Accuracy Of Sopro-Life Camera In Comparison With ICDAS II For Detection Of Initial Caries

Accuracy Of Sopro-Life Camera In Comparison With ICDAS II For Detection Of Initial Caries In Adult Patients With Non Cavitated Pits And Fissure Discoloration: Diagnostic Accuracy Study

This study will be conducted to assess diagnostic predictive values of a light induced fluorescence intraoral camera versus those of the visual-tactile assessment method according to modified ICDAS-II criteria in clinical

Study Overview

• Status: Unknown
• Conditions: Caries, Dental
• Intervention / Treatment: Diagnostic test: light induced fluorescence camera

Detailed Description

volunteers patients will be assigned in this study. Each patient should have at least one posterior tooth with pits and fissure discoloration and maximum 4 teeth. The teeth will be evaluated by two diagnostic methods (D), where D1 represents visual-tactile assessment method (ICDAS-II) and D2 represents light induced fluorescence intraoral camera.Three operators, the researcher and the 2 supervisors, from the Conservative Dentistry Department, Faculty of Dentistry, Cairo University, will be the examiners in this study. Each examiner will record the dental findings using both the visual- tactile assessment method and the fluorescent-aided identification method. The visual-tactile assessment method includes the use of mirror, probe under good illumination condition, while the fluorescent-aided identification method will be performed by light induced fluorescence intraoral camera.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: noura alzayyat, phd; Phone Number: 01006454668; Email: noura.alzayyat@hotmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11211
    • Recruiting
    • Dentistry Cairo University
    • Contact: noura alzayyat, phd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients aged from 15 to 50 years.
• No gender restriction.
• Patients should have an acceptable oral hygiene level.
• Patients must have at least one posterior with fissure discoloration

Exclusion Criteria:

• • Patients with a compromised medical history.

  • Severe or active periodontal disease.
  • Heavy bruxism or a traumatic occlusion.
  • Acute or chronic dental infection.
  • Pregnant or breastfeeding women.
  • Patients with posterior restorations on molars or premolars.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: ICDAS-II; According to the international caries detection and assessment system (ICDAS-II). The visual examination was performed using the ICDAS-II criteria, which provides a standardized method of lesion detection. The ICDAS-II detection codes for coronal categories the score will be 0 =surface not restored or sealant then according to caries categories range from 0 to 6 depending on the severity of the lesion with the corresponding clinical views.

Diagnostic test: light induced fluorescence camera; The light induced fluorescence intraoral camera works with a visible blue light frequency (wavelength 450 nm) for the illumination of the dental surface and produces an overlapping image of the green fluorescence image on the image of the white light. The green fluorescence image is considered an indicator of healthy dental tissues. The colour of the fluorescence signal is green when the dentin is healthy. The healthy enamel is blue due to the scattered green light of the dentin, despite the lack of a fluorescence signal. On the other hand, caries can be easily detected by dark red fluorescence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reliability and reproducibility of intra oral light fluorescence camera using kappa strength	in primary caries diagnosis	6 month

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2019
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: June 26, 2018
• First Submitted That Met QC Criteria: July 12, 2018
• First Posted (Actual): July 16, 2018

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 13, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: CEBD-CU-2018-06-30

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