Diagnostic Accuracy of a Bioluminescence System for the Assessment of Caries Activity on Occlusal Surfaces

Jablonski-Momeni, Anahita; Moos, Johanna; Manesh, Vahid Sakhaei; Stoll, Norbert

doi:10.1159/000486139

Cited by 12 publications

(17 citation statements)

References 21 publications

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“…In the present in vivo study, a bioluminescence device (Calcivis imaging System, Cis) was used to monitor the occlusal surfaces of permanent teeth, and the findings were compared with visual assessments based on ICCMS criteria for lesion activity assessment [17]. The Cis measurements were not significantly different from the values obtained in the visual assessment, confirming the results of previous in vitro studies [7].…”

Section: Discussionsupporting

confidence: 77%

“…A sample size calculation was performed using the software PASS 11, NCSS, version 11.0.7 (Kaysville, UT, USA), based on data of a preliminary in vitro study assessing the agreement between visual and bioluminescence measurements and diagnostic accuracy of activity assessment [7]. A total of 48 occlusal surfaces were calculated for a power of 0.95 and α = 0.05.…”

Section: Sample Size Calculationmentioning

confidence: 99%

“…Such luminescence areas are typically present as blue spots, demonstrating the presence of demineralized surfaces. In a preliminary study on occlusal caries lesions, the bioluminescence system demonstrated high reproducibility and good diagnostic accuracy values for the assessment of active caries lesions in vitro based on histological findings [7]. Moreover, the ability of the bioluminescence technology to identify demineralization on smooth surfaces adjacent to orthodontic brackets was shown [8].…”

Section: Introductionmentioning

confidence: 99%

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Agreement of Bioluminescence Measurements and Visual Assessment in Monitoring Occlusal Surfaces of Permanent Teeth

Jablonski-Momeni

Jablonski²,

Heinzel‐Gutenbrunner

et al. 2022

JCM

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Background: Caries lesion activity is typically assessed by visual–tactile criteria. Regular monitoring is required to detect the transition of lesions and to ensure that the initial assessment was valid. This clinical study aimed to evaluate the agreement of bioluminescence measurements (Calcivis imaging system, Cis) with visual examination to assess caries lesion activity and to monitor occlusal surfaces. Methods: The occlusal surfaces of ninety-one permanent posterior teeth were assessed for the presence or absence of active caries lesions with ICCMS criteria and Cis measurements at three visit times: baseline (t1) and six months (t2) and 12 months (t3) after baseline. Results: At the baseline visit, 70% of the included occlusal sites were assessed visually as active lesions (ICCMS codes 1 and 2). At t3, 64.8% of the sites showed signs of an active lesion. The percentage agreements between the visual and Cis methods were 87.8% (t1), 89.9% (t2) and 88.6% (t3). The corresponding κ-values were 0.71 (95% CI 0.52;0.87), 0.75 (95% CI 0.59;0.89) and 0.77 (95% CI 0.61;0.90), respectively. No significant difference between the visual and bioluminescence systems was found at any visit (p > 0.05). The results based on cluster randomization (generalized estimation equations) showed no significant differences between the visual and Cis findings for all visits (p = 0.108, Wald Χ2 with 1 df = 2.587). Conclusion: The bioluminescence system demonstrated substantial agreement for the activity assessment of occlusal lesions compared to the findings obtained by visual assessment over twelve months.

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Section: Discussionsupporting

confidence: 77%

Section: Sample Size Calculationmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Agreement of Bioluminescence Measurements and Visual Assessment in Monitoring Occlusal Surfaces of Permanent Teeth

Jablonski-Momeni

Jablonski²,

Heinzel‐Gutenbrunner

et al. 2022

JCM

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“…A novel bioluminescence technology, the CALCIVIS Imaging System, has been developed to aid in the assessment of caries lesion activity. An in vitro study on occlusal sites of extracted teeth, using a pH dye for validation of activity, demonstrated: (a) a sensitivity of 92.5%; (b) a specificity of 90%, and (c) a diagnostic accuracy for activity assessment of caries lesions which was not significantly different from the value obtained using the ICDAS activity assessment method (Jablonski-Momeni et al, 2018), which was the validated activity assessment method used in the current article-vide infra. The technology underlying the CALCIVIS imaging system was developed to help address this unmet need.…”

Section: Introductionmentioning

confidence: 71%

Clinical validation of a novel bioluminescence imaging technology for aiding the assessment of carious lesion activity status

Pitts

Shanks

Longbottom

et al. 2021

Clinical & Exp Dental Res

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Objectives: Clinical validation of a bioluminescence imaging system (Cis) as measured by the level of agreement between clinician visual and tactile assessment of carious lesion presence and activity and the presence/absence of elevated luminescence on a tooth surface determined from intraoral image mapping. Materials and Methods:This was a regulatory clinical study designed in consultation with the FDA. The design was a prospective, five-investigator, nonrandomized, postapproval, clinical study utilizing the Cis to provide images of elevated calcium ion concentration (indicative of active demineralization) on tooth surfaces via use of a photoprotein. Imaged teeth were identified as "sound" or having "active lesions."Images were scored independently for luminescence.Results: A total of 110 participants aged 7-74 years were imaged. Of the 90 teeth assessed as "sound," 88 were deemed to show no luminescence by the reviewing investigator, a negative percentage agreement of 97.8% (significantly >50% agreement [p < .0001]; one-sided 97.5% confidence interval [CI]: 0.9220). Of the 86 teeth initially assessed as having an "active lesion," 78 were deemed to show luminescence by the reviewing investigator, a positive percentage agreement of 90.7% (significantly >50% agreement [p < .0001]; 97.5% CI: 0.8249). There were no patientrelated adverse events.Conclusions: Results show, with a high level of agreement, that Cis can differentiate tooth surfaces clinically identified as involving active enamel lesions (ICDAS code 2/3), from sound sites (biochemically equivalent to inactive lesions) and that the system is safe for clinical use.

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“…Another study showed lower sensitivity and specificity values for the bioluminescence system compared to the fluorescence-based system when active initial lesions were detected on occlusal surfaces [8]. However, the results were based on visual assessment of the teeth as a reference, so that the results cannot be compared to the study by Jablonski-Momeni et al [17] due to the lack of histological findings. Longbottom et al [19] used the bioluminescence technology for assessment of artificially produced demineralization in dental enamel at different pH values such as acidic solutions.…”

Section: Discussionmentioning

confidence: 96%

Einsatz eines Biolumineszenzverfahrens zur Detektion artifiziell erzeugter Demineralisationen an der Bracketzirkumferenz

et al. 2021

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Purpose Enamel demineralization can occur as a side effect during orthodontic treatment with fixed appliances and should be detected as early as possible. A new approach to assess demineralization is a system consisting of a photosensitive protein that binds to free calcium ions at the enamel surface. A camera is then used to visualize the bioluminescence spots. This in vitro study aimed to evaluate the ability of the bioluminescence technology to assess artificially demineralized enamel adjacent to various orthodontic brackets. Methods In all, 108 human enamel samples were allocated randomly to groups with different orthodontic bracket material: stainless steel, titanium, ceramic. Initial lesions were created adjacent to the brackets. The samples were assessed by bioluminescence before and after demineralization. Images were assessed for presence of bioluminescence spots (yes/no). To quantify the bioluminescence measurements, the images’ pixel values (P) were calculated within a defined area (F) adjacent to each bracket before and after demineralization. Quantitative light-induced fluorescence measurements (ΔF, ΔQ) were performed as the reference standard for demineralization. Results After demineralization, bioluminescence spots were visible (yes/no decision) in 87% of the samples. The pixel analysis of the bioluminescence spots showed significantly higher pixel values after demineralization compared to baseline (p < 0.0001). The bracket material had no influence on the bioluminescence measurements. All samples showed fluorescence loss with a median ΔF of −9.52% (±3.15) and a median ΔQ of −1.01% × mm2 (±3.34), respectively. Conclusion The bioluminescence technology is a promising tool to demonstrate demineralization adjacent to different orthodontic brackets in vitro.

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Diagnostic Accuracy of a Bioluminescence System for the Assessment of Caries Activity on Occlusal Surfaces

Cited by 12 publications

References 21 publications

Agreement of Bioluminescence Measurements and Visual Assessment in Monitoring Occlusal Surfaces of Permanent Teeth

Agreement of Bioluminescence Measurements and Visual Assessment in Monitoring Occlusal Surfaces of Permanent Teeth

Clinical validation of a novel bioluminescence imaging technology for aiding the assessment of carious lesion activity status

Einsatz eines Biolumineszenzverfahrens zur Detektion artifiziell erzeugter Demineralisationen an der Bracketzirkumferenz

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