NCT07182448

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

1.2 years

First QC Date

September 11, 2025

Last Update Submit

September 18, 2025

Conditions

Keywords

hypoxiakynurenineoxidative stressperiodontitistryptophan

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 selected molecules

    3 months

Study Arms (2)

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.

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.

Other: Saliva and serum sampling

Interventions

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.

Saliva and serum collection of patients and samples molecules analysisSalivary and serum TNF-α, HIF-1α, 8-OhdG , KYN, TRP observation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Periodontally healthy and stage 3 garde B periodontitis patients were enrolled in this study

You may qualify if:

  • systemically healthy
  • clinical diagnosis of periodontitis
  • clinical diagnosis of periodontal health

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PeriodontitisHypoxia

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Prof

Study Record Dates

First Submitted

September 11, 2025

First Posted

September 19, 2025

Study Start

February 1, 2023

Primary Completion

April 3, 2024

Study Completion

August 22, 2024

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations