PeriodontitisNCT07182448
Hypoxia and Kynurenine Pathway in Periodontal Inflammation
An observational study of Periodontitis and Diagnose Disease, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The kynurenine pathway (KP), the primary route for tryptophan (TRP) metabolism, is activated during inflammation and hypoxic conditions, contributing to immune dysregulation and oxidative stress. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontitis, Diagnose Disease
- What is being tested?
- Saliva and serum sampling
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 22 Aug 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
- No healthy volunteers
- Adult, Older adult
Study population: Periodontally healthy and stage 3 garde B periodontitis patients were enrolled in this study
Who may be able to join
- systemically healthy
- clinical diagnosis of periodontitis
- clinical diagnosis of periodontal health
Who cannot join
- decline to participate and being under 18 \& over 65 years of age;
- having any systemic inflammatory diseases such as diabetes, rheumatoid arthritis, or systemic conditions, including immunodeficiency syndrome, cardiovascular disorders, or hepatic disorders;
- the use of antibiotics and/or anti-inflammatory nonsteroidal anti-inflammatory drugs within 3 months preceding the study;
- having nonsurgical periodontal treatment (previous 6 months);
- having surgical periodontal treatment (previous 12 months);
- having <20 natural teeth excluding the third molars.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interaction of Hypoxia and Kynurenine Pathway in Periodontal Inflammation
The kynurenine pathway (KP), the primary route for tryptophan (TRP) metabolism, is activated during inflammation and hypoxic conditions, contributing to immune dysregulation and oxidative stress. the interconnected roles of hypoxia, KP activation, and oxidative stress in periodontitis have not been comprehensively investigated.The aim of this study was to determine the role of the kynurenine (KYN) pathway and hypoxia in periodontal inflammation, as well as their association with periodontal clinical parameters.
Read the detailed description
Systemically healthy 23 stage III, grade B periodontitis patients and 22 periodontally healthy individuals were included in this study. Salivary and serum tumor necrosis factor-alpha (TNF-α), hypoxia-inducible factor-1 alpha (HIF-1α) and 8-hydroxy-2'-deoxyguanosine (8-OhdG) levels were evaluated by ELISA, and salivary and serum KP metabolites were evaluated by liquid chromatography-mass spectrometry.
- Conditions
- Periodontitis, Diagnose Disease
- Being tested
- Saliva and serum sampling
- Keywords
- hypoxia, kynurenine, oxidative stress, periodontitis, tryptophan
- Medical subject headings
- Periodontitis, Hypoxia
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 (MFD) from each participant. Saliva and serum were then stored at -80 °C until analysis.
| Study group | Role | What they receive |
|---|---|---|
| Saliva and serum collection of patients and samples molecules analysis | 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 TNF-α, HIF-1α, 8-OhdG , KYN, TRP observation | Salivary and serum tumor necrosis factor-alpha (TNF-α), hypoxia-inducible factor-1 alpha (HIF-1α) and 8-hydroxy-2'-deoxyguanosine (8-OhdG) levels were evaluated by ELISA, and salivary and serum KP metabolites were evaluated by liquid chromatography-mass spectrometry. 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 selected molecules
ELISA method was used for tumor necrosis factor-alpha (TNF-α), hypoxia-inducible factor-1 alpha (HIF-1α) and 8-hydroxy-2'-deoxyguanosine (8-OhdG) levels evaluation. KP metabolites were evaluated by liquid chromatography-mass spectrometry.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start1 Feb 2023
- Primary completion3 Apr 2024
- Study completion22 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara University
- Responsible party
- Principal investigator, Nur Balci, DDs, PhD, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182448
- Sponsor's protocol ID
- 1124
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction of Hypoxia and Kynurenine Pathway in Periodontal Inflammation
- ClinicalTrials.gov ID
- NCT07182448
- Acronym / sponsor ID
- 1124
- Conditions
- Periodontitis, Diagnose Disease
- Keywords
- hypoxia, kynurenine, oxidative stress, periodontitis, tryptophan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Collaborators
- Ankara University
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 3 Apr 2024 (actual)
- Study completion
- 22 Aug 2024 (actual)
- First posted
- 19 Sep 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.
The kynurenine pathway (KP), the primary route for tryptophan (TRP) metabolism, is activated during inflammation and hypoxic conditions, contributing to immune dysregulation and oxidative stress. the interconnected roles of hypoxia, KP activation, and oxidative stress in periodontitis have not been comprehensively investigated.The aim of this study was to determine the role of the kynurenine (KYN) pathway and hypoxia in periodontal inflammation, as well as their association with periodontal clinical parameters.
Detailed description
Systemically healthy 23 stage III, grade B periodontitis patients and 22 periodontally healthy individuals were included in this study. Salivary and serum tumor necrosis factor-alpha (TNF-α), hypoxia-inducible factor-1 alpha (HIF-1α) and 8-hydroxy-2'-deoxyguanosine (8-OhdG) levels were evaluated by ELISA, and salivary and serum KP metabolites were evaluated by liquid chromatography-mass spectrometry.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saliva and serum collection of patients and samples molecules analysis | – | 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 TNF-α, HIF-1α, 8-OhdG , KYN, TRP observation | – | Other: Saliva and serum samplingSalivary and serum tumor necrosis factor-alpha (TNF-α), hypoxia-inducible factor-1 alpha (HIF-1α) and 8-hydroxy-2'-deoxyguanosine (8-OhdG) levels were evaluated by ELISA, and salivary and serum KP metabolites were evaluated by liquid chromatography-mass spectrometry. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Periodontally healthy and stage 3 garde B periodontitis patients were enrolled in this study
Key inclusion criteria (3 listed)
- systemically healthy
- clinical diagnosis of periodontitis
- clinical diagnosis of periodontal health
Key exclusion criteria (6 listed)
- decline to participate and being under 18 \& over 65 years of age;
- having any systemic inflammatory diseases such as diabetes, rheumatoid arthritis, or systemic conditions, including immunodeficiency syndrome, cardiovascular disorders, or hepatic disorders;
- the use of antibiotics and/or anti-inflammatory nonsteroidal anti-inflammatory drugs within 3 months preceding the study;
- having nonsurgical periodontal treatment (previous 6 months);
- having surgical periodontal treatment (previous 12 months);
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 (MFD) from each participant. Saliva and serum were then stored at -80 °C until analysis. | Other | Saliva and serum collection of patients and samples molecules analysis, Salivary and serum TNF-α, HIF-1α, 8-OhdG , KYN, TRP 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 selected molecules
Time frame: 3 months
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 19 Sep 2025.
- 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?
An observational study of Periodontitis and Diagnose Disease, 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 3 inclusion and 6 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 19 Sep 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?
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?
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 19 Sep 2025.