Safety and Performance Evaluation of the Calcivis System

NCT02780856 | Completed Results

• 1 other identifier: CAL-02-2014
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 4

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

Conditions

Dental Caries

Keywords

Caries Activity Demineralisation; Demineralisation

Outcome Measures

Primary Outcomes (2)

• Number of Teeth Identified as Sound or Unsound by the Calcivis System That Were in Agreement With the Dentist's Assessment

  Agreement between the dentist's assessment (ICDAS staging) of sound (inactive) and unsound (active) teeth and the visible presence of elevated bioluminescence on the tooth surface using the Calcivis System

  Day 0

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

  Collection of all Adverse Events throughout the duration of the study

  Day 0 and Day 7

Secondary Outcomes (2)

• Patient Experience

  Day 0

• User Experience

  Day 0

Study Arms (1)

Sound and unsound teeth

OTHER

Sound (ICDAS 0) canines or incisors and unsound (ICDAS 2 or 3) molars or pre-molars - imaging with the Calcivis System

Device: Imaging with the Calcivis System

Interventions

Imaging with the Calcivis System DEVICE

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)

Also known as: Calcivis Caries Activity Imaging System

Sound and unsound teeth

Eligibility Criteria

• Age: 6 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 6 years or older
• Patient must have one unrestored, accessible, free smooth buccal surface on a canine or incisor, away from the gingival surface identified with no visible lesions (coded ICDAS 0) and/or
• Patient must have one unrestored, accessible, erupting or erupted molar or premolar with a visible lesion identified as (coded ICDAS 2 or 3) in a plaque stagnation area
• 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)
• Any patient having on-going re-mineralization treatment including, but not limited to high concentration prescription fluoride toothpaste
• Any patient with a fixed orthodontic appliance
• Any patient currently taking part in a clinical research study, or 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 (4)

Bosco Dental Studio

Dalkeith, Edinburgh, EH22 2RF, United Kingdom

Location

Bathgate Smile Centre

Bathgate, EH48 2SS, United Kingdom

Location

Harper, Downie and Shanks Dental Practice

Edinburgh, EH17 8HP, United Kingdom

Location

Edinburgh Periodontics

Edinburgh, EH9 1AN, United Kingdom

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

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

mwillins@calcivis.com

+ 44 131 658 5152

Study Officials

• Neil Shanks, BDS, MJDF

  Harper, Downie and Shanks Dental Practice

  STUDY DIRECTOR

• Elaine Downie, BDS

  Harper, Downie and Shanks Dental Practice

  PRINCIPAL INVESTIGATOR

• Fraser Morrison, BDS

  Bathgate Smile Centre

  PRINCIPAL INVESTIGATOR

• Steve Martin, BDS, MJDF

  Edinburgh Periodontics

  PRINCIPAL INVESTIGATOR

• Agnieszka Nohawica, BDS

  Bosco Dental Studio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

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 24, 2016
• Study Start: January 14, 2017
• Primary Completion: May 4, 2017
• Study Completion: June 21, 2017
• Last Updated: February 19, 2019
• Results First Posted: February 19, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)