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

NCT ID: NCT03586713

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-31
• Study Completion Date: 2019-05-31

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.

Conditions

Caries, Dental

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

light induced fluorescence camera

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Noura alzayyat

assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dentistry Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

noura alzayyat, phd

Role: CONTACT

noura.alzayyat@hotmail.com

01006454668

Facility Contacts

noura alzayyat, phd

Role: primary

Other Identifiers

CEBD-CU-2018-06-30

Identifier Type: -

Identifier Source: org_study_id