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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03940170

Recruitment Status Not yet recruiting

First Posted May 7, 2019

Last update posted May 7, 2019

Study Description

Brief summary:

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

  • Condition or Disease:Light Fluorescence Device
  • Intervention/Treatment: Device: vistacam proof
    Other: ICDASII
    Procedure: fissurotomy
  • Phase: N/A
Detailed Description


Study Design
  • Study Type: Observational
  • Estimated Enrollment: 24 participants
  • Observational Model: Other
  • Time Perspective: Prospective
  • Official Title: 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
  • Estimated Study Start Date: June 2019
  • Estimated Primary Completion Date: August 2020
  • Estimated Study Completion Date: September 2020
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Fissurotomy
Device: vistacam proof
Light fluorescence device

visual examination

Procedure: fissurotomy
histological validation
: vistacam
Device: vistacam proof
Light fluorescence device
visual examination
Outcome Measures
  • Primary Outcome Measures: 1. pits and fissure caries [ Time Frame: through study completion, an average of 1 year ]
    occlusal pits and fissure caries in posterior teeth non-cavitated
Eligibility Criteria
  • Ages Eligible for Study: 15 to 50 Years (Child, Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers:
  • Sampling Method: Probability Sample
  • Study Population: Egyptian population

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.

Contacts and Locations

Contact: Mohamed sa EL-sayed, Assistant lecturer 01002071085 samodaser@gmail.com

Contact: Amr Mahmoud Edrees, Assistant lecturer 002-01008221121 amr.edrees@gmail.com

Sponsors and Collaborators

Mohamed samy El-sayed

More Information
  • Responsible Party: Mohamed samy El-sayed
  • ClinicalTrials.gov Identifier: NCT03940170 History of Changes
  • Other Study ID Numbers: 2222
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: May 7, 2019
  • Last Verified: May 2019
  • Individual Participant
    Data (IPD) Sharing
  • Plan to Share IPD: Undecided
  • 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.: Yes