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

NCT03586713 | Unknown DMC

• 1 other identifier: CEBD-CU-2018-06-30
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Caries, Dental

Outcome Measures

Primary Outcomes (1)

• reliability and reproducibility of intra oral light fluorescence camera using kappa strength

  in primary caries diagnosis

  6 month

Study Arms (1)

ICDAS-II

OTHER

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

Interventions

light induced fluorescence camera 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.

ICDAS-II

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Dentistry Cairo University

Cairo, 11211, Egypt

RECRUITING

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

noura alzayyat, phd

CONTACT

01006454668; noura.alzayyat@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Model Details: 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 made

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 16, 2018
• Study Start: May 1, 2019
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

EG (1)