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Evaluation of Trimethylamine N-oxide (TMAO) Levels in Periodontal Disease

Evaluation of Trimethylamine N-oxide (TMAO) Levels in Periodontal Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06906510
Acronym
TMAO
Enrollment
48
Registered
2025-04-02
Start date
2024-01-08
Completion date
2024-09-23
Last updated
2025-04-02

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

Conditions

Inflammation, Periodontitis, TNF-alfa, Trimethylamine N-oxide (TMAO)

Keywords

periodontal disease, TMAO, TNF-α, periodontitis

Brief summary

Salivary and serum levels of TMAO and TNF-α can distinguish between individuals with periodontitis and periodontally healthy individuals.

Detailed description

Trimethylamine N-oxide (TMAO), a gut flora-derived metabolite from dietary choline, has emerged as an indicator of atherosclerosis. Circulatory TMAO has been implicated in cardiovascular risks by altering enterohepatic cholesterol and bile acid metabolism, increasing macrophage scavenger receptor expression, and activating nuclear factor kappa B (NF-κB) via pro-inflammatory genes such as interleukin-1 (IL-1). The pro-inflammatory cytokine tumor necrosis factor-alpha (TNF-α), which plays a crucial role in immune responses and inflammation, has been demonstrated as a crucial participant also during the development of periodontal diseases. The aim of this study is to evaluate difference in salivary and serum levels of TMAO and TNF-α between individuals with periodontitis and periodontally healthy individuals. The study includes two groups: systemically and periodontally healthy control subjects (n= 24), and patients with periodontitis (n=24). Periodontal parameters were recorded. TMAO levels in saliva and serum were determined by liquid chromatography-mass spectrometry (LC-MS/MS), and TNF-α levels were determined by ELISA.

Interventions

DIAGNOSTIC_TESTSalivary and Serum TMAO Mesurement

Salivary and serum TMAO levels were measured by liquid chromatography-mass spectrometry (LC-MS/MS)

DIAGNOSTIC_TESTSalivary and Serum TNF-α Mesurement

Salivary and serum TNF-α levels were measured by ELISA

Sponsors

Istanbul Medipol University Hospital
CollaboratorOTHER
Ankara University
CollaboratorOTHER
Acibadem University
CollaboratorOTHER
Lokman Hekim University
CollaboratorOTHER_GOV
Ankara Medipol University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

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

Inclusion criteria

* being over 18 and under 65 years of age; * having at least 20 natural teeth excluding the third molars; and * being systemically healthy.

Exclusion criteria

* being smoker; * chronic use of any systemic medication * use of antibiotics and/or anti-inflammatory steroids, nonsteroidal anti-inflammatory drugs, immunosuppressants, beta-blockers, calcium channel blockers, anticoagulants, or hormonal contraceptives within 3 months preceding the study; * pregnancy or lactation; and * use of orthodontic appliances

Design outcomes

Primary

MeasureTime frameDescription
Plaque index (PI)BaselineClinical parameters such as Probing depth (PD), Plaque index (PI), Bleeding on probing (BOP), and Clinical attachment loss (CAL) were recorded.
Clinical attachment loss (CAL)BaselineClinical parameters such as Probing depth (PD), Plaque index (PI), Bleeding on probing (BOP), and Clinical attachment loss (CAL) were recorded.
AgeBaseline
Probing depth (PD)BaselineClinical parameters such as Probing depth (PD), Plaque index (PI), Bleeding on probing (BOP), and Clinical attachment loss (CAL) were recorded.
Bleeding on probing (BOP)BaselineClinical parameters such as Probing depth (PD), Plaque index (PI), Bleeding on probing (BOP), and Clinical attachment loss (CAL) were recorded.

Secondary

MeasureTime frameDescription
Salivary and serum TNF-α levelsBaselineSalivary and serum TMAO and TNF-α levels are measured. Participants were instructed to rinse their mouths using filtered water and seated calmly while they spit into a disposable tube for five minutes, and saliva was collected from all patients. Saliva samples were prepared for storage by centrifugation at 3000 ×g for 10 minutes. Standard venipunctures were used to collect blood; the samples were stored at room temperature for 30 minutes. Serum was prepared from blood samples by centrifugation at 4000 ×g for 10 minutes. All serum and saliva samples have been transferred into Eppendorf tubes and preserved at -80oC until the analysis date. Salivary and serum TMAO levels were analyzed by LC-MS/MS. Salivary and serum TNF-α levels were measured using a commercial ELISA kit.
Salivary and serum TMAOBaselineSalivary and serum TMAO and TNF-α levels are measured. Participants were instructed to rinse their mouths using filtered water and seated calmly while they spit into a disposable tube for five minutes, and saliva was collected from all patients. Saliva samples were prepared for storage by centrifugation at 3000 ×g for 10 minutes. Standard venipunctures were used to collect blood; the samples were stored at room temperature for 30 minutes. Serum was prepared from blood samples by centrifugation at 4000 ×g for 10 minutes. All serum and saliva samples have been transferred into Eppendorf tubes and preserved at -80oC until the analysis date. Salivary and serum TMAO levels were analyzed by LC-MS/MS. Salivary and serum TNF-α levels were measured using a commercial ELISA kit.

Countries

Turkey (Türkiye)

Outcome results

None listed

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