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Trial record 18 of 1201 for:    tooth decay

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.

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ClinicalTrials.gov Identifier: NCT03923192
Recruitment Status : Not yet recruiting
First Posted : April 22, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Amr Abdel Fattah Mahmoud Edrees, Cairo University

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 Intervention/treatment
Proximal Dental Caries Device: Vistacam

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 80 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
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 : May 1, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Group/Cohort Intervention/treatment
vistacam Device: Vistacam
device for early proximal caries detection

ICDAS II
Digital radiograph



Primary Outcome Measures :
  1. dental caries [ Time Frame: through study completion, an average of 1 year ]
    hidden proximal caries



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years 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

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): NCT03923192


Contacts
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Contact: Amr abdo Edrees, Assistant lecturer 002-01008221121 amr.edrees89@gmail.com
Contact: Mohamed Samy Elsayed, Assistant lecturer 002-01002071085 samodaser@gmail.com

Sponsors and Collaborators
Cairo University

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Responsible Party: Amr Abdel Fattah Mahmoud Edrees, assistant lecturer, 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: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

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