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Caries Lesion Activity in Orthodontic Patients - Calcivis System

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ClinicalTrials.gov Identifier: NCT02771522
Recruitment Status : Recruiting
First Posted : May 13, 2016
Last Update Posted : June 23, 2017
Datatrial Ltd.
Information provided by (Responsible Party):
Calcivis Ltd

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 and ICDAS score at Visit 1. For each subject the percentage of teeth with each ICDAS score will be calculated. This will then be summarised over all subjects for each post-baseline visit and the ICDAS score will also be cross-tabulated with the presence/absence of luminescence from individual teeth for each visit.

Condition or disease Intervention/treatment
Dental Caries Device: Calcivis System

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Monitoring of Caries Lesion Activity in Orthodontic Patients With the Calcivis System
Actual Study Start Date : February 15, 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay
U.S. FDA Resources

Arm Intervention/treatment
Active post-othodontic lesions
Imaging with the Calcivis System
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. The images of the teeth are taken immediately before and after application of a small amount of disclosing solution. 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)
Other Name: Calcivis Caries Activity Imaging System

Primary Outcome Measures :
  1. Assessment of the Calcivis System for monitoring the activity levels of post orthodontic white spot lesions [ Time Frame: 0, 2, 4, 8 and 12 weeks ]
    Measured by the visible presence or absence of elevated bioluminescence on the tooth surface over a 12 week period post de-bond

Secondary Outcome Measures :
  1. Safety of Calcivis System [ Time Frame: 0 days, 2, 4, 8 and 12 weeks ]
    Collection of all adverse events throughout study duration

  2. Assessment of the value of the feedback / communication between patient and orthodontist, after using the Calcivis system [ Time Frame: 0 days and 12 weeks ]
    Measured by Patient and User Questionnaires

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient must be ≥ 12 years old
  2. 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
  3. Patient must have at least one, active white spot lesion identified by the Calcivs System immediately post de-bond
  4. Patient and / or parent or guardian must be willing and able to give written informed consent
  5. Patient and / or parent or guardian must be willing and able to adhere to study schedule

Exclusion Criteria:

  1. Any Patient with recent tooth bleaching (within previous two weeks of imaging with the Calcivis System) or within the follow-up period
  2. 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
  3. Pregnant and / or nursing mothers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02771522

Contact: Marjory Willins, BSc 00441316585152 mwillins@calcivis.com
Contact: Lorna Jackson 00441316585152 ljackson@calcivis.com

United Kingdom
Edinburgh Dental Institute Recruiting
Edinburgh, United Kingdom, EH3 9HA
Contact: Aman Ulhaq, BDS, MFDS, MSc, MOrth    00441315363979    aman.ulhaq@nhs.net   
Principal Investigator: Aman Ulhaq         
Sub-Investigator: Niall McGuinness         
Sub-Investigator: Eamon Howard-Bowles         
Sponsors and Collaborators
Calcivis Ltd
Datatrial Ltd.
Study Director: Aman Ulhaq, BDS, MFDS, MSc, MOrtho Edinburgh Dental Institutie
Principal Investigator: Niall McGuinness, FDS, MOrth, MSCD, DDS, PhD Edinburgh Dental Institute
Principal Investigator: Eamon Howard-Bowles, BDS, MFDS, PG Cert Edinbuirgh Dental Institute

Responsible Party: Calcivis Ltd
ClinicalTrials.gov Identifier: NCT02771522     History of Changes
Other Study ID Numbers: CAL-03-2015
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Final Clinical Study report to be issued

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Calcivis Ltd:
Caries, Acitivity, Demineralsiation

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases