Back to resultsReliability of Secondary Caries Detection Around Composite Restoration Using Light Induced Fluorescence
Primary Purpose
Secondary Caries
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
light induced fluorescence intraoral camera
Sponsored by
About this trial
This is an interventional diagnostic trial for Secondary Caries
Eligibility Criteria
Inclusion Criteria:
- Patients should be over 18 years of age. Patients should have an acceptable oral hygiene level. Patients must have at least one posterior resin composite restoration
Exclusion Criteria:
Patients with a compromised medical history. Severe or active periodontal disease. Heavy bruxism or a traumatic occlusion.
Sites / Locations
- Cairo University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
visual tactile method
Arm Description
visual tactile method using the modified USHPS critiria
Outcomes
Primary Outcome Measures
reliability and reproducibility of intra oral light fluorescence camera using kappa strength
in secondary craies diagnosis around composite restorations
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03558113
Brief Title
Reliability of Secondary Caries Detection Around Composite Restoration Using Light Induced Fluorescence
Official Title
Reliability of Secondary Caries Detection Around Composite Restoration Using Light Induced Fluorescence in Comparison to Visual Tactile Method: Diagnostic Accuracy Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2018 (Anticipated)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2018 (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
A total of 29 volunteer patients will be assigned in this study. Each patient should have one resin composite restoration. The restoration will be evaluated by two diagnostic methods (D), where D1 represents visual-tactile assessment method (modified USPHS) and D2 represents light induced fluorescence intraoral camera
Detailed Description
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
Secondary Caries
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' restorations 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
29 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
visual tactile method
Arm Type
Other
Arm Description
visual tactile method using the modified USHPS critiria
Intervention Type
Diagnostic Test
Intervention Name(s)
light induced fluorescence intraoral camera
Other Intervention Name(s)
soprolife camera
Intervention Description
intraoral oral light induced fluorescence diagnostic camera
Primary Outcome Measure Information:
Title
reliability and reproducibility of intra oral light fluorescence camera using kappa strength
Description
in secondary craies diagnosis around composite restorations
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients should be over 18 years of age. Patients should have an acceptable oral hygiene level. Patients must have at least one posterior resin composite restoration
Exclusion Criteria:
Patients with a compromised medical history. Severe or active periodontal disease. Heavy bruxism or a traumatic occlusion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haneen elmoselhy, master
Phone
01003778829
Email
noonyelmoselhy@gmail.com
Facility Information:
Facility Name
Cairo University
City
Cairo
ZIP/Postal Code
11221
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
haneen elmoselhy, master
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Reliability of Secondary Caries Detection Around Composite Restoration Using Light Induced Fluorescence
We'll reach out to this number within 24 hrs