Clinical trial NCT06790485: In-Vivo Validation of Novel Diagnostic Devices Versus Visual ICDAS-II Criteria in Detection of Early Occlusal Caries
Official title: In-Vivo Validation of Novel Diagnostic Devices Versus Visual ICDAS-II Criteria in Detection of Early Occlusal Caries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Caries (Diagnosis)
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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

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.


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

Primary outcomes:
measure: primary occlusal caries
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: The British University in Egypt
state: Other
Study officials:
References:
citation: 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.