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Completed

NCT Number: NCT06906510

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

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

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Key information

Conditions

Periodontitis Inflammation Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Stomatognathic Diseases TNF-alfa Trimethylamine N-oxide (TMAO)

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

İstanbul Medipol University, School of Dentistry

Istanbul, Fatih, 34083, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Salivary and Serum TMAO Mesurement

Diagnostic Test

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

Salivary and Serum TNF-α Mesurement

Diagnostic Test

Salivary and serum TNF-α levels were measured by ELISA

Primary outcomes

  1. Probing depth (PD)

    Time frame: Baseline

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

  2. Plaque index (PI)

    Time frame: Baseline

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

  3. Bleeding on probing (BOP)

    Time frame: Baseline

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

  4. Clinical attachment loss (CAL)

    Time frame: Baseline

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

  5. Age

    Time frame: Baseline

Secondary outcomes

  1. Salivary and serum TMAO

    Time frame: Baseline

    Salivary 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.

  2. Salivary and serum TNF-α levels

    Time frame: Baseline

    Salivary 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.

Sponsors and collaborators

Lead sponsor

Ankara Medipol University

Other

Collaborators

  • Acibadem University
  • Ankara University
  • Istanbul Medipol University Hospital
  • Lokman Hekim University

Registry information

Acronym: TMAO

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 2, 2025
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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