Calcivis System - Orthodontic Caries Lesion Activity Behaviour
Research type
Research Study
Full title
Clinical Study to Evaluate the Calcivis System for Monitoring Caries Lesion Activity Behaviour in Orthodontic Patients
IRAS ID
187821
Contact name
Adam Christie
Contact email
Sponsor organisation
Calcivis Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 7 months, 22 days
Research summary
Can the Calcivis System monitor the activity status of post-orthodontic treatment white spot lesions, as an indicator of gradual arrest of caries lesion activity (re-mineralisation / repair) or continuing lesion activity (on-going demineralisation) over time.
This is a prospective, non-randomised, post-approval clinical study, sponsored by Calcivis Ltd. to follow 45 patients from NHS hospital orthodontic clinics with post debond active lesions.
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, associated with pain and disease. Detecting, assessing, diagnosing and treating such lesions are core activities in dentistry. Currently the main detection and diagnostic aids are visual inspection, the use of a probe and X-ray images. However, determination of the activity status of a lesion (how likely it is to progress) is required to assess treatment needs. Current methods are problematic and involve the clinician's subjective assessment and/or monitoring lesion progression over time.
The device under evaluation comprises a handheld specialized intra-oral camera which takes images of the lesion on the tooth surface immediately before and after application of a disclosing solution, containing a photo-protein which detects free calcium ions on the tooth surface, and produces a visible light signal if the caries lesion is active.At Visit 1, patients who are identified as having visible lesions following de-bond, will have their teeth imaged with the Calcivis System. From the images, if activity is shown, these patients will be followed up at 2, 4, 8 and 12 weeks post de-bond. Patient and User Questionnaires will be completed at the baseline and 12 week visits.
The Calcivis System will benefit patients as any lesion activity can be determined at a single visit without the need for X-rays or other examination.
REC name
South East Scotland REC 01
REC reference
16/SS/0036
Date of REC Opinion
15 Mar 2016
REC opinion
Further Information Favourable Opinion