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Reliability of Fluorescent Camera in Diagnosis of Occlusal Carious Lesion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03224962
Recruitment Status : Unknown
Verified July 2017 by Shimaa Maher Zenhom Abd El Rahman, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : July 21, 2017
Last Update Posted : July 25, 2017
Information provided by (Responsible Party):
Shimaa Maher Zenhom Abd El Rahman, Cairo University

Brief Summary:
This study will be conducted to compare the diagnostic predictive values of a light induced fluorescence camera and Caries detection dye versus visual assessment method in identification of occlusal carious lesion.

Condition or disease Intervention/treatment
Caries Device: fluorescence camera

Detailed Description:
A total of 43 volunteer patients will be assigned in this study. Each patient must have at least two occlusal carious lesions. Each lesion will be evaluated by three diagnostic methods (D), where D1 represents light induced fluorescence camera, D2 represents Caries detection dye. And D3 represents visual assessment method (ICDAS criteria)

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Study Type : Observational
Estimated Enrollment : 43 participants
Observational Model: Other
Time Perspective: Other
Official Title: Reliability of Fluorescent Camera and Caries Detection Dye Versus Visual- Assessment in Diagnosis of Occlusal Carious Lesion in Adult Patients: Invivo Diagnostic Study
Estimated Study Start Date : August 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Group/Cohort Intervention/treatment
diagnostic tool
Light induced fluorescence camera Caries detection dye. visual assessment method (ICDAS criteria)
Device: fluorescence camera
drug - diagnostic test
Other Names:
  • Caries detection dye.
  • visual assessment method (ICDAS criteria)

Primary Outcome Measures :
  1. Reliability and level of agreement between operators for all diagnostic methods. [ Time Frame: 3 months ]
    It will be assessed using reliability & reproducibility by kappa strength measuring unit

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult populations suffering from occlusal caries.

Inclusion Criteria:

  • Patients should be over 18 Years old
  • Patient should have good oral hygiene and general health
  • patients With at least 2 non-cavitated first and/or second molar teeth in each quadrant of maxilla or mandible

Exclusion Criteria:

  • Known allergy to any component of the dyes used.
  • Patients having caries at proximal, buccal, lingual surface.
  • Previously placed sealants or restorations.
  • Bruxism or malocclusion

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 identifier (NCT number): NCT03224962

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Contact: shimaa M Zenhom Abd El Rahman, B A (002)01001036094
Contact: amir hafez, lecturer (002)01100001278

Sponsors and Collaborators
Cairo University
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Principal Investigator: Mona I Riad, Professor Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.

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Responsible Party: Shimaa Maher Zenhom Abd El Rahman, Assistant lecturer, Cairo University Identifier: NCT03224962    
Other Study ID Numbers: CEBC-CU-2017-07-28
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017
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: No
Keywords provided by Shimaa Maher Zenhom Abd El Rahman, Cairo University:
pit and fissure caries
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Salicylic Acid
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents