Serum and Saliva Sirtuin 6, Lipoxin A4, Caspase8 Levels in Correlation With Periodontal Status in Severe Periodontitis

Periodontitis Clinical Trial

Official title:

Serum and Saliva Sirtuin 6, Lipoxin A4, Caspase8 Levels in Correlation With Periodontal Status in Severe Periodontitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05417061
• Other study ID #: 138
• Status: Completed
• Phase: N/A
• Start date: October 14, 2021
• Est. completion date: May 30, 2022

Study information

• Verified date: June 2022
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 30, 2022
• Est. primary completion date: April 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• systemically healthy

• clinical diagnosis of periodontitis

• clinical diagnosis of periodontal health

Exclusion Criteria:

• history of regular use of systemic antibiotics anti-inflammatory, or antioxidant drugs (previous 3 months)

• nonsurgical periodontal treatment (previous 6 months)

• surgical periodontal treatment (previous 12 months)

• presence of<10 teeth

• current medications affecting gingival health (calcium channel blockers, phenytoin, cyclosporine, and hormone replacement therapy)

• diabetes

• diagnosis of rheumatoid arthritis

• pregnancy

• lactating

• smoking

• excessive alcohol consumption.

Related Conditions & MeSH terms

• Diagnose Disease
• Periodontitis

Intervention

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.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University, School of Dentistry	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Primary	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)	6 months
Primary	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.	6 months
Secondary	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.	2 months