Saliva Irisin Level is Higher and Related With Interleukin 6 in Generalized Periodontitis

NCT05474820 | Completed

• 1 other identifier: 361
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Irisin is novel adipomyokine known as a mediator of physical activity that produced mainly by skeletal muscle and adipose tissues. It is cleaved from the fibronectin type III domain-containing protein 5 (FDNC5), which is, in turn, induced by peroxisome proliferator-activated receptor-ɣ co-activator 1-α (PGC-1α). Several studies reported that irisin is related with pathogenesis of many diseases which are known to be associated with periodontal disease such as obesity, diabetes mellitus, rheumatoid arthritis, cardiovascular disease, nonalcoholic fatty liver disease and metabolic bone diseases. There are several studies those have reported that increased IL-6 levels are associated with progression and severity of periodontitis . Recently, it has been shown that irisin is expressed in human periodontal ligament cells (hPDL), dental pulp stem cells and osteoblasts. Also, a few studies revealed that irisin promotes growth, migration and matrix formation in hPDL cells and cementoblast differentiation. To the best our knowledge, there 's one study has been reported that the higher levels of irisin in saliva in patient with chronic periodontitis

Conditions

Inflammatory Response; Periodontitis

Keywords

periodontitis; irisin

Outcome Measures

Primary Outcomes (2)

• 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.

  3 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)

  3 months

Secondary Outcomes (1)

• Saliva and serum samples processing and analyses

  1 month

Study Arms (2)

Saliva and serum collection of patients and samples molecules analysis

OTHER

After periodontal examination, samples were collected from all patients via informing them about procedures. Then all samples were stored at -80 C unto analyses.

Other: Samples collection and ELISA analyses; Diagnostic Test: Evaluating periodontal paramètres

Periodontal examination

OTHER

All periodontal indices were measured in six sites in each tooth present in the arch by one calibrated periodontist

Other: Samples collection and ELISA analyses; Diagnostic Test: Evaluating periodontal paramètres

Interventions

Samples collection and ELISA analyses OTHER

The serum and unstimulated saliva samples were taken from all patients between 8:00 and 10:00 in the morning. Saliva samples were centrifuged at 10,000 rpm (10 min) whereas venous blood samples were centrifuged at 4000 rpm for 10 min. For the analysis of irisin and IL-6 specific ELISA Kits (Elabscience, Houston, Texas, USA) were used to determine the molecules in both serum and saliva samples in accordance with the manufacturer's instructions. All samples were run in duplicate, and values have been averaged.

Periodontal examination; Saliva and serum collection of patients and samples molecules analysis

Evaluating periodontal paramètres DIAGNOSTIC_TEST

The clinical periodontal parameters (plaque index (PI), probing pocket depth (PD), gingival recession (GR), clinical attachment loss (CAL), and bleeding on probing (BOP)) were recorded on periodontal charts in each patient

Periodontal examination; Saliva and serum collection of patients and samples molecules analysis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University, School of Dentistry

Istanbul, 34083, Turkey (Türkiye)

Location

Related Publications (1)

• Pullisaar H, Colaianni G, Lian AM, Vandevska-Radunovic V, Grano M, Reseland JE. Irisin promotes growth, migration and matrix formation in human periodontal ligament cells. Arch Oral Biol. 2020 Mar;111:104635. doi: 10.1016/j.archoralbio.2019.104635. Epub 2019 Dec 16.

  PMID: 31869727 BACKGROUND

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOC. PROF DR

Study Record Dates

• First Submitted: July 23, 2022
• First Posted: July 26, 2022
• Study Start: February 24, 2022
• Primary Completion: June 20, 2022
• Study Completion: July 19, 2022
• Last Updated: October 23, 2023

Record last verified: 2022-07

Locations

TU (1)