Accuracy Of Sopro-Life Camera In Comparison With ICDAS II For Detection Of Initial Caries
Primary Purpose
Caries, Dental
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
light induced fluorescence camera
Sponsored by
About this trial
This is an interventional diagnostic trial for Caries, Dental
Eligibility 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 with fissure discoloration
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
- Dentistry Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
ICDAS-II
Arm Description
According to the international caries detection and assessment system (ICDAS-II). The visual examination was performed using the ICDAS-II criteria, which provides a standardized method of lesion detection. The ICDAS-II detection codes for coronal categories the score will be 0 =surface not restored or sealant then according to caries categories range from 0 to 6 depending on the severity of the lesion with the corresponding clinical views.
Outcomes
Primary Outcome Measures
reliability and reproducibility of intra oral light fluorescence camera using kappa strength
in primary caries diagnosis
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03586713
Brief Title
Accuracy Of Sopro-Life Camera In Comparison With ICDAS II For Detection Of Initial Caries
Official Title
Accuracy Of Sopro-Life Camera In Comparison With ICDAS II For Detection Of Initial Caries In Adult Patients With Non Cavitated Pits And Fissure Discoloration: Diagnostic Accuracy Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 2019 (Anticipated)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
May 2019 (Anticipated)
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
Yes
5. Study Description
Brief Summary
This study will be conducted to assess diagnostic predictive values of a light induced fluorescence intraoral camera versus those of the visual-tactile assessment method according to modified ICDAS-II criteria in clinical
Detailed Description
volunteers patients will be assigned in this study. Each patient should have at least one posterior tooth with pits and fissure discoloration and maximum 4 teeth. The teeth will be evaluated by two diagnostic methods (D), where D1 represents visual-tactile assessment method (ICDAS-II) and D2 represents light induced fluorescence intraoral camera.Three operators, the researcher and the 2 supervisors, from the Conservative Dentistry Department, Faculty of Dentistry, Cairo University, will be the examiners in this study. Each examiner will record the dental findings using both the visual- tactile assessment method and the fluorescent-aided identification method. The visual-tactile assessment method includes the use of mirror, probe under good illumination condition, while the fluorescent-aided identification method will be performed by light induced fluorescence intraoral camera.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries, Dental
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Screening of patients that come to the conservative dentistry department seeking dental care will continue until the target population is achieved. The patients' teeth will be subjected to visual examination and diagnosis using dental charts. Once the patients that are potentially eligible for this study are identified, they will be contacted by the research investigator who will explain the study and ascertains the patient's interest. If interested, more detailed evaluations and preparations are made
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ICDAS-II
Arm Type
Other
Arm Description
According to the international caries detection and assessment system (ICDAS-II). The visual examination was performed using the ICDAS-II criteria, which provides a standardized method of lesion detection. The ICDAS-II detection codes for coronal categories the score will be 0 =surface not restored or sealant then according to caries categories range from 0 to 6 depending on the severity of the lesion with the corresponding clinical views.
Intervention Type
Diagnostic Test
Intervention Name(s)
light induced fluorescence camera
Intervention Description
The light induced fluorescence intraoral camera works with a visible blue light frequency (wavelength 450 nm) for the illumination of the dental surface and produces an overlapping image of the green fluorescence image on the image of the white light. The green fluorescence image is considered an indicator of healthy dental tissues. The colour of the fluorescence signal is green when the dentin is healthy. The healthy enamel is blue due to the scattered green light of the dentin, despite the lack of a fluorescence signal. On the other hand, caries can be easily detected by dark red fluorescence.
Primary Outcome Measure Information:
Title
reliability and reproducibility of intra oral light fluorescence camera using kappa strength
Description
in primary caries diagnosis
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 with fissure discoloration
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
noura alzayyat, phd
Phone
01006454668
Email
noura.alzayyat@hotmail.com
Facility Information:
Facility Name
Dentistry Cairo University
City
Cairo
ZIP/Postal Code
11211
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
noura alzayyat, phd
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Accuracy Of Sopro-Life Camera In Comparison With ICDAS II For Detection Of Initial Caries
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