Potential Effect for the Smoking on Periodontitis From the Perspective of Arginine Metabolites

NCT05448976 | Completed

• 1 other identifier: 781
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Arginine metabolites are amino acids that are associated with vascular tone regulation and the level of inflammation, with critical roles in the synthesis of NO. Our aim was to determine the ADMA, SDMA, L-NMMA, L-arginine, L-homoarginine and IL-6 levels in saliva and serum samples from periodontitis patients and periodontally healthy individuals and to assess the levels of these compounds according to smoking status and compare these levels to those of healthy individuals.

Conditions

Periodontitis; Smoking; Inflammatory Response

Keywords

Periodontitis, Arginine metabolites, Smoking

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)

  9 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

  9 months

Secondary Outcomes (2)

• Saliva and serum samples processing

  2 months

• serum and saliva analyses for arginine metabolites

  2 months

Study Arms (2)

Saliva and serum collection of patients and samples molecules analysis

ACTIVE COMPARATOR

aliva 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 (MY,EY) from each participant. Saliva and serum were then stored at -80 °C until analysis.

Other: Saliva and serum sampling

Salivary and serum arginine metabolites ADMA and SDMA observation

EXPERIMENTAL

IL-6 levels in collected samples were determined by ELISA kits and analyzed according to manufacturers' instructions, with colorimetric assessment performed using a microplate reader at 450 nm with the assay detection range between 7.8 and 500 pg/mL. Concentrations were determined based on the respective assay standard curve. All samples were analyzed in duplicate, and the average was used in subsequent calculations. Determination of methylated arginine metabolites: The ADMA, SDMA, homoArg, arginine and L-NMMA levels in saliva and serum were assessed by a liquid chromatography-mass spectrometry (LC MS/MS)\* method, which was a modification of the method of Di Gangi et al.

Other: Saliva and serum sampling

Interventions

Saliva and serum sampling OTHER

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 analysis; Salivary and serum arginine metabolites ADMA and SDMA observation

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
• For smoking group the so kerr were denied as smoking at least 10 cigarettes per day and the duration should more than 10 years.

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
• excessive alcohol consumption.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University, School of Dentistry

Istanbul, Fatih, 34083, Turkey (Türkiye)

Location

Related Publications (3)

• Di Gangi IM, Chiandetti L, Gucciardi A, Moret V, Naturale M, Giordano G. Simultaneous quantitative determination of N(G),N(G)-dimethyl-L-arginine or asymmetric dimethylarginine and related pathway's metabolites in biological fluids by ultrahigh-performance liquid chromatography/electrospray ionization-tandem mass spectrometry. Anal Chim Acta. 2010 Sep 16;677(2):140-8. doi: 10.1016/j.aca.2010.08.011. Epub 2010 Aug 17.

  PMID: 20837180 BACKGROUND

• Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.

  PMID: 29926952 BACKGROUND

• Balci N, Kurgan S, Cekici A, Cakir T, Serdar MA. Free amino acid composition of saliva in patients with healthy periodontium and periodontitis. Clin Oral Investig. 2021 Jun;25(6):4175-4183. doi: 10.1007/s00784-021-03977-7. Epub 2021 May 11.

  PMID: 33977387 BACKGROUND

MeSH Terms

Conditions

Periodontitis; Smoking

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Behavior

Study Officials

• Nur Balci, Assoc Prof

  Istanbul Medipol University.Istanbul Medipol University, School of Dentistry Istanbul, Fatih, Turkey, 34083

  STUDY CHAIR

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

Model Details: Saliva and serum of periodontitis and smoking patients collected for analyzing arginine metabolites.

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 8, 2022
• Study Start: August 12, 2021
• Primary Completion: April 6, 2022
• Study Completion: May 16, 2022
• Last Updated: October 24, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)