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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

Evaluation of Reliability of the Near-infrared Imaging System (VistaCam iX Proxi) in Comparison With Digital Radiographic Findings and ICDAS-II in Detection of Approximal Carious Lesions.

Clinicaltrials.gov identifier NCT03923192

Recruitment Status Not yet recruiting

First Posted April 22, 2019

Last update posted February 7, 2020

Study Description

Brief summary:

The aim of this study is to evaluate the Clinical performance of the near-infrared imaging system VistaCam iX Proxi in comparison with digital radiographic findings and ICDAS-II in detection of approximal carious lesions.

  • Condition or Disease:Proximal Dental Caries
  • Intervention/Treatment: Device: Vistacam
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational [Patient Registry]
  • Estimated Enrollment: 80 participants
  • Observational Model: Ecologic or Community
  • Time Perspective: Prospective
  • Official Title: Evaluation of Validity of the Near-infrared Imaging System (VistaCam iX Proxi) in Comparison With Digital Radiographic Findings and ICDAS-II in Detection of Approximal Carious Lesions: Diagnostic Accuracy Study.
  • Estimated Study Start Date: September 2020
  • Estimated Primary Completion Date: May 2021
  • Estimated Study Completion Date: August 2021
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: vistacam
Device: Vistacam
device for early proximal caries detection
Outcome Measures
  • Primary Outcome Measures: 1. dental caries [ Time Frame: through study completion, an average of 1 year ]
    hidden proximal caries
Eligibility Criteria
  • Ages Eligible for Study: 15 to 50 Years (Child, Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
  • Sampling Method: Probability Sample
  • Study Population: Egyptian population
Criteria

Inclusion Criteria:

- Patients aged from 15 to 50 years.

- No gender restriction.

- Patients should have an acceptable oral hygiene level.

- Patients must have at least one posterior proximal caries

Exclusion Criteria:

- Patients with a compromised medical history.

- Severe or active periodontal disease.

- Heavy bruxism or a traumatic occlusion.

- Acute or chronic dental infection.

- Pregnant or breastfeeding women.

- Patients with posterior restorations on molars or premolars

Contacts and Locations
Contacts

Contact: Amr abdo Edrees, Assistant lecturer 002-01008221121 amr.edrees89@gmail.com

Contact: Mohamed Samy Elsayed, Assistant lecturer 002-01002071085 samodaser@gmail.com

Locations
Sponsors and Collaborators

Cairo University

More Information
  • Responsible Party: Cairo University
  • ClinicalTrials.gov Identifier: NCT03923192 History of Changes
  • Other Study ID Numbers: 2411
  • First Posted: April 22, 2019 Key Record Dates
  • Last Update Posted: February 7, 2020
  • Last Verified: February 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: Yes
  • Additional relevant MeSH terms: Dental Caries