Trimethylamine N-oxide (TMAO) Levels in Periodontal Disease

Not Applicable

Completed

• Conditions: Periodontitis; Smoking; Inflammatory Response

• Registration Number: NCT06580431
• Lead Sponsor: Istanbul Medipol University Hospital

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.

Study Timeline

• Study Start: 2023-12-21
• Primary Completion: 2024-05-23
• Study Completion: 2024-06-25
• Status Verified: 2024-08
• Study First Submitted: 2024-08-28
• Study First Submitted QC: 2024-08-28
• Last Update Submitted: 2024-08-28
• Study First Posted: 2024-08-30
• Last Update Posted: 2024-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pocket probing depth	3 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
Clinical attachment level	4 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)
Bleeding on probing	4 months	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

Secondary Outcome Measures

Name	Time	Method
serum and saliva analyses for TMAO levels	1 month	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.

Trial Locations

Locations (1)

Istanbul Medipol University, School of Dentistry; 🇹🇷 Istanbul, Fatih, Turkey