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

Caries, Dental Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03586713
• Other study ID #: CEBD-CU-2018-06-30
• Status: Recruiting
• Phase: N/A
• Start date: May 2019
• Est. completion date: May 2019

Study information

• Verified date: February 2019
• Source: Cairo University
• Contact: noura alzayyat, phd
• Phone: 01006454668
• Email: noura.alzayyat[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caries, Dental
• Dental Caries

Intervention

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.

Locations

Country	Name	City	State
Egypt	Dentistry Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reliability and reproducibility of intra oral light fluorescence camera using kappa strength	in primary caries diagnosis	6 month