PeriodontitisNCT07598942
Gingival TrxR1 Expression in Periodontal Health and Periodontitis
An observational study of Periodontitis and Oxidative Stress, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Oxidative Stress
- What is being tested?
- Gingival Tissue Analysis
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2023to 15 Oct 2025
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients visiting the Department of Periodontology at Atatürk University Faculty of Dentistry who meet the clinical criteria for health or periodontitis.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk University Faculty of Dentistry
Erzurum, 25240
About this study
Official title: 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.
- Conditions
- Periodontitis, Oxidative Stress
- Being tested
- Gingival Tissue Analysis
- Keywords
- Thioredoxin reductase 1, TrxR1
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingival Tissue AnalysisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control Group | Systemically and periodontally healthy individuals with no history of bone loss, probing depths ≤ 3 mm, and bleeding on probing < 10%. Receives: Other: Gingival Tissue Analysis | |
| 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. Receives: Other: Gingival Tissue Analysis | |
| 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. Receives: Other: Gingival Tissue Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thioredoxin Reductase 1 (TrxR1) mRNA Expression Levels
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.
Measured: Baseline (at the time of tissue collection)
Secondary outcomes (4)
Thioredoxin (TXN) mRNA Expression Levels
Evaluation of TXN gene expression levels in gingival tissue samples using quantitative real-time PCR (qPCR) normalized to β-actin.
Measured: Baseline (at the time of tissue collection)
Thioredoxin-Interacting Protein (TXNIP) mRNA Expression Levels
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)
Measured: Baseline (at the time of tissue collection)
Malondialdehyde (MDA) Levels.
MDA levels in gingival tissue homogenates measured using the thiobarbituric acid reactive substances (TBARS) assay to evaluate lipid peroxidation.
Measured: Baseline (at the time of tissue collection).
Glutathione (GSH) Levels.
GSH levels in gingival tissue homogenates measured using spectroscopic methods to evaluate antioxidant status.
Measured: Baseline (at the time of tissue collection).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start30 Aug 2023
- Primary completion10 Aug 2025
- Study completion15 Oct 2025
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.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fuat Cetinkaya, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598942
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/163
- Other IDs
- TDK-2023-13289
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification, will be made available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thioredoxin Reductase 1 Levels in Gingival Tissue as an Oxidative Stress Biomarker in Periodontitis
- ClinicalTrials.gov ID
- NCT07598942
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/163
- Conditions
- Periodontitis, Oxidative Stress
- Keywords
- Thioredoxin reductase 1, TrxR1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 10 Aug 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 20 May 2026 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Control Group | – | Other: Gingival Tissue AnalysisSystemically and periodontally healthy individuals with no history of bone loss, probing depths ≤ 3 mm, and bleeding on probing < 10%. |
| Stage 1-2 Periodontitis Group | – | Other: Gingival Tissue AnalysisPatients 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. |
| Stage 3-4 Periodontitis Group | – | Other: Gingival Tissue AnalysisPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients visiting the Department of Periodontology at Atatürk University Faculty of Dentistry who meet the clinical criteria for health or periodontitis.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Gingival Tissue AnalysisGingival 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. | Other | Healthy Control Group, Stage 1-2 Periodontitis Group, Stage 3-4 Periodontitis Group |
Primary outcome
Thioredoxin Reductase 1 (TrxR1) mRNA Expression Levels
Time frame: Baseline (at the time of tissue collection)
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.
4 secondary outcomes
Thioredoxin (TXN) mRNA Expression Levels
Time frame: Baseline (at the time of tissue collection)
Thioredoxin-Interacting Protein (TXNIP) mRNA Expression Levels
Time frame: Baseline (at the time of tissue collection)
Malondialdehyde (MDA) Levels.
Time frame: Baseline (at the time of tissue collection).
Glutathione (GSH) Levels.
Time frame: Baseline (at the time of tissue collection).
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 20 May 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification, will be made available upon request.
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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 Oxidative Stress, run by Ataturk 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 5 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 20 May 2026. 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?
Thioredoxin Reductase 1 (TrxR1) mRNA Expression Levels (time frame: Baseline (at the time of tissue collection)). 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 20 May 2026.