CariesDiagncameraNCT03181711
Is DIAGNOcam Comparable to Bitewing Radiographs as a Diagnostic Method for Approximal Caries in Primary Teeth?
An observational study of Caries, run by Malmö University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Caries
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2017to 1 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Children aged 4-8
- Radiograph bitewings not older than 3 months
- First and second primary mandibular or maxillary molars present
- Parental consent
Who cannot join
- Children not in need of bitewing radiographs
- Children with mineralization disturbances, chronic diseases, functional or psychological disabilities that influence the possibility to participate
- Children who of other reasons have difficulties to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Between DIAGNOcam and Bitewing Radiographs as Diagnostic Methods for Approximal Caries in Primary Teeth.
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.
Read more
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.
Read the 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.
- Conditions
- Caries
- Keywords
- Dental caries, Tooth, deciduous, Children, Radiography/bitewing, diagnostic imaging
- Medical subject headings
- Dental Caries
What is being measured
The primary outcome is the main question the study is designed to answer.
number of surfaces with manifest approximal caries lesions
approximal caries in primary molars registered in radiographs (bitewings) or with DIAGNOcam. Caries lesions clearly visible in dentin.
Measured: measured at the dental examination
Secondary outcomes (1)
Children´s perception of pain during examination with radiographs (bitewings) and DIAGNOcam.
Child assessment of pain using Facial Pain Scale
Measured: measured at the dental examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start1 Jun 2017
- Primary completion1 Jan 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malmö University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susanne Brogårdh-Roth, Malmö University
- Investigators
- Susanne I Brogårdh-Roth, Doctor, Principal investigator, Malmö University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181711
- Sponsor's protocol ID
- DIAGNOcam Malmo U
- Acronym
- Diagncamera
- Status last verified
- Apr 2022
- First submitted
- 4 Jun 2017
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between DIAGNOcam and Bitewing Radiographs as Diagnostic Methods for Approximal Caries in Primary Teeth.
- ClinicalTrials.gov ID
- NCT03181711
- Acronym / sponsor ID
- Diagncamera / DIAGNOcam Malmo U
- Conditions
- Caries
- Keywords
- Dental caries, Tooth, deciduous, Children, Radiography/bitewing, diagnostic imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Malmö UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 9 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- Children aged 4-8
- Radiograph bitewings not older than 3 months
- First and second primary mandibular or maxillary molars present
- Parental consent
Key exclusion criteria (3 listed)
- Children not in need of bitewing radiographs
- Children with mineralization disturbances, chronic diseases, functional or psychological disabilities that influence the possibility to participate
- Children who of other reasons have difficulties to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of surfaces with manifest approximal caries lesions
Time frame: measured at the dental examination
approximal caries in primary molars registered in radiographs (bitewings) or with DIAGNOcam. Caries lesions clearly visible in dentin.
1 secondary outcome
Children´s perception of pain during examination with radiographs (bitewings) and DIAGNOcam.
Time frame: measured at the dental examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne I Brogårdh-Roth, Doctor principal investigator
Malmö University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caries, run by Malmö University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of surfaces with manifest approximal caries lesions (time frame: measured at the dental examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.