Trimethylamine N-oxide (TMAO) Levels in Periodontal Disease

NCT06580431 | Completed

• 1 other identifier: 1061
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Salivary and serum levels of TMAO and TNF-A can distinguish between individuals with periodontitis and periodontally healthy persons, including smoking and nonsmoking patients.

Conditions

Periodontitis; Smoking; Inflammatory Response

Keywords

periodontal disease; smoking; TMAO

Outcome Measures

Primary Outcomes (3)

• Pocket probing depth

  Measurement of the depth of a sulcus or periodontal pocket determined by measuring distance from a gingival margin to the base of the sulcus or pocket with a calibrated periodontal probe

  3 months

• Clinical attachment level

  Clinical attachment level (or loss, CAL) is a more accurate indicator of the periodontal support around a tooth than probing depth alone. CAL is measured from a fixed point on the tooth that does not change, the CEJ. To calculate CAL, two measurements are needed: distance from the gingival margin to the CEJ and probing depth. In recession: probing depth (+) gingival margin to the CEJ (add). In tissue overgrowth: probing depth (-) gingival margin to the CEJ (subtract)

  4 months

• Bleeding on probing

  Bleeding on probing referring to bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus, or interface between the gingiva and a tooth

  4 months

Secondary Outcomes (1)

• serum and saliva analyses for TMAO levels

  1 month

Study Arms (2)

Active Comparator

ACTIVE COMPARATOR

Saliva and serum collection of patients and samples molecules analysis Saliva and serum sampling Saliva were collected to analyze the selected markers as unstimulated samples during the early hours of the day. The saliva was centrifuged and then transferred into Eppendorf tubes. Venous puncture was performed after saliva collection and 10 mL of blood samples were collected by qualified staff from each participant. Saliva and serum were then stored at -80 °C until analysis.

Other: Saliva and serum sampling

Salivary and serum TMAO observation

EXPERIMENTAL

TNF-α levels in collected saliva and serum samples were measured by commercial ELISA kits (ELISA Cloud Immunoassay, Cloud Clone Corp; cat #SEA079Hu) and analyzed according to manufacturers\' instructions. The standard curve of the assay was used to determine the analyte concentrations in each sample. All samples were analyzed in duplicate, and the mean values were used in subsequent calculations. TMAO levels in saliva and serum were determined by a liquid chromatography-mass spectrometry (LC MS/MS) method (LC-MS/MS, ESI Source, Thermo Scientific Accessmax), which was a modification of the method by Li et al and similar as our previous study.(Yufei Li, Kang, Lee, Chung, \& Cho, 2021) To identify and quantify TMAO, samples were analyzed by an LC-MS/MS 1 system equipped with a Thermo Dionex Ultimate 3000 UHPLC system and an TSQ Quantum Access Max quadrupole mass spectrometer (USA).

Other: Saliva and serum sampling

Interventions

Saliva and serum sampling OTHER

Saliva were collected to analyze the selected markers as unstimulated samples during the early hours of the day. The saliva was centrifuged and then transferred into Eppendorf tubes. Venous puncture was performed after saliva collection and 10 mL of blood samples were collected by qualified staff from each participant. Saliva and serum were then stored at -80 °C until analysis.

Active Comparator; Salivary and serum TMAO observation

Eligibility Criteria

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

You may qualify if:

• systemically healthy
• clinical diagnosis of periodontitis
• clinical diagnosis of periodontal health
• For smoking group : denied as smoking at least 10 cigarettes per day and the duration should more than 10 years.

You may not qualify if:

• decline to participate and being under 18 \&amp; over 65 years of age; (2) having any systemic inflammatory diseases such as diabetes, rheumatoid arthritis, or systemic conditions, including immunodeficiency syndrome, cardiovascular disorders, or hepatic disorders; (3) the use of antibiotics and/or anti-inflammatory nonsteroidal anti-inflammatory drugs within 3 months preceding the study; (4) having nonsurgical periodontal treatment (previous 6 months); (5)having surgical periodontal treatment (previous 12 months); (6)having \<20 natural teeth excluding the third molars.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University, School of Dentistry

Istanbul, Fatih, 34083, Turkey (Türkiye)

Location

Related Publications (2)

• Di Gangi IM, Chiandetti L, Gucciardi A, Moret V, Naturale M, Giordano G. Simultaneous quantitative determination of N(G),N(G)-dimethyl-L-arginine or asymmetric dimethylarginine and related pathway's metabolites in biological fluids by ultrahigh-performance liquid chromatography/electrospray ionization-tandem mass spectrometry. Anal Chim Acta. 2010 Sep 16;677(2):140-8. doi: 10.1016/j.aca.2010.08.011. Epub 2010 Aug 17.

  PMID: 20837180 RESULT

• Bal I, Balci N, Sorguc C, Toygar HU, Serdar CC, Kurgan S, Serdar MA. Trimethylamine N-Oxide (TMAO) and TNF-alpha Levels in Periodontal Disease Associated With Smoking. Oral Dis. 2025 Jul;31(7):2282-2292. doi: 10.1111/odi.15262. Epub 2025 Jan 30.

  PMID: 39887517 DERIVED

MeSH Terms

Conditions

Periodontitis; Smoking; Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDs, PhD

Model Details: Saliva and serum of periodontitis and smoking patients collected for analyzing TMAO levels

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: August 30, 2024
• Study Start: December 21, 2023
• Primary Completion: May 23, 2024
• Study Completion: June 25, 2024
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)