Dental Caries
Conditions
Keywords
Interproximal caries, Enamel caries, Caries detection, Caries diagnostics, Near-infrared light transillumination, DIAGNOcam
Brief 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). The aim is to avoid/reduce ionizing radiation for caries diagnostic purposes.
Interventions
OTHERNon invasive caries treatment
If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface.
OTHERInvasive caries treatment
If the active comparator does detect cavitation, a composite restauration is placed
DEVICENear-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany)
OTHERVisual examination and bitewing (BW) radiography
established diagnostic methods
Sponsors
University of Bern
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* Children younger than 15 Years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caries Extension According to Diagnocam Codes 0-4 (Intra- and Interrater-Reliability, Sensitivity and Specificity) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lesion Activity | One year | active lesions: 1; inactive lesions: 0 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants |
| Age, Continuous | 27.5 years |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
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
Time frame: One year
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Near Infrared Transillumination | Caries Extension According to Diagnocam Codes 0-4 (Intra- and Interrater-Reliability, Sensitivity and Specificity) | Intra-rater agreement examiner 1 | 0.68 weighted Kappa |
| Near Infrared Transillumination | Caries Extension According to Diagnocam Codes 0-4 (Intra- and Interrater-Reliability, Sensitivity and Specificity) | Intra-rater agreement examiner 2 | 0.62 weighted Kappa |
| Near Infrared Transillumination | Caries Extension According to Diagnocam Codes 0-4 (Intra- and Interrater-Reliability, Sensitivity and Specificity) | Inter-rater agreement | 0.42 weighted Kappa |
| Visual Caries Detection + BW | Caries Extension According to Diagnocam Codes 0-4 (Intra- and Interrater-Reliability, Sensitivity and Specificity) | Intra-rater agreement examiner 1 | 0.87 weighted Kappa |
| Visual Caries Detection + BW | Caries Extension According to Diagnocam Codes 0-4 (Intra- and Interrater-Reliability, Sensitivity and Specificity) | Intra-rater agreement examiner 2 | 0.76 weighted Kappa |
| Visual Caries Detection + BW | Caries Extension According to Diagnocam Codes 0-4 (Intra- and Interrater-Reliability, Sensitivity and Specificity) | Inter-rater agreement | 0.60 weighted Kappa |
Secondary
Lesion Activity
active lesions: 1; inactive lesions: 0
Time frame: One year
Population: 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.