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

NCT06906510 | Completed

• 1 other identifier: 1004
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

periodontal disease; TMAO; TNF-α; periodontitis

Outcome Measures

Primary Outcomes (5)

• Probing depth (PD)

  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)

  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)

  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)

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

  Baseline

• Age

  Baseline

Secondary Outcomes (2)

• Salivary and serum TMAO

  Baseline

• Salivary and serum TNF-α levels

  Baseline

Study Arms (2)

Healthy Individuals

Systemically healthy individuals without periodontitis

Diagnostic Test: Salivary and Serum TMAO Mesurement; Diagnostic Test: Salivary and Serum TNF-α Mesurement

Patients with Periodontitis

Systemically healthy individuals with periodontitis

Diagnostic Test: Salivary and Serum TMAO Mesurement; Diagnostic Test: Salivary and Serum TNF-α Mesurement

Interventions

Salivary and Serum TMAO Mesurement DIAGNOSTIC_TEST

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

Healthy Individuals; Patients with Periodontitis

Salivary and Serum TNF-α Mesurement DIAGNOSTIC_TEST

Salivary and serum TNF-α levels were measured by ELISA

Healthy Individuals; Patients with Periodontitis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Medipol University: lead
• Istanbul Medipol University Hospital: collaborator
• Ankara University: collaborator
• Acibadem University: collaborator
• Lokman Hekim University: collaborator

Study Sites (1)

İstanbul Medipol University, School of Dentistry

Istanbul, Fatih, 34083, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 21731245 BACKGROUND

• 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.

  PMID: 17116158 BACKGROUND

• 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.

  PMID: 25716960 BACKGROUND

• 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.

  PMID: 29926952 BACKGROUND

• 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.

  PMID: 38415052 BACKGROUND

• 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.

  PMID: 34472093 BACKGROUND

• 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.

  PMID: 25870193 BACKGROUND

• 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.

  PMID: 32291445 BACKGROUND

MeSH Terms

Conditions

Periodontitis; Inflammation; Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof.

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: April 2, 2025
• Study Start: January 8, 2024
• Primary Completion: August 14, 2024
• Study Completion: September 23, 2024
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)