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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03586713
Other study ID # CEBD-CU-2018-06-30
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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