Is DIAGNOcam Comparable to Bitewing Radiographs as a Diagnostic Method for Approximal Caries in Primary Teeth?
Condition: Caries
Study type: Observational

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.
    

Detailed description: 
      BACKGROUND: Caries is a multifactorial and infectious disease. To diagnose caries in clinical
      practice, a combination of clinical examination with mirror and probe (visual-tactile
      examination) is used today, as well as in some cases standardized x-rays called bitewing
      x-ray (bw). Visual-tactile examination is enough to diagnose caries on buccal and
      lingual/palate surfaces. However, for approximal surfaces, X-rays are often required to
      ensure diagnosis and to assess the spread of a caries lesion in the tooth. Bitewing X-rays
      are the single best diagnostic tools for diagnosing caries in approximal surfaces. An X-ray
      examination should always be performed on individual indications. At bw the radiation doses
      are small. Nevertheless, it is important to weigh risks against the benefit to avoid
      unnecessary radiation. Reducing the number of dental radiographs is also important from the
      perspective of safe dental care where one strives to make use of and not harm.

      There are other methods for diagnosing caries based on different forms of laser light that
      can detect caries. Previously, these techniques have only been used for occlusal surfaces and
      buccal/lingual/palate tooth surfaces, not for diagnostics between teeth. For some time now,
      the translucency of the teeth is used in a technique. The light is within the so-called NIR
      area - near infrared light (non-wavelength wavelength). On the market, a product (DAIGNOcam)
      uses this technology. The light is led in a hand piece (like a little bigger pen) held
      against the tooth, one tooth at a time. The tooth is illuminated and a digital video camera
      on the hand piece projects a computer monitor image. In the picture, the caries lesions are
      seen like dark spots. These correspond to a qualitative defect in the enamel or dentin, i.e.
      an area where various minerals were lost / dissolved due to caries (demineralized area). The
      image can be saved in the patient's dental record in the same way as regular photos or
      X-rays. DIAGNOcam provides a qualitative response - one looks primarily if it is caries or
      not. It will then be a supplement to the usual survey with mirror and probe. The technique is
      mainly used in adult patients and permanent teeth. DIAGNOcam is currently available in
      clinical practice since a number of years. However, there is no complete evaluation of how
      well the technology diagnoses caries in primary teeth. This is unfortunate for mainly two
      reasons: from a radiation hygiene point of view, it is especially important to reduce the
      amount of X-rays to young individuals; Intra-oral X-rays are often experienced as difficult
      to manage by younger children, which leads to poorer diagnostics. It is important to identify
      early caries lesions in primary teeth as these teeth have a thinner enamel and a less
      mineralized dentin, which causes a caries lesion to progress much faster. This may lead to
      difficulties in restoring the teeth as well as pain from pulpal involvement. If the carious
      lesion is extensive, this may lead to tooth extraction.

      OBJECTIVE: To investigate diagnostic accuracy / precision in caries diagnostics using
      DIAGNOcam in primary teeth comparable to caries diagnostics using bitewing x-rays.

      PRIMARY RESEARCH QUESTION:

      • Is DIAGNOcam a reliable diagnostic method for diagnosing approximal caries in primary
      teeth?

      SECONDARY RESEARCH QUESTION:

      • How does children experience caries diagnosing performed with DIAGNOcam compared to X-rays?
      INVESTIGATION VARIABLES: Caries data are recorded according to the standardized diagnostic
      method at surface level (dental sites with approximal contacts). Each examined tooth surface
      is assessed as either 1) intact; 2) caries only in enamel; 3) caries i dentin; or 4) the
      surface cannot 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.

      KNOWLEDGE GAINS: New methods should always be evaluated before implementation to ensure good
      care. There are no evaluated diagnostic methods that do not use ionised radiation (X-ray) for
      caries diagnosing of approximal surfaces in contact with another tooth. If DIAGNOcam in
      evaluation shows the same diagnostic accuracy as X-ray, this may reduce the use of dental
      x-ray for children. If DIAGNOcam is found to have poorer diagnostic accuracy, the method
      should be avoided as a caries diagnostic method in primary teeth. The latter is based on the
      fact that children should not be exposed to unnecessary examinations or interventions that do
      not result in health benefits.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        50 patients who meet the inclusion criteria are recruited consecutively at the dep of
        pediatric dentistry, Faculty of Odontology in Malmö. In order to obtain a spread in caries,
        there are no restraints regarding dental health in the children. It is important to include
        both children with a lot of caries and children with little or even no caries.

        No power calculation can be performed as there is no basis for obtaining the size of the
        study population. However, there are similar studies on other diagnostic methods in which
        diagnostic reliability was investigated with a study material of 50 patients. Therefore,
        the study intends to include 50 patients resulting in at least 400 surfaces.
      
Keywords: Dental caries; Tooth, deciduous; Children; Radiography/bitewing; diagnostic imaging