PeriodontitisTMAONCT06906510
Evaluation of Trimethylamine N-oxide (TMAO) Levels in Periodontal Disease
An observational study of Periodontitis and Inflammation, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
Trial summary
Salivary and serum levels of TMAO and TNF-α can distinguish between individuals with periodontitis and periodontally healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Inflammation, Trimethylamine N-oxide (TMAO)
- What is being tested?
- Salivary and Serum TMAO Mesurement and Salivary and Serum TNF-α Mesurement
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jan 2024to 23 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- being over 18 and under 65 years of age;
- having at least 20 natural teeth excluding the third molars; and
- being systemically healthy.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Medipol University, School of Dentistry
Istanbul, Fatih, 34083
About this study
Salivary and serum levels of TMAO and TNF-α can distinguish between individuals with periodontitis and periodontally healthy individuals.
Read the 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.
- Conditions
- Periodontitis, Inflammation, Trimethylamine N-oxide (TMAO), TNF-alfa
- Being tested
- Salivary and Serum TMAO Mesurement, Salivary and Serum TNF-α Mesurement
- Keywords
- periodontal disease, TMAO, TNF-α, periodontitis
- Medical subject headings
- Periodontitis, Inflammation, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salivary and Serum TMAO MesurementDiagnostic test
Salivary and serum TMAO levels were measured by liquid chromatography-mass spectrometry (LC-MS/MS)
Salivary and Serum TNF-α MesurementDiagnostic test
Salivary and serum TNF-α levels were measured by ELISA
| Study group | Role | What they receive |
|---|---|---|
| Healthy Individuals | Systemically healthy individuals without periodontitis Receives: Diagnostic Test: Salivary and Serum TMAO Mesurement; Diagnostic Test: Salivary and Serum TNF-α Mesurement | |
| Patients with Periodontitis | Systemically healthy individuals with periodontitis Receives: Diagnostic Test: Salivary and Serum TMAO Mesurement; Diagnostic Test: Salivary and Serum TNF-α Mesurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth (PD)
Clinical parameters such as Probing depth (PD), Plaque index (PI), Bleeding on probing (BOP), and Clinical attachment loss (CAL) were recorded.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Age
Measured: Baseline
Secondary outcomes (2)
Salivary and serum TMAO
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.
Measured: Baseline
Salivary and serum TNF-α levels
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start8 Jan 2024
- Primary completion14 Aug 2024
- Study completion23 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Medipol University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Medipol University Hospital, Ankara University, Acibadem University, Lokman Hekim University
- Responsible party
- Principal investigator, Ceyhan CERAN SERDAR, Ankara Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906510
- Sponsor's protocol ID
- 1004
- Acronym
- TMAO
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21731245Engebretson 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.
PubMed 17116158Buczko 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.
PubMed 25716960Tonetti 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.
PubMed 29926952Hernandez-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.
PubMed 38415052Zhou 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.
PubMed 34472093Yang 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.
PubMed 25870193Wu 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.
PubMed 32291445
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Trimethylamine N-oxide (TMAO) Levels in Periodontal Disease
- ClinicalTrials.gov ID
- NCT06906510
- Acronym / sponsor ID
- TMAO / 1004
- Conditions
- Periodontitis, Inflammation, Trimethylamine N-oxide (TMAO), TNF-alfa
- Keywords
- periodontal disease, TMAO, TNF-α, periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ankara Medipol UniversityUniversity, hospital or other
- Collaborators
- Istanbul Medipol University Hospital, Ankara University, Acibadem University, Lokman Hekim University
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 14 Aug 2024 (actual)
- Study completion
- 23 Sep 2024 (actual)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Individuals | – | Diagnostic Test: Salivary and Serum TMAO Mesurement, Diagnostic Test: Salivary and Serum TNF-α MesurementSystemically healthy individuals without periodontitis |
| Patients with Periodontitis | – | Diagnostic Test: Salivary and Serum TMAO Mesurement, Diagnostic Test: Salivary and Serum TNF-α MesurementSystemically healthy individuals with periodontitis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- being over 18 and under 65 years of age;
- having at least 20 natural teeth excluding the third molars; and
- being systemically healthy.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salivary and Serum TMAO MesurementSalivary and serum TMAO levels were measured by liquid chromatography-mass spectrometry (LC-MS/MS) | Diagnostic test | Healthy Individuals, Patients with Periodontitis |
| Salivary and Serum TNF-α MesurementSalivary and serum TNF-α levels were measured by ELISA | Diagnostic test | Healthy Individuals, Patients with Periodontitis |
Primary outcome
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.
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.
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.
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.
Age
Time frame: Baseline
2 secondary outcomes
Salivary and serum TMAO
Time frame: Baseline
Salivary and serum TNF-α levels
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Background: PubMed 21731245Khanna 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.
- Background: PubMed 17116158Engebretson 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.
- Background: PubMed 25716960Buczko 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.
- Background: PubMed 29926952Tonetti 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.
- Background: PubMed 38415052Hernandez-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.
- Background: PubMed 34472093Zhou 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.
- Background: PubMed 25870193Yang 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.
- Background: PubMed 32291445Wu 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.
- Individual participant dataSharing planned: No
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis and Inflammation, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing depth (PD) (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06906510, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.