In-Vivo Validation of Novel Diagnostic Devices Versus Visual ICDAS-II Criteria in Detection of Early Occlusal Caries

NCT ID: NCT06790485

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-20
• Study Completion Date: 2024-11-24

Brief Summary

The diagnosis of non-cavitated occlusal caries is considered problematic and still a challenge for dental professionals. It affects 60-90% of schoolchildren and adults.Clinically, caries commonly is performed by methods of visual examination and subjective assessments of, translucency, color and dental hardness, as well as by means of radiographic imaging. These methods, however, show low sensitivity for occlusal caries detection.Some of these methods are light based fluorescence devices taking the advantages of the fluorescence properties of the hard tissues of the tooth as there is a difference in fluorescence observed in sound and demineralized dental tissues.Other methods based on electrical impedance has been used. These devices aimed to employ the AC Impedance Spectroscopy Technique (ACIST) In order to record variations in mineral density throughout the tooth, not just the surface, ACIST sends a low amplitude microamp current from the sensor tip contact through the pulp, dentin, and enamel.Hence, a diagnostic accuracy study control trial is to be held to evaluate the Clinical performance of quantitative light fluorescence based device (Vistacam Proof) and impedance spectroscopy based device (CariescanPRO) in comparison with the visual examination and digital radiography in detection of initial pits and fissures caries.

Conditions

Dental Caries (Diagnosis)

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Study Groups

patient with initial occlusal caries

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients aged from 21 to 50 years.

• Patient at least has one posterior pits and fissure occlusal caries.
• No gender restriction
• Co-operative patients who signed the informed consent.
• Good general health
• Acceptable oral health

Exclusion Criteria

• Pregnancy.

• Disabilities.
• Systemic disease or severe medical complications.
• Allergic history concerning methacrylate.
• Rampant caries.
• Heavy smoking.
• Xerostomia.
• Lack of compliance.
• Evidence of severe bruxism, clenching, or temporomandibular joint disorders

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Amr Abdel Fattah Mahmoud Edrees

Assistant Professor of Conservative Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The British University in Egypt

Cairo, Other, Egypt

Countries

Egypt

References

Edrees A, Hassanein O, Shaalan O, Yassen A. Accuracy of high definition near infrared transillumination camera in detection of hidden proximal caries. J Clin Exp Dent. 2023 Jan 1;15(1):e1-e8. doi: 10.4317/jced.59413. eCollection 2023 Jan.

Reference Type: BACKGROUND

PMID: 36755680 (View on PubMed)

Other Identifiers

24-058

Identifier Type: -

Identifier Source: org_study_id