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Trial record 44 of 110 for:    CALCIUM CATION

Caries Lesion Activity in Orthodontic Patients - Calcivis System

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ClinicalTrials.gov Identifier: NCT02771522
Recruitment Status : Completed
First Posted : May 13, 2016
Results First Posted : February 28, 2019
Last Update Posted : February 28, 2019
Sponsor:
Collaborator:
Medsource UK 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. This will then be summarised over all subjects for each post-baseline visit.


Condition or disease Intervention/treatment Phase
Dental Caries Device: Calcivis System Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 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
Actual Primary Completion Date : June 5, 2018
Actual Study Completion Date : June 5, 2018

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. 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)
Other Name: Calcivis Caries Activity Imaging System




Primary Outcome Measures :
  1. Presence or Absence of Elevated Luminescence [ Time Frame: 0, 2, 4, 8 and 12 weeks ]
    Percentage of active teeth showing luminescence (as measured by Calcivis System imaging) over time

  2. Presence or Absence of Elevated Luminescence [ Time Frame: 0, 2, 4, 8 and 12 weeks post de-bond ]
    Percentage of active teeth showing luminescence (as measured by Calcivis System imaging) over time, per Investigator


Secondary Outcome Measures :
  1. Number of Non-patient Related Adverse Events With the Calcivis System [ Time Frame: 0 days, 2, 4, 8 and 12 weeks ]
    All adverse events and device deficiencies were collected throughout the study on Adverse Event Forms

  2. Patient Experience [ Time Frame: Baseline ]
    Completion of Patient Questionnaires after imaging with the Calcivis System

  3. Patient Experience [ Time Frame: Final Visit - either 8 or 12 weeks post debond ]
    Completion of Patient Questionnaires after imaging with the Calcivis System at patient's final visit

  4. User Questionnaires [ Time Frame: Baseline visit ]
    Completion of User Questionnaires after imaging with the Calcivis System



Information from the National Library of Medicine

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

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


Locations
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United Kingdom
Edinburgh Dental Institute
Edinburgh, United Kingdom, EH3 9HA
Sponsors and Collaborators
Calcivis Ltd
Medsource UK Ltd.
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Calcivis Ltd:
Statistical Analysis Plan  [PDF] April 25, 2018
Study Protocol  [PDF] November 8, 2017


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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
Results First Posted: February 28, 2019
Last Update Posted: February 28, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases