An interventional study of Saliva and serum sampling in Periodontitis and Diagnose Disease, sponsored by Istanbul Medipol University Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by Istanbul Medipol University Hospital · Not applicable, Interventional, and Prevention
It has been stated that Sirtuin-6 (SIRT6) play a important role in regulation of inflammation, energy metabolism, homeostasis and apoptosis, and SIRT6 may be assosiciated with many diseases. The aim of this study was to evaluate saliva and serum SIRT6, Lipoxin A4 (LXA4) and Caspase-8 (CASP8) levels in correlation with periodontal clinical status in patients with periodontitis and healthy subjects
20 patients with Stage III Grade B periodontitis (P) and 20 periodontally healthy individuals (control;C) were included in this study. Clinical periodontal parameters were measured. Saliva and serum levels of SIRT6, LXA4 and CASP8 were analyzed by enzyme-linked immunosorbent assay.
1,664 studies on the registry are indexed under Periodontitis; 328 are open to participants now.
This study's enrollment of 40 is below the median of 45 across 1,206 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →Istanbul Medipol University Hospital is the lead sponsor of 365 studies on the registry; 59 are open to participants now.
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Exclusion Criteria:
Other: Saliva and serum sampling
Saliva and serum samples obtained for each patient were used for cytokine analysis. Prepared samples were analyzed for Lipoxin A4 (LXA4), Caspase 8 (CASP8) and Sirtuin-6 (SIRT6) using commercial ELISA kits (Elabscience, Houston, Texas, USA and Bioaasay Technology Laboratory (BT-Lab), Shanghai, China, respectively) according to the manufacturer's instructions. The detection limits of ELISA kits were 0.78 - 50ng/ml for LXA4, 0.16 - 10ng/ml for CASP8 and 0.1- 40 ng/ml for SIRT6.
Other: Saliva and serum sampling
Saliva were collected to analyze the selected markers as unstimulated samples during the early hours of the day. The saliva was centrifuged and then transferred into Eppendorf tubes. Venous puncture was performed after saliva collection and 10 mL of blood samples were collected by qualified staff (MFD) from each participant. Saliva and serum were then stored at -80 °C until analysis.
Pocket probing depth
Measurement of the depth of a sulcus or periodontal pocket determined by measuring distance from a gingival margin to the base of the sulcus or pocket with a calibrated periodontal probe.
Time frame: 6 months
Clinical attachment level
Clinical attachment level (or loss, CAL) is a more accurate indicator of the periodontal support around a tooth than probing depth alone. CAL is measured from a fixed point on the tooth that does not change, the CEJ. To calculate CAL, two measurements are needed: distance from the gingival margin to the CEJ and probing depth. In recession: probing depth (+) gingival margin to the CEJ (add). In tissue overgrowth: probing depth (-) gingival margin to the CEJ (subtract)
Time frame: 6 months
Bleeding on probing
referring to bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus, or interface between the gingiva and a tooth.
Time frame: 6 months
Saliva and serum samples processing and analyses
Saliva and serum samples obtained for each patient were used for cytokine analysis. Prepared samples were analyzed for Lipoxin A4 (LXA4), Caspase 8 (CASP8) and Sirtuin-6 (SIRT6) using commercial ELISA kits (Elabscience, Houston, Texas, USA and Bioaasay Technology Laboratory (BT-Lab), Shanghai, China, respectively) according to the manufacturer's instructions.
Time frame: 2 months
Plan to share: No
Ran from Oct 2021 to primary completion in Apr 2022, 6 months.
Of 605 non-industry interventional studies with no phase under Periodontitis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 28. This study's 6 months is below that.
Counting every sponsor, half of 624 studies reached it within 15 months; a quarter within 7 and three quarters within 28.
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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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