Skip to main content
OpenTrials
Completed

NCT Number: NCT05448976

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Periodontitis Behavior Inflammatory Response Mouth Diseases Periodontal Diseases Smoking Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University, School of Dentistry

Istanbul, Fatih, 34083, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Pocket probing depth

    Time frame: 6 months

    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

  2. Clinical attachment level

    Time frame: 9 months

    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. Bleeding on probing

    Time frame: 9 months

    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

Secondary outcomes

  1. Saliva and serum samples processing

    Time frame: 2 months

    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. serum and saliva analyses for arginine metabolites

    Time frame: 2 months

    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.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 8, 2022
Registry last updated
Oct 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.