Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03181711 |
| Other study ID # |
DIAGNOcam Malmo U |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2017 |
| Est. completion date |
April 1, 2022 |
Study information
| Verified date |
April 2022 |
| Source |
Malmö University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
