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Diagnostic performance of a point-of-care test device for periodontitis using human saliva: a single-center, single-blinded, confirmatory study

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Abstract

Objective

Recently, matrix metalloproteinase-8 (MMP-8) has been used to diagnose periodontal disease in a point-of-care (POC) test in order to save time and cost relative to the traditional diagnostic workflow. This study aimed to investigate the diagnostic performance of INCLIX TRF MMP-8, a POC testing device for periodontitis using the area under the receiver operating characteristic curve, sensitivity, specificity, and predictive values.

Materials and methods

Full-mouth periodontal examination and radiographic analysis were used for evaluating periodontal condition based on the 2018 classification of periodontal disease. A dichotomous diagnosis of clinical periodontal condition was performed using the POC device. The relationships among periodontal condition and the concentration of MMP-8, tooth loss (TL), gingival index (GI), plaque index (PI), and alveolar bone loss (ABL) were assessed by the Spearman rank correlations (rs).

Results

In all, 108 cases of non-periodontitis (NP) and 191 cases of periodontitis (P), including 38 cases of periodontitis stage I, 42 cases of periodontitis stage II, 99 cases of periodontitis stage III, and 11 cases of periodontitis stage IV, were enrolled in this study. Diagnostic accuracy in assessing periodontal condition with the POC device improved when it was used with participants aged ≥ 40 years. There were weak positive correlations between periodontal condition and MMP-8 and between periodontal condition and GI (rs2 = 0.1124 and rs2 = 0.0906, respectively), whereas a strong positive correlation between periodontal condition and alveolar bone loss (rs2 = 0.6877) was observed.

Conclusion

The POC device investigated in this study is a potential tool to distinguish between NP and P in individuals ≥ 40 years of age.

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Data availability

The data that support the findings of this study are available on request from the corresponding authors.

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Acknowledgements

The authors would like to thank Min Jung Son (M.J.S.) and Ka Won Kim (K.W.K.) for their help with the implementation of the POC test of each participant and with data collection.

Funding

This work was supported by Biotechnology Development Project—Advanced New Biomaterials (20000580, “Development of a Point of Care Testing System for High Sensitivity Detection of Biomarkers in Saliva”), funded by the Ministry of Trade, Industry, and Energy (MOTIE, Republic of Korea).

Author information

Authors and Affiliations

  1. Department of Periodontology, School of Dentistry and Dental Research Institute, Seoul National University, 101, Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea

    Young-Chang Ko, Jungwon Lee, Dongseob Lee, Yang-Jo Seol, Yong-Moo Lee & Ki-Tae Koo

  2. One-Stop Specialty Center, Seoul National University Dental Hospital, 101, Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea

    Jungwon Lee

  3. National Dental Care Center for Persons with Special Needs, Seoul National University Dental Hospital, 101, Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea

    Dongseob Lee

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  1. Young-Chang Ko
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Contributions

All authors have made substantial contributions to the conception and design of the study. JL and K-TK have been involved in the design of the work. JL has been involved in the acquisition and analysis of data. Y-CK and DL have been involved in the interpretation of data for the work. Y-CK and JL have been involved in drafting the work. DL, Y-JS, Y-ML, and K-TK have revised the manuscript critically for important intellectual content. All authors have been involved in the final approval of the version to be published. All authors have agreed to be accountable for all aspects of the work in ensuring that issues related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Corresponding authors

Correspondence to Jungwon Lee or Ki-Tae Koo.

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Ethics approval and consent to participate

This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the institutional review board of the Seoul National University Dental Hospital (CDE22001). Written informed consent was obtained from all individual participants included in the study.

Conflict of interest

The authors declare no competing interests.

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Ko, YC., Lee, J., Lee, D. et al. Diagnostic performance of a point-of-care test device for periodontitis using human saliva: a single-center, single-blinded, confirmatory study. Clin Oral Invest 28, 27 (2024). https://doi.org/10.1007/s00784-023-05443-y

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