Caries Lesion Activity in Orthodontic Patients - Calcivis System

NCT02771522 | Completed Results

• 1 other identifier: CAL-03-2015
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Caries, Acitivity, Demineralsiation

Outcome Measures

Primary Outcomes (2)

• Presence or Absence of Elevated Luminescence

  Percentage of active teeth showing luminescence (as measured by Calcivis System imaging) over time

  0, 2, 4, 8 and 12 weeks

• Presence or Absence of Elevated Luminescence

  Percentage of active teeth showing luminescence (as measured by Calcivis System imaging) over time, per Investigator

  0, 2, 4, 8 and 12 weeks post de-bond

Secondary Outcomes (4)

• Number of Non-patient Related Adverse Events With the Calcivis System

  0 days, 2, 4, 8 and 12 weeks

• Patient Experience

  Baseline

• Patient Experience

  Final Visit - either 8 or 12 weeks post debond

• User Questionnaires

  Baseline visit

Study Arms (1)

Active post-othodontic lesions

OTHER

Imaging with the Calcivis System

Device: Calcivis System

Interventions

Calcivis System DEVICE

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)

Also known as: Calcivis Caries Activity Imaging System

Active post-othodontic lesions

Eligibility Criteria

• Age: 12 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be ≥ 12 years old
• Patient must have had orthodontic appliances placed on the upper incisors and / or canines for at least 12 months, and be ready for de-bond
• Patient must have at least one, active white spot lesion identified by the Calcivs System immediately post de-bond
• Patient and / or parent or guardian must be willing and able to give written informed consent
• Patient and / or parent or guardian must be willing and able to adhere to study schedule

You may not qualify if:

• Any Patient with recent tooth bleaching (within previous two weeks of imaging with the Calcivis System) or within the follow-up period
• Any patient currently taking part in a clinical research study, or who has taken part in a clinical research study in the previous three months
• Pregnant and / or nursing mothers

Sponsors & Collaborators

• Calcivis Ltd: lead
• Medsource UK Ltd.: collaborator

Study Sites (1)

Edinburgh Dental Institute

Edinburgh, EH3 9HA, United Kingdom

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Director of Clinical Research
• Organization: Calcivis Ltd

mwillins@calcivis.com

+44 131 658 5152

Study Officials

• Aman Ulhaq, BDS, MFDS, MSc, MOrtho

  Edinburgh Dental Institutie

  STUDY DIRECTOR

• Niall McGuinness, FDS, MOrth, MSCD, DDS, PhD

  Edinburgh Dental Institute

  PRINCIPAL INVESTIGATOR

• Eamon Howard-Bowles, BDS, MFDS, PG Cert

  Edinbuirgh Dental Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: May 13, 2016
• Study Start: February 15, 2017
• Primary Completion: June 5, 2018
• Study Completion: June 5, 2018
• Last Updated: February 28, 2019
• Results First Posted: February 28, 2019

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)