Reliability of Fluorescent Camera in Diagnosis of Occlusal Carious Lesion

July 24, 2017 updated by: Shimaa Maher Zenhom Abd El Rahman, Cairo University

Reliability of Fluorescent Camera and Caries Detection Dye Versus Visual- Assessment in Diagnosis of Occlusal Carious Lesion in Adult Patients: Invivo Diagnostic Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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)

Study Type

Observational

Enrollment (Anticipated)

43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult populations suffering from occlusal caries.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2017

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

July 13, 2017

First Submitted That Met QC Criteria

July 19, 2017

First Posted (Actual)

July 21, 2017

Study Record Updates

Last Update Posted (Actual)

July 25, 2017

Last Update Submitted That Met QC Criteria

July 24, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBC-CU-2017-07-28

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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