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Trimethylamine N-oxide (TMAO) Levels in Periodontal Disease

Trimethylamine N-oxide (TMAO) Levels in Periodontal Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06580431
Enrollment
100
Registered
2024-08-30
Start date
2023-12-21
Completion date
2024-06-25
Last updated
2024-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Response, Periodontitis, Smoking

Keywords

periodontal disease, smoking, TMAO

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.

Interventions

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.

Sponsors

Istanbul Medipol University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Saliva and serum of periodontitis and smoking patients collected for analyzing TMAO levels

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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 & 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.

Design outcomes

Primary

MeasureTime frameDescription
Pocket probing depth3 monthsMeasurement 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 level4 monthsClinical 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 probing4 monthsBleeding 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

MeasureTime frameDescription
serum and saliva analyses for TMAO levels1 monthTMAO levels were determined in saliva and serum samples using liquid chromatography-mass spectrometry (LC-MS/MS). TNF-α levels were measured by ELISA method.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026