Clinical Effectiveness of(VistaProof)in Comparison With ICDAS-II & Histological Validation for Detecting Occlusal Caries

August 13, 2021 updated by: Mohamed samy El-sayed

Clinical Effectiveness of Quantitative Light Fluorescence Based Device (Vistacam Proof) in Comparison With ICDAS-II and Histological Validation in Detection of Initial Pits and Fissures Caries:: Diagnostic Accuracy Study

a diagnostic accuracy study control trial is to be held to evaluate the Clinical performance of quantitative light fluorescence based device (Vistacam Proof) in comparison with the visual examination and histological validation in detection of initial pits and fissures caries

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

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

Study Locations

  • Egypt
      • Cairo, Egypt
        • The British University in Egypt

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

15 years to 50 years (ADULT, CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Egyptian population

Description

Inclusion Criteria:

  • Patients aged from 15 to 50 years.
  • Patient at least has one posterior pits and fissure occlusal caries.
  • No gender restriction
  • Co-operative patients who signed the informed consent.
  • Good general health
  • Acceptable oral health

Exclusion Criteria:

  • Pregnancy.
  • Disabilities.
  • Systemic disease or severe medical complications.
  • Allergic history concerning methacrylate.
  • Rampant caries.

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
vistacam
Device: vistacam proof
Light fluorescence device
ICDAS II
Other: ICDASII
visual examination
Fissurotomy
Device: vistacam proof
Light fluorescence device
Other: ICDASII
visual examination
Procedure: fissurotomy
histological validation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pits and fissure caries
Time Frame: through study completion, an average of 1 year
occlusal pits and fissure caries in posterior teeth non-cavitated
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Mohamed samy El-sayed

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 (ACTUAL)

May 1, 2020

Primary Completion (ACTUAL)

May 13, 2021

Study Completion (ACTUAL)

August 9, 2021

Study Registration Dates

First Submitted

April 25, 2019

First Submitted That Met QC Criteria

May 4, 2019

First Posted (ACTUAL)

May 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 19, 2021

Last Update Submitted That Met QC Criteria

August 13, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2222

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

Yes

product manufactured in and exported from the U.S.

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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