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

Not Applicable

• Conditions: Caries, Dental
• Interventions: Diagnostic Test: light induced fluorescence camera

• Registration Number: NCT03586713
• Lead Sponsor: Cairo University

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-06-26
• Study First Submitted QC: 2018-07-12
• Study First Posted: 2018-07-16
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-13
• Last Update Posted: 2019-02-15
• Study Start: 2019-05
• Primary Completion: 2019-05
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICDAS-II	light induced fluorescence camera	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.

Primary Outcome Measures

Name	Time	Method
reliability and reproducibility of intra oral light fluorescence camera using kappa strength	6 month	in primary caries diagnosis

Trial Locations

Locations (1)

Dentistry Cairo University; 🇪🇬 Cairo, Egypt