Serum and Saliva Sirtuin 6, Lipoxin A4, Caspase8 Levels in Correlation With Periodontal Status in Severe Periodontitis
1 other identifier
interventional
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2022
CompletedFirst Submitted
Initial submission to the registry
June 9, 2022
CompletedFirst Posted
Study publicly available on registry
June 14, 2022
CompletedOctober 23, 2023
June 1, 2022
6 months
June 9, 2022
October 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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 Outcomes (1)
Saliva and serum samples processing and analyses
2 months
Study Arms (2)
Saliva and serum collection of patients and samples molecules analysis
ACTIVE COMPARATORSalivary and serum SIRT6, LPXA4 and CASP8 observation
EXPERIMENTALSaliva 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- systemically healthy
- clinical diagnosis of periodontitis
- clinical diagnosis of periodontal health
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul Medipol University, School of Dentistry
Istanbul, Fatih, 34083, Turkey (Türkiye)
Related Publications (1)
Cekici A, Sahinkaya S, Donmez MF, Turkmen E, Balci N, Toygar H. Sirtuin6 and Lipoxin A4 levels are decreased in severe periodontitis. Clin Oral Investig. 2023 Dec;27(12):7407-7415. doi: 10.1007/s00784-023-05330-6. Epub 2023 Oct 18.
PMID: 37851128DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- ASSOC. PROF DR
Study Record Dates
First Submitted
June 9, 2022
First Posted
June 14, 2022
Study Start
October 14, 2021
Primary Completion
April 21, 2022
Study Completion
May 30, 2022
Last Updated
October 23, 2023
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share