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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Near infrared transillumination | Active Comparator | Near infrared transillumination is applied for initial enamel caries lesion detection. |
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| Visual caries detection + BW | Active Comparator | visual caries detection + bite wing radiography (BW): considered as gold standard in caries diagnostics. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non invasive caries treatment | Other | If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion Activity | active lesions: 1; inactive lesions: 0 | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Klaus W Neuhaus, PD | Department of Preventive, Restorative and Pediatric Dentistry, University of Bern | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | 35 participants with either initial caries and/or no carious lesion were included in this study. The participants had to be at least 14 years old, in good health (ASA-Status 1) and they had to give their informed consent. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Invasive caries treatment | Other | If the active comparator does detect cavitation, a composite restauration is placed |
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| Near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany) | Device |
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| Visual examination and bitewing (BW) radiography | Other | established diagnostic methods |
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| Received Near Infrared Transillumination |
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| Received Visual Caries Detection + Bite |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | 35 participants with either initial caries and/or no carious lesion were included in this study. The participants had to be at least 14 years old, in good health (ASA-Status 1) and they had to give their informed consent. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | 95% Confidence Interval | weighted Kappa | One year | Teeth/ Leasons | Participants |
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| Secondary | Lesion Activity | active lesions: 1; inactive lesions: 0 | The data were not collected and the Outcome will never be analyzed because of the study population. The participants are all low risk in the analysis of caries, with low amount of gingivitis and good oral hygiene what means that no progression/ change in caries activity will be detectable in any patient. So it doesn't make sense to analyze it. | Posted | One year |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Near Infrared Transillumination | Near infrared transillumination is applied for initial enamel caries lesion detection. Non invasive caries treatment: If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface. Invasive caries treatment: If the active comparator does detect cavitation, a composite restauration is placed Near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany) | 0 | 35 | 0 | 35 | ||
| EG001 | Visual Caries Detection + BW | visual caries detection + bite wing radiography (BW): considered as gold standard in caries diagnostics. Non invasive caries treatment: If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface. Invasive caries treatment: If the active comparator does detect cavitation, a composite restauration is placed Visual examination and bitewing (BW) radiography: established diagnostic methods | 0 | 35 | 0 | 35 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PD Dr. Klaus Neuhaus | Department of Preventive, Restorative and Pediatric Dentistry, University of Bern | +41 (0)31 632 49 74 | klaus.neuhaus@zmk.unibe.ch |
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D005457 | Fluoridation |
| D019370 | Observation |
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D011313 | Preventive Dentistry |
| D003813 | Dentistry |
| D011636 | Public Health Dentistry |
| D004778 | Environment and Public Health |
| D008722 | Methods |
| D008919 | Investigative Techniques |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
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| Inter-rater agreement |
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