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

March 25, 2025 updated by: Ceyhan CERAN SERDAR, Ankara Medipol University
Salivary and serum levels of TMAO and TNF-α can distinguish between individuals with periodontitis and periodontally healthy individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Fatih
      • İstanbul, Fatih, Turkey, 34083
        • Istanbul Medipol University, School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Systemically healthy individuals who applied to the Department of Periodontology at Istanbul Medipol University, Faculty of Dentistry between January 2024 and August 2024.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Individuals
Systemically healthy individuals without periodontitis
Diagnostic test: Salivary and Serum TMAO Mesurement
Salivary and serum TMAO levels were measured by liquid chromatography-mass spectrometry (LC-MS/MS)
Diagnostic test: Salivary and Serum TNF-α Mesurement
Salivary and serum TNF-α levels were measured by ELISA
Patients with Periodontitis
Systemically healthy individuals with periodontitis
Diagnostic test: Salivary and Serum TMAO Mesurement
Salivary and serum TMAO levels were measured by liquid chromatography-mass spectrometry (LC-MS/MS)
Diagnostic test: Salivary and Serum TNF-α Mesurement
Salivary and serum TNF-α levels were measured by ELISA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age
Time Frame: Baseline
Baseline
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Medipol University

Collaborators

Istanbul Medipol University Hospital
Ankara University
Acibadem University
Lokman Hekim Üniversitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2024

Primary Completion (Actual)

August 14, 2024

Study Completion (Actual)

September 23, 2024

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

April 2, 2025

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inflammation

Clinical Trials on Salivary and Serum TMAO Mesurement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe