Gingival TrxR1 Expression in Periodontal Health and Periodontitis

NCT07598942 | Completed

• 2 other identifiers: B.30.2.ATA.0.01.00/163TDK-2023-13289
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Thioredoxin reductase 1; TrxR1

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (at the time of tissue collection)

Secondary Outcomes (4)

• Thioredoxin (TXN) mRNA Expression Levels

  Baseline (at the time of tissue collection)

• Thioredoxin-Interacting Protein (TXNIP) mRNA Expression Levels

  Baseline (at the time of tissue collection)

• Malondialdehyde (MDA) Levels.

  Baseline (at the time of tissue collection).

• Glutathione (GSH) Levels.

  Baseline (at the time of tissue collection).

Study Arms (3)

Healthy Control Group

Systemically and periodontally healthy individuals with no history of bone loss, probing depths ≤ 3 mm, and bleeding on probing \< 10%.

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.

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.

Other: Gingival Tissue Analysis

Interventions

Gingival Tissue Analysis OTHER

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.

Healthy Control Group; Stage 1-2 Periodontitis Group; Stage 3-4 Periodontitis Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Atatürk University Faculty of Dentistry

Erzurum, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start: August 30, 2023
• Primary Completion: August 10, 2025
• Study Completion: October 15, 2025
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning 6 months and ending 36 months following article publication.
• Access Criteria: Proposals should be directed to turgdemir@hotmail.com. To gain access, data requestors will need to sign a data access agreement.

Locations

TU (1)