Back to resultsSerum and Saliva Sirtuin 6, Lipoxin A4, Caspase8 Levels in Correlation With Periodontal Status in Severe Periodontitis
Primary Purpose
Periodontitis, Diagnose Disease
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Saliva and serum sampling
Sponsored by
About this trial
This is an interventional prevention trial for Periodontitis focused on measuring inflammation resolution, periodontitis, cell apoptosis
Eligibility Criteria
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.
Sites / Locations
- Istanbul Medipol University, School of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Saliva and serum collection of patients and samples molecules analysis
Salivary and serum SIRT6, LPXA4 and CASP8 observation
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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)
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05417061
First Posted
June 9, 2022
Last Updated
October 19, 2023
Sponsor
Istanbul Medipol University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05417061
Brief Title
Serum and Saliva Sirtuin 6, Lipoxin A4, Caspase8 Levels in Correlation With Periodontal Status in Severe Periodontitis
Official Title
Serum and Saliva Sirtuin 6, Lipoxin A4, Caspase8 Levels in Correlation With Periodontal Status in Severe Periodontitis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 14, 2021 (Actual)
Primary Completion Date
April 21, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Diagnose Disease
Keywords
inflammation resolution, periodontitis, cell apoptosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Saliva and serum of periodontitis patients collected for analyzing SIRT6, LPXA4, CASP8
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saliva and serum collection of patients and samples molecules analysis
Arm Type
Active Comparator
Arm Title
Salivary and serum SIRT6, LPXA4 and CASP8 observation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Saliva and serum sampling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pocket probing depth
Description
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
Title
Clinical attachment level
Description
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
Title
Bleeding on probing
Description
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
Secondary Outcome Measure Information:
Title
Saliva and serum samples processing and analyses
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Istanbul Medipol University, School of Dentistry
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34083
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Serum and Saliva Sirtuin 6, Lipoxin A4, Caspase8 Levels in Correlation With Periodontal Status in Severe Periodontitis
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