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

Sponsor

Istanbul Medipol University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05417061

Collaborator

(none)

Enrollment

Location

Arms

7.5

Actual Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Periodontitis Diagnose Disease	Other: Saliva and serum sampling	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Saliva and serum of periodontitis patients collected for analyzing SIRT6, LPXA4, CASP8Saliva and serum of periodontitis patients collected for analyzing SIRT6, LPXA4, CASP8

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 14, 2021

Actual Primary Completion Date :

Apr 21, 2022

Actual Study Completion Date :

May 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Saliva and serum collection of patients and samples molecules analysis	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.
Experimental: Salivary and serum SIRT6, LPXA4 and CASP8 observation 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.

Arm

Intervention/Treatment

Active Comparator: Saliva and serum collection of patients and samples molecules analysis

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.

Experimental: Salivary and serum SIRT6, LPXA4 and CASP8 observation

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

Outcome Measures

Primary Outcome Measures

Pocket probing depth [6 months]
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.
Clinical attachment level [6 months]
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)
Bleeding on probing [6 months]
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.

Secondary Outcome Measures

Saliva and serum samples processing and analyses [2 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul Medipol University, School of Dentistry	Istanbul	Fatih	Turkey	34083

Sponsors and Collaborators

Istanbul Medipol University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Istanbul Medipol University Hospital

ClinicalTrials.gov Identifier:

NCT05417061

Other Study ID Numbers:

First Posted:

Jun 14, 2022

Last Update Posted:

Jun 23, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Istanbul Medipol University Hospital

inflammation resolution

periodontitis

cell apoptosis

Additional relevant MeSH terms:

Periodontitis

Study Results

No Results Posted as of Jun 23, 2022