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NCT03224962 Clinical Trial

Reliability of Fluorescent Camera in Diagnosis of Occlusal Carious Lesion

Caries Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03224962
Other study ID # CEBC-CU-2017-07-28
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 13, 2017
Last updated July 24, 2017
Start date August 2017
Est. completion date March 2018

Study information
Verified date July 2017
Source Cairo University
Contact shimaa M Zenhom Abd El Rahman, B A
Phone (002)01001036094
Email shimaa-maher@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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)

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 43
Est. completion date March 2018
Est. primary completion date December 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• fluorescence camera
drug - diagnostic test

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Outcome
Type Measure Description Time frame Safety issue
Primary Reliability and level of agreement between operators for all diagnostic methods. It will be assessed using reliability & reproducibility by kappa strength measuring unit 3 months
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