a maximum of four teeth. Immediately after imaging has been completed, patients rinse out with tap water and a second colour photograph will be taken with a standard intra-oral camera of each selected molar and surrounding mucosa. Any adverse events will be recorded.
Post-imaging Questionnaires will be completed by all patients at the end of Study Visit 1, and User Questionnaires will be completed at the end of each Study Visit day.
Patients will return after one week for Study Visit 2. At this visit, a final oral examination will be conducted and colour will be taken with a standard intra-oral camera of each selected molar and surrounding mucosa. Any adverse events observed or volunteered by the patient will be recorded.
At the end of either Study Visit 1 or 2, the Dentist may share the images of the teeth imaged with the Calcivis System with the patient.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sound and Unsound Molars | Other | Device: Calcivis Caries Activity Imaging SystemImaging of unrestored sound molars (ICDAS 0), and third Molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging System |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcivis Caries Activity Imaging SystemTeeth imaged with the Calcivis Caries Activity Imaging System | Device | Sound and Unsound Molars |
Primary outcome
Percentage Agreement of Sound/Unsound Teeth Between ICDAS Score and Calcivis System
Time frame: Day 0
% 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.
Measure Safety of the Calcivis Caries Imaging System
Time frame: Day 0 and Day 7
Collection of all adverse events recorded and reported throughout the duration of the study
2 secondary outcomes
Patient Experience
Time frame: Day 0
User Experience
Time frame: 0 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Final Clinical Study Report issued
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Ormond, BDS,MGDS,FDS principal investigator
Clark and Watson Dental Practice
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcivis Caries Activity Imaging System in people with Dental Caries, run by Calcivis Ltd at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Agreement of Sound/Unsound Teeth Between ICDAS Score and Calcivis System (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2016.