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

Dental Caries Clinical Trial

Official title:

Post-Approval Clinical Study to Evaluate the Safety and Performance of the Calcivis Caries Activity Imaging System in a Clinical Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02098304
• Other study ID #: CAL-01-2013
• Status: Completed
• Phase: N/A
• First received: March 20, 2014
• Last updated: February 10, 2015
• Start date: May 2014
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: Calcivis Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 25 Years

Eligibility

Inclusion Criteria:

1. Patient must be 16 to 25 years old

2. Patient must have at least one unrestored molar identified as sound according to the ICDAS coding system

3. 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)

4. Patient must be willing and able to give written informed consent

5. Patient must be willing and able to adhere to study schedule

Exclusion Criteria:

1. Recent tooth bleaching (within previous two weeks of imaging with the Calcivis System)

2. On-going re-mineralisation treatment including, but not limited to high concentration prescription fluoride toothpaste

3. Any patient with a fixed orthodontic appliance

4. Any patient currently taking part in a clinical research study, or has taken part in a clinical research study in the previous three months

5. Pregnant and / or nursing mothers

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Dental Caries

Intervention

Device:
• Calcivis Caries Activity Imaging System
Unrestored sound molars imaged with the Calcivis Caries Activity Imaging System
• Calcivis Caries Activity Imaging System
Unrestored erupting or erupted third molars, with ICDAS score of 1, 2 or 3, imaged with the Calcivis Caries Activity Imaging System

Locations

Country	Name	City	State
United Kingdom	Bathgate Smile Centre	Bathgate
United Kingdom	Downie, Haper and Shanks Dental Practice	Edinburgh
United Kingdom	Clark and Watson Dental Practice	Falkirk

Sponsors (1)

Lead Sponsor	Collaborator
Calcivis Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Measure User Experience with the Calcivis Caries Activity Assessment System	Measure by completion of both Patient and User Questionnaires	Day 0 and Day 7	No
Primary	Measure of Performance of the Calcivis Caries Activity Imaging System	Measured by the presence or absence of elevated luminescence on the tooth surface determined from intra-oral image mapping of that surface (with or without) lesions	Day 0 and Day 7	No
Secondary	Measure Safety of the Calcivis Caries Imaging System	Collection of all adverse events	Day 0 and Day 7	Yes