An observational study in Periodontitis and Diagnostic Self Evaluation, sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University. Completed at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-31.
Sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Observational
The application of point-of-care test with oral fluid-based biomarkers assisting in early-detection of gum disease is highly needed. Recently, a commercially available active Matrix metalloproteinase-8 (aMMP-8) point-of-care test (POCT) for detecting the risk of gum disease has been developed. Currently, there is a paucity of research to assess the performance of aMMP-8 POCT using different oral fluid sampling methods. This study will evaluate the accuracy of aMMP-8 POCT for discriminating periodontal health from disease in saliva and oral rinse.The information obtained from this study may help us understand better which sample is superior for the early detection of gum disease.
The detection of the risk for periodontitis, one of the major global burdens of disease, prior to noticeable signs and symptoms is of great importance especially in non-dental settings. Oral fluids, including gingival crevicular fluid (GCF), saliva and oral rinse, have received considerable critical attention in the field of periodontal diagnostics for their non-invasive features and rich sources of biomarkers associated with the biological process in periodontal tissues. Saliva and oral rinse are preferred for screening purposes in a chair-side test, while GCF provides more site-specific information and has higher technical requirements.
Matrix metalloproteinases (MMPs) are a family of key host proteinases that regulate cell-matrix composition and MMP-8 is the main type of collagenases of MMP family responsible for collagen degradation of the periodontal supporting tissues. A growing body of evidence have indicated that elevated MMP-8, especially active form of MMP-8 (aMMP-8), has been detected in oral fluids of periodontitis (Kc et al., 2020). Currently, a commercially available aMMP-8 point-of-care test (POCT) has been developed (U.S. Patent No. 10,488,415, 2019). A recent study has assessed the diagnostic utility of this aMMP-8 POCT using oral rinse samples and showed moderate accuracy for detecting periodontitis (Deng et al., 2021). So far, however, there is a paucity of research to assess the performance of aMMP-8 POCT using different oral fluid sampling methods.
The study aims: i)to compare the diagnostic accuracy of aMMP-8 POCT for the discrimination of periodontal health and disease(s) in oral rinse and saliva; ii) to compare the diagnostic accuracy of aMMP-8 POCT for the discrimination of periodontal health and disease(s) in oral rinse during the first sampling and re-sampling.
This study is a cross-sectional diagnostic study.The whole study procedures will comprise the collection of different oral fluid samples, the conduction of aMMP-8 POCT using these samples (index test), followed by a routine full-mouth periodontal examination (reference standard). The details of the sequential study events include: 1) collection of unstimulated whole saliva sample by spitting method; 2) the first-time sampling of oral rinse (pure oral rinse); 3) re-sampling of oral rinse; 4) conduction of aMMP-8 point-of-care test using saliva and oral rinse samples collected at different times; and 5) routing full-mouth periodontal examinations to establish clinical case diagnosis.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's enrollment of 95 is close to the median of 90 across 428 observational studies indexed under Periodontitis.
Browse Periodontitis studies →Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University is the lead sponsor of 160 studies on the registry; 70 are open to participants now.
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Consenting untreated patients seeking care at the Periodontology clinic and Implant Dentistry clinic of Shanghai Ninth People's Hospital.
Exclusion Criteria:
The area under the receiver operating characteristic curve (AUROC) measure
Comparing the area under the receiver operating characteristic curve (AUROC) of aMMP-8 in different samples to correctly identify periodontitis cases at the time of completion of clinical examination
Time frame: 1day
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University