Calcivis System - Safety and Performance - Active Demineralization
Research type
Research Study
Full title
Clinical Study to Evaluate the Safety and Performance of the Calcivis System for Identifying Active Demineralization on Tooth Surfaces
IRAS ID
181910
Contact name
Adam Christie
Contact email
Sponsor organisation
Calcivis Ltd.
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 3 days
Research summary
Does the Calcivis System identify active demineralization on tooth surfaces in a safe and consistent manner.
This is a prospective, non-randomised, post-approval clinical study, sponsored by Calcivis Ltd. which will be conducted in four general dental practices by five Investigators. A maximum of 180 patients will be recruited.
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 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 hand-held specialized intra-oral camera which takes images of the surface of the tooth 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 a caries lesion is undergoing active demineralization.
Visit 1 - following oral examination, patients who have teeth identified with a suspected active caries lesion and/or a sound tooth with no lesion, will have their teeth imaged using the Calcvis System. From the images, the dentist will interpret whether the teeth are actively demineralizing or not. Patient and User Questionnaires/Visual Analogue Scales will be completed. Patients return for Visit 2, 7 to 14 days post imaging, for a final oral examination.
The Calcivis System will benefit patients as caries lesion activity can be determined at a single visit without the need for X-rays or other examinations.
REC name
South East Scotland REC 02
REC reference
15/SS/0231
Date of REC Opinion
18 Dec 2015
REC opinion
Favourable Opinion