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

Cairo University (CU)

Status: Completed

Conditions: Dental Caries (Diagnosis)

Study type: Observational

Funder types: Other

Identifiers

NCT06790485

24-058

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 1 patient group

patient with initial occlusal caries