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Diagnostic Ability of Near Infrared Transillumination Detecting Interproximal Caries as Compared to Conventional Bitewing Radiographs

NCT05362461 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2022-11-01

No results posted yet for this study

Summary

Specific Aims

1. To determine the diagnostic efficacy of CariVu and BWX for detecting interproximal carious lesions in primary dentition

BWX and CariVu images will be taken in random order. Number and depth of interproximal carious lesions will be determined by two independent examiners using both CariVu images and BWX. Intra- and inter-rater agreement and disagreement will be determined for all the images and radiographs.
2. To determine acceptability and comfort of CariVu and BWX as perceived by patient, parent and independent observer

BWX and CariVu images will be taken in a random order and patient and parent will be given a questionnaire to complete as exit survey. The questionnaire will include few questions to determine perceived acceptability and comfort by parent and patient for either methods (CariVu and BWX). An independent observer (dental assistant) who is masked for the hypothesis of the study will be given a similar questionnaire to evaluate patient behavior using standard behavior assessment scales.
3. To determine difference in chair-side time required for BWX and CariVu image generation

Time required to generate both, BWX and CariVu images will be documented by an independent observer (dental assistant) who is masked for the hypothesis of the study and will be compared to determine the overall clinical chair-side time required for generating diagnostic images for efficient and accurate treatment planning

Conditions

  • Caries,Dental

Interventions

DIAGNOSTIC_TEST

Near Infrared Transillumination

Caries imaging detection technology.

Sponsors & Collaborators

  • Children's Hospital Colorado

    collaborator OTHER

  • University of Colorado, Denver

    lead OTHER

Eligibility

Min Age
5 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2022-12-31
Completion
2023-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05362461 on ClinicalTrials.gov