Dental CariesNCT02657538
Validation of Near-infrared Light Transillumination for Interproximal Enamel Caries Detection
A study testing Non invasive caries treatment, Invasive caries treatment and Near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany) in people with Dental Caries, run by University of Bern.
Trial summary
The aim of this study is to validate a near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany) for interproximal enamel caries detection and compare it with the established diagnostic methods (visual examination and bitewing radiography). Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Non invasive caries treatment, Invasive caries treatment and Near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ASA-Status 1
- Complete permanent dentition
- Bitewing radiography already existing (< 4 months)
- Minimum of one cavitation-free approximal surface, symptomless, interproximal enamel or dentin caries lesion in the posterior teeth without restorations and/or sound tooth surface.
Who cannot join
- Children younger than 15 Years
About this study
Official title: Validation of Near-infrared Light Transillumination for Interproximal Enamel Caries Detection: A Clinical Controlled Trial
The aim of this study is to validate a near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany) for interproximal enamel caries detection and compare it with the established diagnostic methods (visual examination and bitewing radiography). The aim is to avoid/reduce ionizing radiation for caries diagnostic purposes.
- Conditions
- Dental Caries
- Being tested
- Non invasive caries treatment, Invasive caries treatment, Near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany), Visual examination and bitewing (BW) radiography
- Keywords
- Interproximal caries, Enamel caries, Caries detection, Caries diagnostics, Near-infrared light transillumination, DIAGNOcam
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non invasive caries treatmentOther
Also called Fluoridation
If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface.
Invasive caries treatmentOther
Also called Filling
If the active comparator does detect cavitation, a composite restauration is placed
Near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany)Device
Visual examination and bitewing (BW) radiographyOther
established diagnostic methods
| Study group | Role | What they receive |
|---|---|---|
| Near infrared transillumination | Active comparator | Near infrared transillumination is applied for initial enamel caries lesion detection. Receives: Other: Non invasive caries treatment; Other: Invasive caries treatment; Device: Near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany) |
| Visual caries detection + BW | Active comparator | visual caries detection + bite wing radiography (BW): considered as gold standard in caries diagnostics. Receives: Other: Non invasive caries treatment; Other: Invasive caries treatment; Other: Visual examination and bitewing (BW) radiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries Extension According to Diagnocam Codes 0-4 (Intra- and Interrater-Reliability, Sensitivity and Specificity)
The geometrical shape of caries lesions is displayed with the near infrared transillumination method. These shapes are classified as: code 0: no lesion visible; code 1: first visible signs in enamel; code 2: established, clear visible signs in enamel; code 3: clear visible in enamel and punctual contact with dentine; code 4: clearly visible and broad contact with dentine
Intra- and Interrater-Reliability: Reliability indicates the overall consistency of a measurement. To have a high reliability means in this case, that the diagnostic-tool produces similar results under consistent conditions. The interrater-Reability assesses the degree of agreement between two different raters in their diagnostics on a specific test while the intrarater-Reliability assesses the degree of agreement of a single rater who did a diagnostic-test twice under the same testing conditions.
Sensitivity and Specificity: Statistics are not done yet but will be updated when we calculated them
Measured: One year
Secondary outcomes (1)
Lesion Activity
active lesions: 1; inactive lesions: 0
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study startJul 2014
- Primary completionDec 2014
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Klaus W Neuhaus, PD, Principal investigator, Department of Preventive, Restorative and Pediatric Dentistry, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657538
- Sponsor's protocol ID
- 110/13
- Status last verified
- Jul 2016
- First submitted
- 5 Jan 2016
- Last updated
- 18 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Near-infrared Light Transillumination for Interproximal Enamel Caries Detection: A Clinical Controlled Trial
- ClinicalTrials.gov ID
- NCT02657538
- Acronym / sponsor ID
- 110/13
- Conditions
- Dental Caries
- Keywords
- Interproximal caries, Enamel caries, Caries detection, Caries diagnostics, Near-infrared light transillumination, DIAGNOcam
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 18 Jan 2016 (estimated)
- Results
- Posted 18 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to validate a near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany) for interproximal enamel caries detection and compare it with the established diagnostic methods (visual examination and bitewing radiography). The aim is to avoid/reduce ionizing radiation for caries diagnostic purposes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Near infrared transillumination | Active comparator | Other: Non invasive caries treatment, Other: Invasive caries treatment, Device: Near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany)Near infrared transillumination is applied for initial enamel caries lesion detection. |
| Visual caries detection + BW | Active comparator | Other: Non invasive caries treatment, Other: Invasive caries treatment, Other: Visual examination and bitewing (BW) radiographyvisual caries detection + bite wing radiography (BW): considered as gold standard in caries diagnostics. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- ASA-Status 1
- Complete permanent dentition
- Bitewing radiography already existing (< 4 months)
- Minimum of one cavitation-free approximal surface, symptomless, interproximal enamel or dentin caries lesion in the posterior teeth without restorations and/or sound tooth surface.
Key exclusion criteria (1 listed)
- Children younger than 15 Years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non invasive caries treatmentAlso: FluoridationIf the active comparator does not detect cavitation, fluoride varnish is applied on the test surface. | Other | Near infrared transillumination, Visual caries detection + BW |
| Invasive caries treatmentAlso: FillingIf the active comparator does detect cavitation, a composite restauration is placed | Other | Near infrared transillumination, Visual caries detection + BW |
| Near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany) | Device | Near infrared transillumination |
| Visual examination and bitewing (BW) radiographyestablished diagnostic methods | Other | Visual caries detection + BW |
Primary outcome
Caries Extension According to Diagnocam Codes 0-4 (Intra- and Interrater-Reliability, Sensitivity and Specificity)
Time frame: One year
The geometrical shape of caries lesions is displayed with the near infrared transillumination method. These shapes are classified as: code 0: no lesion visible; code 1: first visible signs in enamel; code 2: established, clear visible signs in enamel; code 3: clear visible in enamel and punctual contact with dentine; code 4: clearly visible and broad contact with dentine Intra- and Interrater-Reliability: Reliability indicates the overall consistency of a measurement. To have a high reliability means in this case, that the diagnostic-tool produces similar results under consistent conditions. The interrater-Reability assesses the degree of agreement between two different raters in their diagnostics on a specific test while the intrarater-Reliability assesses the degree of agreement of a single rater who did a diagnostic-test twice under the same testing conditions. Sensitivity and Specificity: Statistics are not done yet but will be updated when we calculated them
1 secondary outcome
Lesion Activity
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Klaus W Neuhaus, PD principal investigator
Department of Preventive, Restorative and Pediatric Dentistry, University of Bern
Questions about this trial
What is this clinical trial studying?
A study testing Non invasive caries treatment, Invasive caries treatment and Near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany) in people with Dental Caries, run by University of Bern.
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 1 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 18 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 18 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Caries Extension According to Diagnocam Codes 0-4 (Intra- and Interrater-Reliability, Sensitivity and Specificity) (time frame: One year). 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 18 Aug 2016.