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

NCT ID: NCT06906510

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-08

Study Completion Date

2024-09-23

Brief Summary

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

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy Individuals

Systemically healthy individuals without periodontitis

Salivary and Serum TMAO Mesurement

Intervention Type DIAGNOSTIC_TEST

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

Salivary and Serum TNF-α Mesurement

Intervention Type DIAGNOSTIC_TEST

Salivary and serum TNF-α levels were measured by ELISA

Patients with Periodontitis

Systemically healthy individuals with periodontitis

Salivary and Serum TMAO Mesurement

Intervention Type DIAGNOSTIC_TEST

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

Salivary and Serum TNF-α Mesurement

Intervention Type DIAGNOSTIC_TEST

Salivary and serum TNF-α levels were measured by ELISA

Interventions

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Salivary and Serum TMAO Mesurement

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

Intervention Type DIAGNOSTIC_TEST

Salivary and Serum TNF-α Mesurement

Salivary and serum TNF-α levels were measured by ELISA

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul Medipol University Hospital

OTHER

Sponsor Role collaborator

Ankara University

OTHER

Sponsor Role collaborator

Acibadem University

OTHER

Sponsor Role collaborator

Lokman Hekim University

OTHER_GOV

Sponsor Role collaborator

Ankara Medipol University

OTHER

Sponsor Role lead

Responsible Party

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Ceyhan CERAN SERDAR

Assistant Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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İstanbul Medipol University, School of Dentistry

Istanbul, Fatih, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Khanna S, Mali AM. Evaluation of tumor necrosis factor-alpha (TNF-alpha) levels in plasma and their correlation with periodontal status in obese and non-obese subjects. J Indian Soc Periodontol. 2010 Oct;14(4):217-21. doi: 10.4103/0972-124X.76920.

Reference Type BACKGROUND
PMID: 21731245 (View on PubMed)

Engebretson S, Chertog R, Nichols A, Hey-Hadavi J, Celenti R, Grbic J. Plasma levels of tumour necrosis factor-alpha in patients with chronic periodontitis and type 2 diabetes. J Clin Periodontol. 2007 Jan;34(1):18-24. doi: 10.1111/j.1600-051X.2006.01017.x. Epub 2006 Nov 20.

Reference Type BACKGROUND
PMID: 17116158 (View on PubMed)

Buczko P, Zalewska A, Szarmach I. Saliva and oxidative stress in oral cavity and in some systemic disorders. J Physiol Pharmacol. 2015 Feb;66(1):3-9.

Reference Type BACKGROUND
PMID: 25716960 (View on PubMed)

Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.

Reference Type BACKGROUND
PMID: 29926952 (View on PubMed)

Hernandez-Ruiz P, Escalona Montano AR, Amezcua-Guerra LM, Gonzalez-Pacheco H, Niccolai E, Amedei A, Aguirre-Garcia MM. Potential Association of the Oral Microbiome with Trimethylamine N-Oxide Quantification in Mexican Patients with Myocardial Infarction. Mediators Inflamm. 2024 Feb 20;2024:3985731. doi: 10.1155/2024/3985731. eCollection 2024.

Reference Type BACKGROUND
PMID: 38415052 (View on PubMed)

Zhou J, Chen S, Ren J, Zou H, Liu Y, Chen Y, Qiu Y, Zhuang W, Tao J, Yang J. Association of enhanced circulating trimethylamine N-oxide with vascular endothelial dysfunction in periodontitis patients. J Periodontol. 2022 May;93(5):770-779. doi: 10.1002/JPER.21-0159. Epub 2021 Nov 3.

Reference Type BACKGROUND
PMID: 34472093 (View on PubMed)

Yang T, Santisteban MM, Rodriguez V, Li E, Ahmari N, Carvajal JM, Zadeh M, Gong M, Qi Y, Zubcevic J, Sahay B, Pepine CJ, Raizada MK, Mohamadzadeh M. Gut dysbiosis is linked to hypertension. Hypertension. 2015 Jun;65(6):1331-40. doi: 10.1161/HYPERTENSIONAHA.115.05315. Epub 2015 Apr 13.

Reference Type BACKGROUND
PMID: 25870193 (View on PubMed)

Wu K, Yuan Y, Yu H, Dai X, Wang S, Sun Z, Wang F, Fei H, Lin Q, Jiang H, Chen T. The gut microbial metabolite trimethylamine N-oxide aggravates GVHD by inducing M1 macrophage polarization in mice. Blood. 2020 Jul 23;136(4):501-515. doi: 10.1182/blood.2019003990.

Reference Type BACKGROUND
PMID: 32291445 (View on PubMed)

Other Identifiers

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1004

Identifier Type: -

Identifier Source: org_study_id

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