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出境医 / 临床实验 / Reliability of Secondary Caries Detection Around Composite Restoration Using Light Induced Fluorescence

Reliability of Secondary Caries Detection Around Composite Restoration Using Light Induced Fluorescence

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

Condition or disease Intervention/treatment Phase
Secondary Caries Diagnostic Test: light induced fluorescence intraoral camera Not Applicable

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
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: Reliability of Secondary Caries Detection Around Composite Restoration Using Light Induced Fluorescence in Comparison to Visual Tactile Method: Diagnostic Accuracy Study
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018
Arms and Interventions
Arm Intervention/treatment
visual tactile method
visual tactile method using the modified USHPS critiria
 Diagnostic Test: light induced fluorescence intraoral camera
intraoral oral light induced fluorescence diagnostic camera
Other Name: soprolife camera
Outcome Measures
Primary Outcome Measures :
  1. reliability and reproducibility of intra oral light fluorescence camera using kappa strength [ Time Frame: 6 months ]
    in secondary craies diagnosis around composite restorations


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations

Contacts
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Contact: Haneen elmoselhy, master 01003778829 noonyelmoselhy@gmail.com

Locations
Layout table for location information
Egypt
Cairo University
Cairo, Egypt, 11221
Contact: haneen elmoselhy, master         
Sponsors and Collaborators
Cairo University
Tracking Information
First Submitted Date  ICMJE June 4, 2018
First Posted Date  ICMJE June 15, 2018
Last Update Posted Date August 13, 2018
Estimated Study Start Date  ICMJE August 2018
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2018) 		reliability and reproducibility of intra oral light fluorescence camera using kappa strength [ Time Frame: 6 months ]
in secondary craies diagnosis around composite restorations
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reliability of Secondary Caries Detection Around Composite Restoration Using Light Induced Fluorescence
Official Title  ICMJE Reliability of Secondary Caries Detection Around Composite Restoration Using Light Induced Fluorescence in Comparison to Visual Tactile Method: Diagnostic Accuracy Study
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Diagnostic
Condition  ICMJE Secondary Caries
Intervention  ICMJE Diagnostic Test: light induced fluorescence intraoral camera
intraoral oral light induced fluorescence diagnostic camera
Other Name: soprolife camera
Study Arms  ICMJE visual tactile method
visual tactile method using the modified USHPS critiria
Intervention: Diagnostic Test: light induced fluorescence intraoral camera
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 13, 2018) 		29
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2018
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03558113
Other Study ID Numbers  ICMJE CEBD-CU-2018-06-04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Haneen ahmed shafik elmoselhy, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cairo University
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP