Clinical trial NCT06906510: Evaluation of Trimethylamine N-oxide (TMAO) Levels in Periodontal Disease
Official title: Evaluation of Trimethylamine N-oxide (TMAO) Levels in Periodontal Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis
Inflammation
Trimethylamine N-oxide (TMAO)
TNF-alfa
Keywords: periodontal disease
TMAO
TNF-α
periodontitis
Lead sponsor: Ankara Medipol University
Sponsor class: OTHER
Collaborators: name: Istanbul Medipol University Hospital
name: Ankara University
name: Acibadem University
name: Lokman Hekim Üniversitesi
First posted: 2025-04-02
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Probing depth (PD)
timeFrame: Baseline
measure: Plaque index (PI)
timeFrame: Baseline
measure: Bleeding on probing (BOP)
timeFrame: Baseline
measure: Clinical attachment loss (CAL)
timeFrame: Baseline
measure: Age
timeFrame: Baseline
Secondary outcomes:
measure: Salivary and serum TMAO
timeFrame: Baseline
measure: Salivary and serum TNF-α levels
timeFrame: Baseline
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: İstanbul Medipol University, School of Dentistry
state: Fatih
Study officials:
References:
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