Clinical trial NCT05448976: Potential Effect for the Smoking on Periodontitis From the Perspective of Arginine Metabolites
Official title: Potential Effect for the Smoking on Periodontitis From the Perspective of Arginine Metabolites Symmetric Dimethylarginine (SDMA) and Asymmetric Dimethylarginine (ADMA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Smoking
Inflammatory Response
Keywords: Periodontitis, Arginine metabolites, Smoking
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Saliva and serum of periodontitis and smoking patients collected for analyzing arginine metabolites.
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pocket probing depth
timeFrame: 6 months
measure: Clinical attachment level
timeFrame: 9 months
measure: Bleeding on probing
timeFrame: 9 months
Secondary outcomes:
measure: Saliva and serum samples processing
timeFrame: 2 months
measure: serum and saliva analyses for arginine metabolites
timeFrame: 2 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University, School of Dentistry
state: Fatih
Study officials:
affiliation: Istanbul Medipol University.Istanbul Medipol University, School of Dentistry Istanbul, Fatih, Turkey, 34083
name: Nur Balci, Assoc Prof
role: STUDY_CHAIR
References:
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.
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.
citation: 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.