PeriodontitisNCT06580431
Trimethylamine N-oxide (TMAO) Levels in Periodontal Disease
A study testing Saliva and serum sampling in people with Periodontitis and Smoking, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Smoking, Inflammatory Response
- What is being tested?
- Saliva and serum sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Dec 2023to 25 Jun 2024
- Phase
- Interventional
- 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
Who may be able to join
- • 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.
Who cannot join
- decline to participate and being under 18 \& 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University, School of Dentistry
Istanbul, Fatih, 34083
About this study
Salivary and serum levels of TMAO and TNF-A can distinguish between individuals with periodontitis and periodontally healthy persons, including smoking and nonsmoking patients.
Read the detailed description
Tobacco use is a prevalent global habit with notable impacts on general health and periodontal disease. Trimethylamine N-oxide (TMAO) is a compound involved in the pathogenesis of various systemic inflammatory diseases, including cardiovascular conditions. The aim of this study was to determine differences in saliva and serum levels of TMAO between periodontitis and periodontally healthy patients according to smoking status.
The study includes four groups: systemically and periodontally healthy non-smokers (NS- Control; n = 25), systemically healthy non-smokers with Stage-III Grade-B periodontitis (NS- Periodontitis; n = 25), systemically and periodontally healthy smokers (S-Control; n = 25), and systemically healthy smokers with Stage-III Grade-C periodontitis (S-Periodontitis; n = 25). Periodontal parameters were recorded. TMAO levels were determined in saliva and serum samples using liquid chromatography-mass spectrometry (LC-MS/MS). TNF-α levels were measured by ELISA method.
- Conditions
- Periodontitis, Smoking, Inflammatory Response
- Being tested
- Saliva and serum sampling
- Keywords
- periodontal disease, smoking, TMAO
- Medical subject headings
- Periodontitis, Smoking, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva and serum samplingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Saliva and serum sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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
Measured: 4 months
Secondary outcomes (1)
serum and saliva analyses for TMAO levels
TMAO levels were determined in saliva and serum samples using liquid chromatography-mass spectrometry (LC-MS/MS). TNF-α levels were measured by ELISA method.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start21 Dec 2023
- Primary completion23 May 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Saliva and serum of periodontitis and smoking patients collected for analyzing TMAO levels
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nur Balci, DDs, PhD, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580431
- Sponsor's protocol ID
- 1061
- Status last verified
- Aug 2024
- First submitted
- 28 Aug 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20837180Bal 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.
PubMed 39887517
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trimethylamine N-oxide (TMAO) Levels in Periodontal Disease
- ClinicalTrials.gov ID
- NCT06580431
- Acronym / sponsor ID
- 1061
- Conditions
- Periodontitis, Smoking, Inflammatory Response
- Keywords
- periodontal disease, smoking, TMAO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 30 Aug 2024 (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-A can distinguish between individuals with periodontitis and periodontally healthy persons, including smoking and nonsmoking patients.
Detailed description
Tobacco use is a prevalent global habit with notable impacts on general health and periodontal disease. Trimethylamine N-oxide (TMAO) is a compound involved in the pathogenesis of various systemic inflammatory diseases, including cardiovascular conditions. The aim of this study was to determine differences in saliva and serum levels of TMAO between periodontitis and periodontally healthy patients according to smoking status.
The study includes four groups: systemically and periodontally healthy non-smokers (NS- Control; n = 25), systemically healthy non-smokers with Stage-III Grade-B periodontitis (NS- Periodontitis; n = 25), systemically and periodontally healthy smokers (S-Control; n = 25), and systemically healthy smokers with Stage-III Grade-C periodontitis (S-Periodontitis; n = 25). Periodontal parameters were recorded. TMAO levels were determined in saliva and serum samples using liquid chromatography-mass spectrometry (LC-MS/MS). TNF-α levels were measured by ELISA method.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Saliva and serum of periodontitis and smoking patients collected for analyzing TMAO levels
| Arm | Type | Receives |
|---|---|---|
| Active Comparator | Active comparator | Other: Saliva and serum samplingSaliva 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. |
| Salivary and serum TMAO observation | Experimental | Other: Saliva and serum samplingTNF-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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • systemically healthy
Key exclusion criteria (1 listed)
- decline to participate and being under 18 \& 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.
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 |
|---|---|---|
| Saliva and serum samplingSaliva 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 | Active Comparator, Salivary and serum TMAO observation |
Primary outcome
Pocket probing depth
Time frame: 3 months
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
Clinical attachment level
Time frame: 4 months
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)
Bleeding on probing
Time frame: 4 months
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
1 secondary outcome
serum and saliva analyses for TMAO levels
Time frame: 1 month
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 30 Aug 2024.
- Results publication: PubMed 20837180Di 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.
- Derived from this study: PubMed 39887517Bal 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.
- Individual participant dataSharing planned: No
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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?
A study testing Saliva and serum sampling in people with Periodontitis and Smoking, run by Istanbul Medipol University Hospital 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 4 inclusion and 1 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 30 Aug 2024. 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?
Pocket probing depth (time frame: 3 months). The study lists 3 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 NCT06580431, which also lists 2 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 30 Aug 2024.