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

Smoking Clinical Trial

Official title:

Potential Effect for the Smoking on Periodontitis From the Perspective of Arginine Metabolites Symmetric Dimethylarginine (SDMA) and Asymmetric Dimethylarginine (ADMA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05448976
• Other study ID #: 781
• Status: Completed
• Phase: N/A
• Start date: August 12, 2021
• Est. completion date: May 16, 2022

Study information

• Verified date: July 2022
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 16, 2022
• Est. primary completion date: April 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammatory Response
• Periodontitis
• Smoking

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University, School of Dentistry	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. Erratum In: J Periodontol. 2018 Dec;89(12):1475. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Saliva and serum samples processing	Phenomenex (Torrance, CA, USA) 75 x 4.6 mm x 4 µm polar-RP column, Dionex HPLC and Access MAX LC-MSMS (Thermo Scientific, USA) device were used; in the gradient phase mobile phase A (40 mM ammoniumformate, 3% formic acid) and mobile phase B (acetonitrile) were utilized. A flow chart with increasing in steps of 2-8 minutes for 10% B phase, 30% B phase for 8-11 minutes, and finally 10% B phase for 11-20 minutes was applied at a flow rate of 0.3 ml/min. MRM and CE values were as follows: Arginine 231.3-70.1 CE: 15 V; Homoarginine 245.2-84.2 CE: 24 V; L-NMMA 245.3-70.2 CE:15V; ADMA 259.3-214.0; CE:25V; SDMA 259.3-228.0 CE:15V; ADMA-D7 266.610-221.000 CE:15V; capillary temperature 210 °C; Vaporizer temperature 350 °C; Sheath gas pressure: 30 Arb.; Aux Gas pressure:10 Arb.; Ion Sweep Gas Pressure: 0; Spray Voltage: 3000 V; Polarity: (+).	2 months
Secondary	serum and saliva analyses for 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.	2 months