Clinical trial NCT06580431: Trimethylamine N-oxide (TMAO) Levels in Periodontal Disease
Official title: Trimethylamine N-oxide (TMAO) Levels in Periodontal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Smoking
Inflammatory Response
Keywords: periodontal disease
smoking
TMAO
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 100
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 TMAO levels
Primary purpose: PREVENTION

Brief summary: Salivary and serum levels of TMAO and TNF-A can distinguish between individuals with periodontitis and periodontally healthy persons, including smoking and nonsmoking patients.

Detailed description: Tobacco use is a prevalent global habit with notable impacts on general health and periodontal disease. Trimethylamine N-oxide (TMAO) is a compound involved in the pathogenesis of various systemic inflammatory diseases, including cardiovascular conditions. The aim of this study was to determine differences in saliva and serum levels of TMAO between periodontitis and periodontally healthy patients according to smoking status.

The study includes four groups: systemically and periodontally healthy non-smokers (NS- Control; n = 25), systemically healthy non-smokers with Stage-III Grade-B periodontitis (NS- Periodontitis; n = 25), systemically and periodontally healthy smokers (S-Control; n = 25), and systemically healthy smokers with Stage-III Grade-C periodontitis (S-Periodontitis; n = 25). Periodontal parameters were recorded. TMAO levels were determined in saliva and serum samples using liquid chromatography-mass spectrometry (LC-MS/MS). TNF-α levels were measured by ELISA method.

Eligibility criteria: Inclusion Criteria:

* • systemically healthy

  * clinical diagnosis of periodontitis
  * clinical diagnosis of periodontal health
  * For smoking group : denied as smoking at least 10 cigarettes per day and the duration should more than 10 years.

Exclusion Criteria:

* decline to participate and being under 18 \&amp; over 65 years of age; (2) having any systemic inflammatory diseases such as diabetes, rheumatoid arthritis, or systemic conditions, including immunodeficiency syndrome, cardiovascular disorders, or hepatic disorders; (3) the use of antibiotics and/or anti-inflammatory nonsteroidal anti-inflammatory drugs within 3 months preceding the study; (4) having nonsurgical periodontal treatment (previous 6 months); (5)having surgical periodontal treatment (previous 12 months); (6)having \<20 natural teeth excluding the third molars.

Primary outcomes:
measure: Pocket probing depth
timeFrame: 3 months
measure: Clinical attachment level
timeFrame: 4 months
measure: Bleeding on probing
timeFrame: 4 months
Secondary outcomes:
measure: serum and saliva analyses for TMAO levels
timeFrame: 1 month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University, School of Dentistry
state: Fatih
Study officials:
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.