NCT05417061

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 14, 2022

Completed
Last Updated

October 23, 2023

Status Verified

June 1, 2022

Enrollment Period

6 months

First QC Date

June 9, 2022

Last Update Submit

October 19, 2023

Conditions

Keywords

inflammation resolutionperiodontitiscell apoptosis

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 COMPARATOR
Other: Saliva and serum sampling

Salivary and serum SIRT6, LPXA4 and CASP8 observation

EXPERIMENTAL

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

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.

Saliva and serum collection of patients and samples molecules analysisSalivary and serum SIRT6, LPXA4 and CASP8 observation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

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.

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Saliva and serum of periodontitis patients collected for analyzing SIRT6, LPXA4, CASP8
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

Locations