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Is DIAGNOcam Comparable to Bitewing Radiographs as a Diagnostic Method for Approximal Caries in Primary Teeth?

NCT03181711 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2022-04-20

No results posted yet for this study

Summary

BACKGROUND: To diagnose caries in clinical practice today, a combination of clinical examination with mirror and probe, and in sometimes x-ray images are used. For surfaces in contact with other teeth X-rays (preferably bitewing) are often required. Even though the radiation doses in bitewings are small, it is important to weigh risks against the benefit to avoid unnecessary radiation.

There are other methods for diagnosing caries based on different forms of laser light. One such technique is based on the translucency of the teeth. The light is within the near infrared light (NIR) area. A product named DAIGNOcam (diagnostic camera) is using this technology. The light is led in a hand piece held against the tooth. The tooth is illuminated and the caries lesions can be seen like dark spots on a computer monitor screen. The technique is mainly used in adult patients and permanent teeth. However, there is no complete evaluation of how well the technology diagnoses caries in milk teeth. From a radiation hygiene point of view, it is particularly important to reduce the amount of X-rays to young individuals. X-rays are often experienced as difficult by younger children, which leads to poorer diagnostics. It is important to identify early caries in milk teeth as these teeth have thinner enamel and a more "porous" dentin. This may lead to that caries progress much faster thus more difficult to fix. This in turn leads to a risk of toothache and that the damage becomes so extensive that the tooth must be removed.

OBJECTIVE: To investigate diagnostic accuracy / precision in caries diagnosis between teeth using DIAGNOcam in milk teeth comparable to caries diagnostics using bitewing x-rays.

RESEARCH QUESTIONS:

* Is DIAGNOcam a reliable diagnostic method for diagnosing caries in between teeth (approximal caries) in milk teeth?
* How does child experience caries diagnosing performed with DIAGNOcam compared to X-rays? INVESTIGATION VARIABLES: Caries data are recorded according to the accepted diagnostic method at the surface level. Each examined tooth surface is assessed as either 1) intact; 2) caries only in enamel; 3) caries i dentin; or 4) the surface can not be judged. The same classification is used for X-rays and DIAGNOcam.

The children will also be able to rate their experience of the X-ray examination and the DIAGNOcam survey using a Faces pain scale to see if there is any difference in experience between the different methods of investigation.

Conditions

  • Caries

Sponsors & Collaborators

  • Malmö University

    lead OTHER

Principal Investigators

  • Susanne I Brogårdh-Roth, Doctor · Malmö University

Eligibility

Min Age
4 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2022-01-01
Completion
2022-04-01

Countries

  • Sweden

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 NCT03181711 on ClinicalTrials.gov