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

NCT06790485 | Completed

• 1 other identifier: 24-058
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• primary occlusal caries

  posterior tooth with occlusal discoloration

  1 week

Study Arms (1)

patient with initial occlusal caries

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients will be recruited by researcher according to the eligibility criteria from clinic of conservative dentistry department in Faculty of Dentistry in The British University in Egypt, where there is a continuous and high patient flow

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

The British University in Egypt

Cairo, Other, 223453, Egypt

Location

Related Publications (1)

• 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.

  PMID: 36755680 BACKGROUND

MeSH Terms

Conditions

Dental Caries; Disease

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Conservative Dentistry

Study Record Dates

• First Submitted: January 18, 2025
• First Posted: January 24, 2025
• Study Start: August 20, 2024
• Primary Completion: October 24, 2024
• Study Completion: November 24, 2024
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

EG (1)