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Safety and Performance Evaluation of the Calcivis System

NCT02780856 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2019-02-19

Study results available
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Summary

This is a prospective, multi-centre clinical study to evaluate the safety and performance of the Calcivis Caries Activity Imaging System. Dentists will identify tooth surfaces as either sound (inactive) or unsound (active caries lesion present) according to ICDAS staging (International Caries Detection and Assessment System). Images of the tooth surface will be taken with the Calcivis System immediately before and after application of a disclosing solution containing a bioluminescent protein. Presence or absence of elevated luminescence on the images will indicate activity / inactivity of the presence or absence of active demineralisation on the tooth surfaces.

The study will be deemed a success if there is 70% agreement and above between:

1. elevated luminescence and the presence of active caries as determined by the dentists, and
2. absence of luminescence and the determination of a sound tooth surface by the dentists.

Conditions

  • Dental Caries

Interventions

DEVICE

Imaging with the Calcivis System

Following identification of both sound and unsound tooth surfaces, the teeth will be air-dried and a black \& white and luminescent image of each tooth taken. The images of each tooth will be overlaid and a resulting demineralization map of the tooth produced, indicating areas of elevated bioluminescence corresponding to free calcium ions on the surface of the tooth (active caries)

Sponsors & Collaborators

  • Medsource UK Ltd.

    collaborator UNKNOWN

  • Calcivis Ltd

    lead INDUSTRY

Principal Investigators

  • Neil Shanks, BDS, MJDF · Harper, Downie and Shanks Dental Practice

  • Elaine Downie, BDS · Harper, Downie and Shanks Dental Practice

  • Fraser Morrison, BDS · Bathgate Smile Centre

  • Steve Martin, BDS, MJDF · Edinburgh Periodontics

  • Agnieszka Nohawica, BDS · Bosco Dental Studio

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-14
Primary Completion
2017-05-04
Completion
2017-06-21

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02780856 on ClinicalTrials.gov