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

NCT ID: NCT05448976

Last Updated: 2023-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-12

Study Completion Date

2022-05-16

Brief Summary

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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.

Detailed Description

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The study consisted of four groups: healthy individuals (control (C); n=20), smokers with healthy periodontium (S-C; n=20), nonsmokers with Stage III Grade B generalized periodontitis (P; n=20) and smokers with Stage III Grade C generalized periodontitis (S-P; n=18). Clinical periodontal parameters were measured. The determination of methylated arginine metabolites was carried out by LC-MS/MS.

Conditions

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Periodontitis Smoking Inflammatory Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Saliva and serum of periodontitis and smoking patients collected for analyzing arginine metabolites.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Saliva and serum collection of patients and samples molecules analysis

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.

Group Type ACTIVE_COMPARATOR

Saliva and serum sampling

Intervention Type 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.

Salivary and serum arginine metabolites ADMA and SDMA observation

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.

Group Type EXPERIMENTAL

Saliva and serum sampling

Intervention Type 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.

Interventions

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Saliva 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 (MFD) from each participant. Saliva and serum were then stored at -80 °C until analysis.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

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
* excessive alcohol consumption.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul Medipol University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nur Balci, DDs, PhD

ASSOC. PROF DR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nur Balci, Assoc Prof

Role: STUDY_CHAIR

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

Locations

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Istanbul Medipol University, School of Dentistry

Istanbul, Fatih, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 20837180 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29926952 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33977387 (View on PubMed)

Other Identifiers

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781

Identifier Type: -

Identifier Source: org_study_id

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