- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07598942
Gingival TrxR1 Expression in Periodontal Health and Periodontitis
May 14, 2026 updated by: Fuat Cetinkaya, Ataturk University
Thioredoxin Reductase 1 Levels in Gingival Tissue as an Oxidative Stress Biomarker in Periodontitis
This study aims to investigate the role of the thioredoxin system in the development and progression of periodontitis.
Researchers will examine the levels of specific antioxidant markers, such as thioredoxin reductase 1 (TrxR1), glutathione (GSH), and malondialdehyde (MDA), in gingival tissue samples collected from healthy individuals and patients with different stages of periodontal disease.
The goal is to determine if TrxR1 levels can serve as a potential biomarker for diagnosing the severity and activity of periodontitis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Erzurum, Turkey (Türkiye), 25240
- Atatürk University Faculty of Dentistry
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Patients visiting the Department of Periodontology at Atatürk University Faculty of Dentistry who meet the clinical criteria for health or periodontitis.
Description
Inclusion Criteria:
- Being between the ages of 18 and 70.
- Having no known systemic disease.
- Non-smokers.
- No history of medication or supplement use in the last 3 months.
- For the Periodontitis groups: Interdental clinical attachment loss (CAL), probing pocket depth (PPD), and radiographic bone loss according to 2017 World Workshop criteria.
Exclusion Criteria:
- Smoking.
- Pregnancy or breastfeeding.
- Presence of a systemic disease (e.g., diabetes mellitus, hypertension, rheumatoid arthritis, cancer, thyroid disorders, kidney or lung diseases).
- History of any periodontal surgical procedure within the last 6 months.
- Use of medication or supplements within the last 3 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthy Control Group
Systemically and periodontally healthy individuals with no history of bone loss, probing depths ≤ 3 mm, and bleeding on probing < 10%.
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Gingival tissue samples are collected from all participants.
These samples are analyzed for Glutathione (GSH) and Malondialdehyde (MDA) levels using spectroscopic methods.
Additionally, the expression of thioredoxin reductase 1 (TrxR1), thioredoxin (TXN), and thioredoxin-interacting protein (TXNIP) is determined through quantitative real-time PCR, western blot, and enzyme activity assays.
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Stage 1-2 Periodontitis Group
Patients diagnosed with Stage 1 or Stage 2 periodontitis according to the 2017 World Workshop classification, characterized by interdental clinical attachment loss and radiographic bone loss.
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Gingival tissue samples are collected from all participants.
These samples are analyzed for Glutathione (GSH) and Malondialdehyde (MDA) levels using spectroscopic methods.
Additionally, the expression of thioredoxin reductase 1 (TrxR1), thioredoxin (TXN), and thioredoxin-interacting protein (TXNIP) is determined through quantitative real-time PCR, western blot, and enzyme activity assays.
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Stage 3-4 Periodontitis Group
Patients diagnosed with Stage 3 or Stage 4 periodontitis, characterized by severe clinical attachment loss, deep probing depths, and significant radiographic bone loss potentially leading to tooth loss.
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Gingival tissue samples are collected from all participants.
These samples are analyzed for Glutathione (GSH) and Malondialdehyde (MDA) levels using spectroscopic methods.
Additionally, the expression of thioredoxin reductase 1 (TrxR1), thioredoxin (TXN), and thioredoxin-interacting protein (TXNIP) is determined through quantitative real-time PCR, western blot, and enzyme activity assays.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Thioredoxin Reductase 1 (TrxR1) mRNA Expression Levels
Time Frame: Baseline (at the time of tissue collection)
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The expression levels of TrxR1 in gingival tissue are determined by quantitative real-time PCR (qPCR).
This measure evaluates the potential of TrxR1 as a biomarker for periodontitis severity.
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Baseline (at the time of tissue collection)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Thioredoxin (TXN) mRNA Expression Levels
Time Frame: Baseline (at the time of tissue collection)
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Evaluation of TXN gene expression levels in gingival tissue samples using quantitative real-time PCR (qPCR) normalized to β-actin.
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Baseline (at the time of tissue collection)
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Thioredoxin-Interacting Protein (TXNIP) mRNA Expression Levels
Time Frame: Baseline (at the time of tissue collection)
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Evaluation of TXNIP gene expression levels in gingival tissue samples using quantitative real-time PCR (qPCR) normalized to β-actin. Time Frame: Baseline (at the time of tissue collection) |
Baseline (at the time of tissue collection)
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Malondialdehyde (MDA) Levels.
Time Frame: Baseline (at the time of tissue collection).
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MDA levels in gingival tissue homogenates measured using the thiobarbituric acid reactive substances (TBARS) assay to evaluate lipid peroxidation.
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Baseline (at the time of tissue collection).
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Glutathione (GSH) Levels.
Time Frame: Baseline (at the time of tissue collection).
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GSH levels in gingival tissue homogenates measured using spectroscopic methods to evaluate antioxidant status.
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Baseline (at the time of tissue collection).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 30, 2023
Primary Completion (Actual)
August 10, 2025
Study Completion (Actual)
October 15, 2025
Study Registration Dates
First Submitted
May 14, 2026
First Submitted That Met QC Criteria
May 14, 2026
First Posted (Actual)
May 20, 2026
Study Record Updates
Last Update Posted (Actual)
May 20, 2026
Last Update Submitted That Met QC Criteria
May 14, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B.30.2.ATA.0.01.00/163
- TDK-2023-13289 (Other Identifier: Atatürk University Scientific Research Projects)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual participant data that underlie the results reported in this article, after de-identification, will be made available upon request.
IPD Sharing Time Frame
Data will be available beginning 6 months and ending 36 months following article publication.
IPD Sharing Access Criteria
Proposals should be directed to turgdemir@hotmail.com.
To gain access, data requestors will need to sign a data access agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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