Trimethylamine N-oxide (TMAO) Levels in Periodontal Disease

Medipol Health Group

Status: Completed

Conditions: Periodontitis; Inflammatory Response; Smoking

Treatments: Other: Saliva and serum sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT06580431

1061

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Active Comparator

Active Comparator group

Description:

Saliva and serum collection of patients and samples molecules analysis 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 from each participant. Saliva and serum were then stored at -80 °C until analysis.

Treatment:

Other: Saliva and serum sampling

Salivary and serum TMAO observation

Experimental group

Description:

TNF-α levels in collected saliva and serum samples were measured by commercial ELISA kits (ELISA Cloud Immunoassay, Cloud Clone Corp; cat #SEA079Hu) and analyzed according to manufacturers\&#39; instructions. The standard curve of the assay was used to determine the analyte concentrations in each sample. All samples were analyzed in duplicate, and the mean values were used in subsequent calculations. TMAO levels in saliva and serum were determined by a liquid chromatography-mass spectrometry (LC MS/MS) method (LC-MS/MS, ESI Source, Thermo Scientific Accessmax), which was a modification of the method by Li et al and similar as our previous study.(Yufei Li, Kang, Lee, Chung, \&amp; Cho, 2021) To identify and quantify TMAO, samples were analyzed by an LC-MS/MS 1 system equipped with a Thermo Dionex Ultimate 3000 UHPLC system and an TSQ Quantum Access Max quadrupole mass spectrometer (USA).

Treatment:

Other: Saliva and serum sampling