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

Sponsor

Cairo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03586713

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Caries, Dental	Diagnostic Test: light induced fluorescence camera	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Screening of patients that come to the conservative dentistry department seeking dental care will continue until the target population is achieved. The patients' teeth will be subjected to visual examination and diagnosis using dental charts. Once the patients that are potentially eligible for this study are identified, they will be contacted by the research investigator who will explain the study and ascertains the patient's interest. If interested, more detailed evaluations and preparations are madeScreening of patients that come to the conservative dentistry department seeking dental care will continue until the target population is achieved. The patients' teeth will be subjected to visual examination and diagnosis using dental charts. Once the patients that are potentially eligible for this study are identified, they will be contacted by the research investigator who will explain the study and ascertains the patient's interest. If interested, more detailed evaluations and preparations are made

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Anticipated Study Start Date :

May 1, 2019

Anticipated Primary Completion Date :

May 1, 2019

Anticipated Study Completion Date :

May 1, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

reliability and reproducibility of intra oral light fluorescence camera using kappa strength [6 month]
in primary caries diagnosis

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dentistry Cairo University	Cairo		Egypt	11211

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Noura alzayyat, assistant lecturer, Cairo University

ClinicalTrials.gov Identifier:

NCT03586713

Other Study ID Numbers:

CEBD-CU-2018-06-30

First Posted:

Jul 16, 2018

Last Update Posted:

Feb 15, 2019

Last Verified:

Feb 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dental Caries

Study Results

No Results Posted as of Feb 15, 2019