Back to resultsEvaluation 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.
Primary Purpose
Proximal Dental Caries
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Vistacam
Bitewing radiograph
Sponsored by
About this trial
This is an interventional diagnostic trial for Proximal Dental Caries
Eligibility Criteria
Inclusion Criteria:
- Patients aged from 18 to 40 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
Sites / Locations
- The British University in Egypt
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
ICDAS II
Arm Description
Visual tactile examination based on ICDASII scoring system
Outcomes
Primary Outcome Measures
dental caries
hidden proximal caries
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03923192
Brief Title
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.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proximal Dental Caries
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
screening of the Patients who join the Conservative Dentistry Department clinic will be done until the target population is achieved. The Patients' teeth will be subjected to visual examination and diagnosis using dental charts. once the patient is eligible to be included in this study, they will be contacted by the research investigator who will explain the study and identify the patient interests .If the patient show interest ,further clarification and discussing wil be held .
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ICDAS II
Arm Type
Other
Arm Description
Visual tactile examination based on ICDASII scoring system
Intervention Type
Device
Intervention Name(s)
Vistacam
Intervention Description
device for early proximal caries detection
Intervention Type
Radiation
Intervention Name(s)
Bitewing radiograph
Intervention Description
radiograph for proximal caries detection
Primary Outcome Measure Information:
Title
dental caries
Description
hidden proximal caries
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients aged from 18 to 40 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
Facility Information:
Facility Name
The British University in Egypt
City
Cairo
State/Province
Other
ZIP/Postal Code
223453
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
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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