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Caries Lesion Activity in Orthodontic Patients - Calcivis System

NCT02771522 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-02-28

Study results available
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Summary

This is a prospective, single-centre clinical study to monitor caries lesion activity in orthodontic patients with the Calcivis System over a 12 week period. Dentists will identify patients who have had dental appliances in place for a minimum of 12 months and have visible white spot lesions on the anterior surfaces of incisors and / or canines at de-bond. Following de-bond, images of the tooth surface will be taken with the Calcivis System. Presence or absence of elevated luminescence on the images will indicate activity / inactivity. Only patients with at least one tooth identified as active with the Calcivis System will continue in the study and be followed up at 2, 4, 8 and 12 weeks de-bond. Images of the active teeth will be taken with the Calcivis System as before, at each follow-up visit.

The percentage of teeth showing luminescence using the Calcivis System will be calculated and summarised for all subjects for each post-baseline visit, and additionally by Investigator. This will then be summarised over all subjects for each post-baseline visit.

Conditions

  • Dental Caries

Interventions

DEVICE

Calcivis System

Following de-bond, and identification of active post-orthodontic white spot lesions at baseline with the Calcivis System, each active tooth will be again be imaged at 2, 4, 8 and 12 weeks. Both black \& white and luminescent images images of the teeth are taken. The images of each tooth are 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

  • Aman Ulhaq, BDS, MFDS, MSc, MOrtho · Edinburgh Dental Institutie

  • Niall McGuinness, FDS, MOrth, MSCD, DDS, PhD · Edinburgh Dental Institute

  • Eamon Howard-Bowles, BDS, MFDS, PG Cert · Edinbuirgh Dental Institute

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2017-02-15
Primary Completion
2018-06-05
Completion
2018-06-05

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 NCT02771522 on ClinicalTrials.gov